Last Updated: June 27, 2026

Expiring Drug Patents Cheat Sheet
We analyse the patents covering drugs in 134 countries and quickly give you the likely loss-of-exclusivity/generic entry date

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Australia: These 55 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "Australia: These 55 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.
When can BYDUREON (exenatide synthetic) generic drug versions launch in Australia?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Australia Patent 2,007,265,246

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug.

This drug has three hundred and seven patent family members in forty-eight countries. There has been litigation on patents covering BYDUREON

See drug price trends for BYDUREON.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the exenatide synthetic profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch in Australia?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Australia Patent 2,007,265,246

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are seventeen patents protecting this drug and one Paragraph IV challenge. Fourteen tentatively approved generics are ready to enter the market.

This drug has four hundred and twenty-seven patent family members in fifty-three countries. There has been litigation on patents covering FARXIGA

See drug price trends for FARXIGA.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch in Australia?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Australia Patent 2,007,265,246

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifty-six patent family members in forty-eight countries. There has been litigation on patents covering QTERN

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Australia?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Australia Patent 2,007,275,860
Patent Title: Modulators of pharmacokinetic properties of therapeutics

Drug Price Trends for EVOTAZ
EVOTAZ is a drug marketed by Bristol. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and six patent family members in forty-one countries. There has been litigation on patents covering EVOTAZ

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Australia?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Australia Patent 2,008,218,186
Patent Title: Modulators of pharmacokinetic properties of therapeutics

Drug Price Trends for EVOTAZ
EVOTAZ is a drug marketed by Bristol. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and six patent family members in forty-one countries. There has been litigation on patents covering EVOTAZ

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Australia?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Australia Patent 2,008,275,744
Patent Title: Modulators of pharmacokinetic properties of therapeutics

Drug Price Trends for EVOTAZ
EVOTAZ is a drug marketed by Bristol. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and six patent family members in forty-one countries. There has been litigation on patents covering EVOTAZ

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EPIDUO (adapalene; benzoyl peroxide) generic drug versions launch in Australia?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Australia Patent 2,007,274,288
Patent Title: Combination of adapalene and benzoyl peroxide for treating acne lesions

Drug Price Trends for EPIDUO
EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in twenty-two countries. There has been litigation on patents covering EPIDUO

See drug price trends for EPIDUO.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can EPIDUO FORTE (adapalene; benzoyl peroxide) generic drug versions launch in Australia?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Australia Patent 2,007,274,288
Patent Title: Combination of adapalene and benzoyl peroxide for treating acne lesions

Drug Price Trends for EPIDUO FORTE
EPIDUO FORTE is a drug marketed by Galderma Labs.

This drug has thirty-five patent family members in twenty-two countries. There has been litigation on patents covering EPIDUO FORTE

See drug price trends for EPIDUO FORTE.

The generic ingredient in EPIDUO FORTE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can SALONPAS (menthol; methyl salicylate) generic drug versions launch in Australia?

Generic name: menthol; methyl salicylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: Australia Patent 2,007,279,643
Patent Title: Adhesive preparation

SALONPAS is a drug marketed by Hisamitsu Pharm Co. There are two patents protecting this drug.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in SALONPAS is menthol; methyl salicylate. There are eighteen drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the menthol; methyl salicylate profile page.

When can DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch in Australia?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Australia Patent 2,007,286,222
Patent Title: Hepatitis C virus inhibitors

Drug Price Trends for DAKLINZA
DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

This drug has ninety-three patent family members in thirty-one countries. There has been litigation on patents covering DAKLINZA

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.

When can BRILINTA (ticagrelor) generic drug versions launch in Australia?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: Australia Patent 2,007,288,541

Drug Price Trends for BRILINTA
BRILINTA is a drug marketed by Astrazeneca. There are two patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has sixty-two patent family members in thirty-five countries. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this API. Twenty-seven suppliers are listed for this generic product. Additional details are available on the ticagrelor profile page.

When can BRILINTA (ticagrelor) generic drug versions launch in Australia?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: Australia Patent 2,011,205,164

Drug Price Trends for BRILINTA
BRILINTA is a drug marketed by Astrazeneca. There are two patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has sixty-two patent family members in thirty-five countries. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this API. Twenty-seven suppliers are listed for this generic product. Additional details are available on the ticagrelor profile page.

When can OPSUMIT (macitentan) generic drug versions launch in Australia?

Generic name: macitentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: Australia Patent 2,007,290,099

OPSUMIT is a drug marketed by Actelion. There are five patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has one hundred and one patent family members in thirty-five countries. There has been litigation on patents covering OPSUMIT

See drug price trends for OPSUMIT.

The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the macitentan profile page.

When can LIVDELZI (seladelpar lysine) generic drug versions launch in Australia?

Generic name: seladelpar lysine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 13, 2026
Generic Entry Controlled by: Australia Patent 2,006,291,006

LIVDELZI is a drug marketed by Gilead Sciences Inc. There are six patents protecting this drug.

This drug has one hundred and thirty-eight patent family members in forty-six countries.

The generic ingredient in LIVDELZI is seladelpar lysine. One supplier is listed for this generic product. Additional details are available on the seladelpar lysine profile page.

When can CRESEMBA (isavuconazonium sulfate) generic drug versions launch in Australia?

Generic name: isavuconazonium sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 25, 2026
Generic Entry Controlled by: Australia Patent 2,007,302,320
Patent Title: Active ingredient containing stabilised solid medicinal forms and method for the production thereof

Drug Price Trends for CRESEMBA
CRESEMBA is a drug marketed by Astellas. There are three patents protecting this drug.

This drug has thirty-two patent family members in nineteen countries. There has been litigation on patents covering CRESEMBA

See drug price trends for CRESEMBA.

The generic ingredient in CRESEMBA is isavuconazonium sulfate. One supplier is listed for this generic product. Additional details are available on the isavuconazonium sulfate profile page.

When can TYMLOS (abaloparatide) generic drug versions launch in Australia?

Generic name: abaloparatide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Australia Patent 2,007,322,334
Patent Title: Method of drug delivery for bone anabolic protein

Drug Price Trends for TYMLOS
TYMLOS is a drug marketed by Radius. There are nine patents protecting this drug.

This drug has fifty-six patent family members in twenty-nine countries. There has been litigation on patents covering TYMLOS

See drug price trends for TYMLOS.

The generic ingredient in TYMLOS is abaloparatide. One supplier is listed for this generic product. Additional details are available on the abaloparatide profile page.

When can INREBIC (fedratinib hydrochloride) generic drug versions launch in Australia?

Generic name: fedratinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: Australia Patent 2,006,309,013

INREBIC is a drug marketed by Bristol-myers. There are five patents protecting this drug.

This drug has one hundred and nineteen patent family members in forty-two countries. There has been litigation on patents covering INREBIC

See drug price trends for INREBIC.

The generic ingredient in INREBIC is fedratinib hydrochloride. One supplier is listed for this generic product. Additional details are available on the fedratinib hydrochloride profile page.

When can BEVYXXA (betrixaban) generic drug versions launch in Australia?

Generic name: betrixaban
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 07, 2026
Generic Entry Controlled by: Australia Patent 2,006,311,544
Patent Title: Novel pharmaceutical salts and polymorphs of a factor Xa inhibitor

BEVYXXA is a drug marketed by Portola Pharms Inc. There are five patents protecting this drug.

This drug has sixty-seven patent family members in twenty-six countries. There has been litigation on patents covering BEVYXXA

See drug price trends for BEVYXXA.

The generic ingredient in BEVYXXA is betrixaban. Additional details are available on the betrixaban profile page.

When can PYLARIFY (piflufolastat f-18) generic drug versions launch in Australia?

Generic name: piflufolastat f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Australia Patent 2,007,316,391

PYLARIFY is a drug marketed by Progenics Pharms Inc and AphelionThere are six patents protecting this drug.

This drug has one hundred and sixteen patent family members in twenty-seven countries.

See drug price trends for PYLARIFY.

The generic ingredient in PYLARIFY is piflufolastat f-18. One supplier is listed for this generic product. Additional details are available on the piflufolastat f-18 profile page.

When can PYLARIFY TRUVU (piflufolastat f-18) generic drug versions launch in Australia?

Generic name: piflufolastat f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Australia Patent 2,007,316,391

PYLARIFY TRUVU is a drug marketed by Aphelion. There are six patents protecting this drug.

This drug has one hundred and sixteen patent family members in twenty-seven countries.

The generic ingredient in PYLARIFY TRUVU is piflufolastat f-18. One supplier is listed for this generic product. Additional details are available on the piflufolastat f-18 profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch in Australia?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Australia Patent 2,007,317,817

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch in Australia?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Australia Patent 2,007,319,831

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can SOFDRA (sofpironium bromide) generic drug versions launch in Australia?

Generic name: sofpironium bromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 13, 2026
Generic Entry Controlled by: Australia Patent 2,006,315,657

SOFDRA is a drug marketed by Botanix Sb. There are twenty patents protecting this drug.

This drug has one hundred and sixty-five patent family members in twenty-six countries. There has been litigation on patents covering SOFDRA

The generic ingredient in SOFDRA is sofpironium bromide. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the sofpironium bromide profile page.

When can AXUMIN (fluciclovine f-18) generic drug versions launch in Australia?

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: Australia Patent 2,006,319,987
Patent Title: Precursor compound of radioactive halogen labeled organic compound

AXUMIN is a drug marketed by Blue Earth. There are eight patents protecting this drug.

This drug has thirty patent family members in sixteen countries. There has been litigation on patents covering AXUMIN

The generic ingredient in AXUMIN is fluciclovine f-18. One supplier is listed for this generic product. Additional details are available on the fluciclovine f-18 profile page.

When can ZTALMY (ganaxolone) generic drug versions launch in Australia?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: Australia Patent 2,006,318,349

ZTALMY is a drug marketed by Immedica Pharma. There are eleven patents protecting this drug.

This drug has forty-nine patent family members in sixteen countries. There has been litigation on patents covering ZTALMY

See drug price trends for ZTALMY.

The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this generic product. Additional details are available on the ganaxolone profile page.

When can SIRTURO (bedaquiline fumarate) generic drug versions launch in Australia?

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Australia Patent 2,007,328,945

SIRTURO is a drug marketed by Janssen Therap. There are two patents protecting this drug.

This drug has ninety-seven patent family members in thirty-nine countries.

See drug price trends for SIRTURO.

The generic ingredient in SIRTURO is bedaquiline fumarate. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the bedaquiline fumarate profile page.

When can ZYKADIA (ceritinib) generic drug versions launch in Australia?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Australia Patent 2,007,333,394

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ceritinib profile page.

When can ZYKADIA (ceritinib) generic drug versions launch in Australia?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Australia Patent 2,008,296,479

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ceritinib profile page.

When can ZYKADIA (ceritinib) generic drug versions launch in Australia?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Australia Patent 2,008,296,545

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ceritinib profile page.

When can ZYKADIA (ceritinib) generic drug versions launch in Australia?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Australia Patent 2,010,210,018

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ceritinib profile page.

When can ZYKADIA (ceritinib) generic drug versions launch in Australia?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Australia Patent 2,010,210,019

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ceritinib profile page.

When can LETAIRIS (ambrisentan) generic drug versions launch in Australia?

Generic name: ambrisentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Australia Patent 2,007,333,115
Patent Title: Composition for treating a pulmonary hypertension

LETAIRIS is a drug marketed by Gilead. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-one patent family members in twenty-six countries. There has been litigation on patents covering LETAIRIS

See drug price trends for LETAIRIS.

The generic ingredient in LETAIRIS is ambrisentan. There are nine drug master file entries for this API. Thirteen suppliers are listed for this generic product. Additional details are available on the ambrisentan profile page.

When can XERMELO (telotristat etiprate) generic drug versions launch in Australia?

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Australia Patent 2,007,333,120

XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.

This drug has seventy patent family members in twenty-nine countries.

See drug price trends for XERMELO.

The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this generic product. Additional details are available on the telotristat etiprate profile page.

When can VYKAT XR (diazoxide choline) generic drug versions launch in Australia?

Generic name: diazoxide choline
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 20, 2026
Generic Entry Controlled by: Australia Patent 2,006,335,153

VYKAT XR is a drug marketed by Soleno Therap. There are six patents protecting this drug.

This drug has seventy-nine patent family members in twenty-two countries.

The generic ingredient in VYKAT XR is diazoxide choline. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the diazoxide choline profile page.

When can SEYSARA (sarecycline hydrochloride) generic drug versions launch in Australia?

Generic name: sarecycline hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2026
Generic Entry Controlled by: Australia Patent 2,007,338,681
Patent Title: Substituted tetracycline compounds for treatment of inflammatory skin disorders

SEYSARA is a drug marketed by Almirall. There are four patents protecting this drug.

This drug has seventy-two patent family members in twenty countries.

See drug price trends for SEYSARA.

The generic ingredient in SEYSARA is sarecycline hydrochloride. One supplier is listed for this generic product. Additional details are available on the sarecycline hydrochloride profile page.

When can EPSOLAY (benzoyl peroxide) generic drug versions launch in Australia?

Generic name: benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Australia Patent 2,008,211,554
Patent Title: Method for preparing particles comprising metal oxide coating and particles with metal oxide coating

Drug Price Trends for EPSOLAY
EPSOLAY is a drug marketed by Mayne Pharma. There are fourteen patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has fifty-one patent family members in fifteen countries. There has been litigation on patents covering EPSOLAY

See drug price trends for EPSOLAY.

The generic ingredient in EPSOLAY is benzoyl peroxide. There are seventeen drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the benzoyl peroxide profile page.

When can OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch in Australia?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Australia Patent 2,008,211,981

Drug Price Trends for OSENI
OSENI is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.

This drug has one hundred and one patent family members in forty-two countries. There has been litigation on patents covering OSENI

See drug price trends for OSENI.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are ten drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.

When can PANCREAZE (pancrelipase (amylase;lipase;protease)) generic drug versions launch in Australia?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Australia Patent 2,008,218,595

PANCREAZE is a drug marketed by

This drug has one hundred and one patent family members in forty-two countries.

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can ZENPEP (pancrelipase (amylase;lipase;protease)) generic drug versions launch in Australia?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Australia Patent 2,008,218,595

ZENPEP is a drug marketed by

This drug has one hundred and one patent family members in forty-two countries.

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can PRESTALIA (amlodipine besylate; perindopril arginine) generic drug versions launch in Australia?

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 26, 2027
Generic Entry Controlled by: Australia Patent 2,007,220,435

PRESTALIA is a drug marketed by Adhera. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty-seven countries. There has been litigation on patents covering PRESTALIA

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this API. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

When can SPRAVATO (esketamine hydrochloride) generic drug versions launch in Australia?

Generic name: esketamine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Australia Patent 2,007,229,866
Patent Title: Intranasal administration of ketamine to treat depression

Drug Price Trends for SPRAVATO
SPRAVATO is a drug marketed by Janssen Pharms. There are seven patents protecting this drug.

This drug has sixty-two patent family members in twenty-four countries. There has been litigation on patents covering SPRAVATO

See drug price trends for SPRAVATO.

The generic ingredient in SPRAVATO is esketamine hydrochloride. One supplier is listed for this generic product. Additional details are available on the esketamine hydrochloride profile page.

When can XENLETA (lefamulin acetate) generic drug versions launch in Australia?

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Australia Patent 2,008,229,609

XENLETA is a drug marketed by Hong Kong. There are four patents protecting this drug.

This drug has one hundred and twenty patent family members in thirty-six countries. There has been litigation on patents covering XENLETA

See drug price trends for XENLETA.

The generic ingredient in XENLETA is lefamulin acetate. Additional details are available on the lefamulin acetate profile page.

When can EDARBI (azilsartan kamedoxomil) generic drug versions launch in Australia?

Generic name: azilsartan kamedoxomil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 28, 2027
Generic Entry Controlled by: Australia Patent 2,008,235,790
Patent Title: Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent

Drug Price Trends for EDARBI
EDARBI is a drug marketed by Azurity. There is one patent protecting this drug.

This drug has twenty-one patent family members in seventeen countries. There has been litigation on patents covering EDARBI

See drug price trends for EDARBI.

The generic ingredient in EDARBI is azilsartan kamedoxomil. There are six drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the azilsartan kamedoxomil profile page.

When can INLYTA (axitinib) generic drug versions launch in Australia?

Generic name: axitinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 05, 2027
Generic Entry Controlled by: Australia Patent 2,008,236,444
Patent Title: Crystalline forms of 6- [2- (methylcarbamoyl) phenylsulfanyl] -3-E- [2- (pyridin-2-yl) ethenyl] indazole suitable for the treatment of abnormal cell growth in mammals

INLYTA is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has ninety-seven patent family members in thirty countries. There has been litigation on patents covering INLYTA

See drug price trends for INLYTA.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the axitinib profile page.

When can QVAR REDIHALER (beclomethasone dipropionate) generic drug versions launch in Australia?

Generic name: beclomethasone dipropionate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 11, 2027
Generic Entry Controlled by: Australia Patent 2,008,234,098

Drug Price Trends for QVAR REDIHALER
QVAR REDIHALER is a drug marketed by Norton Waterford. There are seventeen patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has two hundred and seventy-eight patent family members in twenty-seven countries. There has been litigation on patents covering QVAR REDIHALER

See drug price trends for QVAR REDIHALER.

The generic ingredient in QVAR REDIHALER is beclomethasone dipropionate. There are twenty drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the beclomethasone dipropionate profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch in Australia?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Australia Patent 2,007,352,608
Patent Title: Novel pharmaceutical composition

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-five patent family members in forty-one countries. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch in Australia?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Australia Patent 2,012,201,288
Patent Title: Novel pharmaceutical composition

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-five patent family members in forty-one countries. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch in Australia?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Australia Patent 2,014,202,367
Patent Title: NOVEL PHARMACEUTICAL COMPOSITION

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-five patent family members in forty-one countries. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch in Australia?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Australia Patent 2,016,202,063
Patent Title: NOVEL PHARMACEUTICAL COMPOSITION

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-five patent family members in forty-one countries. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can ICLUSIG (ponatinib hydrochloride) generic drug versions launch in Australia?

Generic name: ponatinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 08, 2027
Generic Entry Controlled by: Australia Patent 2,007,249,924

ICLUSIG is a drug marketed by Takeda Pharms Usa. There are six patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has one hundred and nine patent family members in twenty-four countries. There has been litigation on patents covering ICLUSIG

See drug price trends for ICLUSIG.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the ponatinib hydrochloride profile page.

When can VRAYLAR (cariprazine hydrochloride) generic drug versions launch in Australia?

Generic name: cariprazine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 11, 2027
Generic Entry Controlled by: Australia Patent 2,008,249,772

Drug Price Trends for VRAYLAR
VRAYLAR is a drug marketed by Abbvie. There are five patents protecting this drug.

This drug has one hundred and twenty-one patent family members in forty-two countries. There has been litigation on patents covering VRAYLAR

See drug price trends for VRAYLAR.

The generic ingredient in VRAYLAR is cariprazine hydrochloride. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the cariprazine hydrochloride profile page.

When can TRELSTAR (triptorelin pamoate) generic drug versions launch in Australia?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Australia Patent 2,008,259,411
Patent Title: Slow release pharmaceutical composition made of microparticles

TRELSTAR is a drug marketed by Verity. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

See drug price trends for TRELSTAR.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can TRIPTODUR KIT (triptorelin pamoate) generic drug versions launch in Australia?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Australia Patent 2,008,259,411
Patent Title: Slow release pharmaceutical composition made of microparticles

TRIPTODUR KIT is a drug marketed by Azurity. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-two countries.

The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can JAKAFI (ruxolitinib phosphate) generic drug versions launch in Australia?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Australia Patent 2,008,266,183
Patent Title: Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile

JAKAFI is a drug marketed by Incyte Corp. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-six patent family members in forty-six countries. There has been litigation on patents covering JAKAFI

See drug price trends for JAKAFI.

The generic ingredient in JAKAFI is ruxolitinib phosphate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ruxolitinib phosphate profile page.

When can KYBELLA (deoxycholic acid) generic drug versions launch in Australia?

Generic name: deoxycholic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Australia Patent 2,008,265,721
Patent Title: Synthetic bile acid composition, method, and preparation

KYBELLA is a drug marketed by Abbvie. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-six patent family members in thirty-eight countries. There has been litigation on patents covering KYBELLA

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the deoxycholic acid profile page.

When can JESDUVROQ (daprodustat) generic drug versions launch in Australia?

Generic name: daprodustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 22, 2027
Generic Entry Controlled by: Australia Patent 2,007,260,837
Patent Title: Prolyl hydroxylase inhibitors

JESDUVROQ is a drug marketed by Glaxosmithkline. There are six patents protecting this drug.

This drug has forty-four patent family members in thirty-one countries.

See drug price trends for JESDUVROQ.

The generic ingredient in JESDUVROQ is daprodustat. One supplier is listed for this generic product. Additional details are available on the daprodustat profile page.

When can BYFAVO (remimazolam besylate) generic drug versions launch in Australia?

Generic name: remimazolam besylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2027
Generic Entry Controlled by: Australia Patent 2,007,274,054
Patent Title: Short-acting benzodiazepine salts and their polymorphic forms

BYFAVO is a drug marketed by Acacia. There are eleven patents protecting this drug.

This drug has fifty-three patent family members in twenty-four countries. There has been litigation on patents covering BYFAVO

See drug price trends for BYFAVO.

The generic ingredient in BYFAVO is remimazolam besylate. One supplier is listed for this generic product. Additional details are available on the remimazolam besylate profile page.

When can TWIRLA (ethinyl estradiol; levonorgestrel) generic drug versions launch in Australia?

Generic name: ethinyl estradiol; levonorgestrel
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2027
Generic Entry Controlled by: Australia Patent 2,008,275,101
Patent Title: Dermal delivery device with in situ seal

Drug Price Trends for TWIRLA
TWIRLA is a drug marketed by Agile. There are three patents protecting this drug. Two tentatively approved generics are ready to enter the market.

This drug has nineteen patent family members in twelve countries.

See drug price trends for TWIRLA.

The generic ingredient in TWIRLA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this API. Twenty-three suppliers are listed for this generic product. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

When can TEPMETKO (tepotinib hydrochloride) generic drug versions launch in Australia?

Generic name: tepotinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Australia Patent 2,008,274,534
Patent Title: Pyrimidinyl pyridazinone derivates

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-six countries. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

The generic ingredient in TEPMETKO is tepotinib hydrochloride. One supplier is listed for this generic product. Additional details are available on the tepotinib hydrochloride profile page.

When can TEPMETKO (tepotinib hydrochloride) generic drug versions launch in Australia?

Generic name: tepotinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Australia Patent 2,008,274,670
Patent Title: Pyridazinone derivates

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-six countries. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

The generic ingredient in TEPMETKO is tepotinib hydrochloride. One supplier is listed for this generic product. Additional details are available on the tepotinib hydrochloride profile page.

When can KAZANO (alogliptin benzoate; metformin hydrochloride) generic drug versions launch in Australia?

Generic name: alogliptin benzoate; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 19, 2027
Generic Entry Controlled by: Australia Patent 2,008,276,842
Patent Title: Solid preparation comprising alogliptin and metformin hydrochloride

Drug Price Trends for KAZANO
KAZANO is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ninety patent family members in forty-one countries. There has been litigation on patents covering KAZANO

See drug price trends for KAZANO.

The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. There are ten drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the alogliptin benzoate; metformin hydrochloride profile page.

When can RASUVO (methotrexate) generic drug versions launch in Australia?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 20, 2027
Generic Entry Controlled by: Australia Patent 2,007,276,387

Drug Price Trends for RASUVO
RASUVO is a drug marketed by Medexus. There is one patent protecting this drug.

This drug has twenty-nine patent family members in twenty-one countries. There has been litigation on patents covering RASUVO

See drug price trends for RASUVO.

The generic ingredient in RASUVO is methotrexate. There are twenty drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the methotrexate profile page.

When can MULPLETA (lusutrombopag) generic drug versions launch in Australia?

Generic name: lusutrombopag
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 31, 2027
Generic Entry Controlled by: Australia Patent 2,008,283,357
Patent Title: Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity and intermediate thereof

MULPLETA is a drug marketed by Vancocin Italia. There are three patents protecting this drug.

This drug has forty-one patent family members in twenty countries.

See drug price trends for MULPLETA.

The generic ingredient in MULPLETA is lusutrombopag. Three suppliers are listed for this generic product. Additional details are available on the lusutrombopag profile page.

When can RELISTOR (methylnaltrexone bromide) generic drug versions launch in Australia?

Generic name: methylnaltrexone bromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Australia Patent 2,007,281,984

Drug Price Trends for RELISTOR
RELISTOR is a drug marketed by Salix Pharms and SalixThere are twelve patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has one hundred and twenty-four patent family members in thirty-six countries. There has been litigation on patents covering RELISTOR

See drug price trends for RELISTOR.

The generic ingredient in RELISTOR is methylnaltrexone bromide. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the methylnaltrexone bromide profile page.

When can WINLEVI (clascoterone) generic drug versions launch in Australia?

Generic name: clascoterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Australia Patent 2,008,285,784
Patent Title: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives

Drug Price Trends for WINLEVI
WINLEVI is a drug marketed by Sun Pharm. There are eight patents protecting this drug.

This drug has ninety-four patent family members in thirty countries. There has been litigation on patents covering WINLEVI

See drug price trends for WINLEVI.

The generic ingredient in WINLEVI is clascoterone. One supplier is listed for this generic product. Additional details are available on the clascoterone profile page.

When can INTRAROSA (prasterone) generic drug versions launch in Australia?

Generic name: prasterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2027
Generic Entry Controlled by: Australia Patent 2,008,286,651

Drug Price Trends for INTRAROSA
INTRAROSA is a drug marketed by Millicent. There are three patents protecting this drug.

This drug has fifty-nine patent family members in thirty-two countries. There has been litigation on patents covering INTRAROSA

See drug price trends for INTRAROSA.

The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the prasterone profile page.

When can LOCAMETZ (gallium ga-68 gozetotide) generic drug versions launch in Australia?

Generic name: gallium ga-68 gozetotide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 17, 2027
Generic Entry Controlled by: Australia Patent 2,008,289,108

LOCAMETZ is a drug marketed by Novartis. There are two patents protecting this drug.

This drug has fifty-five patent family members in sixteen countries.

See drug price trends for LOCAMETZ.

The generic ingredient in LOCAMETZ is gallium ga-68 gozetotide. There are sixteen drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the gallium ga-68 gozetotide profile page.

Last updated: May 12, 2026

Australia branded vs generic drug markets assessment and regulatory opportunities and challenges

Australia’s prescription market is moderate in size but structurally high-value for brand-to-generic transition planning because (1) government price controls drive rapid erosion once generics win listing and (2) patent and regulatory pathways can delay or accelerate entry depending on Therapeutic Goods Administration (TGA) and Pharmaceutical Benefits Scheme (PBS) submission quality, data strategy, and litigation posture. The practical opportunity set for branded sponsors and generic entrants clusters around: PBS listing leverage, TGA pathway selection (including bioequivalence and substitution-linked requirements), and jurisdiction-specific IP enforcement and challenge timing.


What does the Australian branded drug market look like by value, volume, and payer controls?

The Australian branded market is dominated by PBS-funded medicines. Branded products hold the larger share of PBS expenditure, while generics capture most volume share once listed and interchangeable at pharmacy.

Key structural features shaping branded economics

  • PBS reimbursement is the primary driver of payer uptake; patient copays are smaller than PBS pricing impact.
  • PBS listing decisions rely on clinical/economic assessments and comparators, creating a barrier for new entrants that can be navigated through differentiation, evidence packages, and robust economic arguments.
  • Price reductions and “downward price revision” mechanisms compress brand margins and can accelerate prescriber and pharmacist switching.

Market behavior that matters for IP timing

  • Patent expiry is not the only gate. Even with patent expiry, entry depends on PBS listing and the sponsor’s post-expiry pricing/contract position.
  • Brand exclusivity can be effectively extended through litigation stays, regulatory design choices, and additional protected indications or formulations.

How do generics perform in Australia: uptake speed, substitution, and PBS listing dynamics?

Australia is a high-performing generic market relative to many peers due to pharmacist substitution regimes and PBS listing breadth once approvals are obtained.

Adoption mechanics that determine revenue curves

  • Interchangeability and substitution at pharmacy increase generic throughput once PBS and regulatory requirements align.
  • “Launch after approval” does not always mean “launch after pricing.” PBS listing terms determine the practical addressable market and the speed of market share capture.

Generic business model constraints

  • Generic launch requires TGA approval plus PBS listing strategy.
  • Savings expectations from generics are shaped by benchmark pricing and ongoing PBS price reductions, which can compress net revenue quickly.

What are the main Australian regulatory bodies and pathways that govern generic entry and brand lifecycle?

Australia’s regulatory system divides between product authorization (TGA) and reimbursement (PBS). IP enforcement runs through Australian courts, and that interaction governs whether generics can launch commercially during disputes.

Therapeutic Goods Administration (TGA)

  • TGA authorization for generics typically depends on establishing comparable quality and bioequivalence, with reduced clinical burden versus brands.
  • Product-specific dossiers determine whether the pathway is acceptable without new clinical trials.

Pharmaceutical Benefits Scheme (PBS)

  • PBS listing is the market entry lever for scale.
  • Listing requires an evidence package addressing comparative effectiveness and cost-effectiveness relative to existing therapies.

IP and court enforcement

  • Australian patent litigation can create commercial barriers even after TGA approval.
  • Litigation timing influences whether a generic launch triggers immediate reimbursement or waits for resolution.

What patents protect branded medicines in Australia, and how do they map to generic entry risk?

Australia recognizes a layered patent landscape that typically includes:

  • substance (active ingredient) patents,
  • composition/formulation patents,
  • medical use (method of use) patents,
  • and sometimes manufacturing process patents.

Risk drivers for generic entrants

  • If any claims remain in force and read on the proposed product or use, that can create an injunction risk or settlement pressure.
  • Even when the active ingredient patent expires, formulation and indication-specific patents can extend exclusivity in practice via injunction leverage.

Risk drivers for branded sponsors

  • Overbroad or weak claims can be attacked during litigation.
  • If claims are narrow, generics may “design around” without needing full invalidation.

When does market exclusivity end in Australia: patent expiry vs PBS entry vs regulatory exclusivity?

Exclusivity in Australia is not a single date. The market end state is the earliest date that permits (1) regulatory authorization for the generic and (2) PBS-listed commercial launch without infringement exposure.

Practical “exclusivity end” timeline model

  • Patent expiry on the last relevant claim date.
  • Any post-expiry litigation outcomes that remove injunction risk.
  • PBS listing timeline: submission, evaluation, and administrative listing finalization.

Where brands can still defend revenue

  • Additional patents (new formulations, dosing regimens, or new indications) can keep at least one enforceable claim in play.
  • Brand can also use PBS listing strategy, including contractual or evidence-driven positioning.

What is the role of TGA bioequivalence and quality requirements for generics?

TGA requirements for generics focus on demonstrating comparable exposure and consistent pharmaceutical quality.

What matters for entry timelines

  • Bioequivalence study feasibility and design.
  • Formulation sameness or similarity to the reference product, which affects the likelihood of passing bioequivalence and quality scrutiny without bridging trials.

What drives compliance risk

  • Complex dosage forms or narrow therapeutic index products increase analytical and study burden.
  • Manufacturing controls and change management can impact batch comparability and audit outcomes.

How does PBS listing differ from US Orange Book logic, and what does that mean for patent strategy?

Australia does not use an Orange Book-style public patent register tied to reimbursement decisions. Instead, PBS listing is driven by comparative effectiveness and cost-effectiveness, while patent status controls infringement risk.

Strategic implications

  • Generic entry is a two-track problem:
    1. get TGA authorization,
    2. secure PBS listing and avoid patent infringement.
  • Branded sponsors must coordinate evidence packages with IP enforcement timing.
  • Generic challengers must coordinate litigation posture with PBS timelines.

What patent litigation affects generic entry in Australia?

In Australia, patent disputes can delay commercial launch through:

  • injunctions,
  • settlement agreements,
  • and court processes that extend beyond TGA authorization.

Where leverage concentrates

  • Claim scope and remaining enforceability.
  • Whether the generic product falls within claim construction.
  • The availability of design-around options that avoid infringement while keeping PBS eligibility and bioequivalence acceptability.

Deal dynamics

  • Settlement agreements frequently align with the earliest feasible launch date once patent risk falls below enforceable thresholds.
  • Courts and parties may factor the ability to avoid infringement by formulation changes.

What settlement structures are common in Australia, and how do they change launch economics?

Settlement terms vary, but the commercial pattern typically links:

  • a launch date,
  • restrictions on certain formulations or indications,
  • and payment structures that compensate for delayed entry.

Economics that shift under settlement

  • Earlier launch increases volume share, but often at lower net prices driven by PBS benchmarks.
  • Later launch may reduce the price erosion gap, but increases lost share in early phases.

Which branded segments face the highest genericization pressure in Australia?

Generic pressure concentrates where:

  • patent estates are relatively shallow,
  • formulations are straightforward to replicate,
  • and PBS comparators are well established.

Segments that commonly see rapid generic uptake

  • Many oral small-molecule categories with established dosing regimens.
  • Off-patent brands with mature clinical consensus and straightforward substitution.

Segments that resist genericization

  • Complex biologics where biosimilar pathways differ from generics.
  • Injectable or specialty formulations where bioequivalence and formulation similarity are harder.

How do biosimilars differ from generics in Australia: regulatory and IP barriers?

Biosimilars follow different evidentiary requirements than generics. The regulatory pathway and patent landscape function differently because biologics IP often includes:

  • molecule characterization,
  • formulation/process,
  • and method-of-use and manufacturing steps.

Key differences that affect opportunity

  • Biosimilar development is more expensive and slower than generic development.
  • IP landscapes often include more granular patents, increasing litigation and design-around complexity.

Market entry impact

  • Even after biosimilar approval, uptake depends on prescriber confidence, tendering, and PBS listing conditions.

What opportunities exist for branded sponsors in Australia beyond patent extension?

Branded sponsors can pursue several regulatory and commercial levers:

  • evidence upgrades to support PBS listing across new comparators or economic models,
  • formulation improvements that can trigger separate patent coverage and distinct product positioning,
  • and indication expansion that adds enforceable claims.

Where this works best

  • When the new formulation or dosing regimen remains clinically differentiated and meets PBS requirements.
  • When patents are drafted with clear claim scope aligned to the new product and intended use.

What opportunities exist for generic and biosimilar entrants in Australia despite IP?

Entry opportunities cluster where:

  • patents have narrow claim scope,
  • design-around paths exist that preserve bioequivalence and PBS comparability,
  • and litigation risk can be priced into launch plans.

Where speed matters

  • Generics that can align TGA approval and PBS listing timing can capture early volume before payer-driven share shifts intensify.

How does Australia PBS pricing pressure affect net revenue for both brands and generics?

PBS pricing drives predictable erosion after listing, especially once multiple alternatives exist.

For brands

  • Price reductions after generic entry can cause sharp net margin compression.
  • Brands may rely on:
    • supply contracts,
    • differentiated patient populations,
    • and additional protected indications.

For generics

  • Net revenue depends on:
    • benchmark-driven pricing,
    • uptake speed via substitution and prescriber behavior,
    • and competition from multiple generic entrants.

What are the main regulatory and compliance challenges for manufacturers seeking entry in Australia?

For generic entrants

  • Bioequivalence feasibility and analytical bridging for formulation differences.
  • Batch release controls and documentation strength.
  • Manufacturing audit outcomes that can delay approvals.

For branded sponsors

  • Evidence completeness and economic justification for PBS listing.
  • Managing lifecycle changes without creating regulatory scrutiny that triggers delays.
  • Coordinating additional indications with enforceable patent coverage.

How does Australia’s regulatory approach to interchangeability affect pharmacy-level adoption?

Pharmacy substitution and interchangeability regimes influence how quickly generics capture market share.

Key adoption outcomes

  • Earlier access to an interchangeable and PBS-listed alternative increases the share shift rate.
  • If multiple generics are available, price pressure can intensify quickly.

What geographic and jurisdictional factors matter for Australia IP enforcement?

Australia has its own patent enforcement system and court procedures. Many brands and generic firms treat Australia as:

  • a litigation venue for global patent strategies where claims are maintained locally,
  • and a reimbursement market with its own listing timeline.

Practical consequences

  • A global patent portfolio strategy must include:
    • local claim drafting and maintenance,
    • evidence of infringement alignment with proposed product use,
    • and litigation readiness aligned to PBS listing windows.

Key Takeaways

  • Australia’s branded market value is anchored by PBS reimbursement, which means payer listing strategy is as important as patent expiry.
  • Generic entry depends on dual gating: TGA authorization plus PBS listing and freedom-to-operate on enforceable Australian patents.
  • Patent estates frequently extend practical exclusivity through formulation and method-of-use claims even after active ingredient expiry.
  • Litigation and settlement timing can determine whether a generic can launch commercially immediately after regulatory approval.
  • Regulatory and compliance execution in bioequivalence, quality control, and documentation drives whether entry is fast or delayed, which is decisive in PBS-driven price erosion cycles.

FAQs

What is the fastest path to generic entry in Australia if patents are weak or narrow?

TGA bioequivalence approval followed by PBS submission aligned to the earliest listing date that avoids infringement risk from remaining claims.

How do PBS listing timelines affect Paragraph IV-style generic challenges in Australia?

Australia does not use the US Paragraph IV framework tied to a patent register; instead, generic entrants coordinate TGA readiness and PBS submission timing with Australian litigation risk.

Which product changes most often trigger delays in TGA approvals for generics?

Manufacturing process changes that affect critical quality attributes, formulation differences that require additional bridging, and documentation deficiencies uncovered during review.

How do settlement agreements typically influence the timing of generic launches?

They often establish an agreed launch date and can restrict certain product attributes or launch scopes, shifting market share and pricing outcomes.

How should brands design lifecycle strategy for Australia’s PBS environment?

Brands should align clinical and economic evidence with PBS requirements while maintaining enforceable patent coverage on formulation and use that maps to the intended product and patient positioning.


References

  1. Australian Government Department of Health and Aged Care. Pharmaceutical Benefits Scheme (PBS) program information.
  2. Therapeutic Goods Administration (TGA). TGA regulatory pathways and requirements for medicines and generics.
  3. IP Australia. Australian patent information and enforcement overview.
  4. Australian Government Federal Court of Australia and Federal Circuit and Family Court of Australia. Patent infringement and injunction case law resources.

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