Last Updated: October 1, 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 47 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Generic Entry Dates in Other Countries

African Regional IP Organization (ARIPO) Argentina Austria Brazil Canada Chile China Colombia Costa Rica Croatia Cuba Cyprus Denmark Dominican Republic Ecuador Eurasian Patent Organization European Patent Office Finland France Georgia, Republic of Germany Guatemala Honduras Hong Kong Hungary Israel Italy Japan Jordan Lithuania Luxembourg Malaysia Mexico Montenegro Morocco Netherlands New Zealand Nicaragua Norway Panama Peru Philippines Poland Portugal Russian Federation San Marino Saudi Arabia Serbia Singapore Slovenia South Africa South Korea Spain Taiwan Tunisia Turkey Ukraine United Kingdom United States Uruguay
Preferred citation:
Friedman, Yali, "Australia: These 47 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 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. There has been litigation on patents covering TYMLOS

See drug price trends for TYMLOS.

The generic ingredient in TYMLOS is abaloparatide. 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. There has been litigation on patents covering INREBIC

See drug price trends for INREBIC.

The generic ingredient in INREBIC is fedratinib hydrochloride. 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. 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.

See drug price trends for PYLARIFY.

The generic ingredient in PYLARIFY is piflufolastat f-18. 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.

The generic ingredient in PYLARIFY TRUVU is piflufolastat f-18. 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 2,007,319,831

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. 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. There has been litigation on patents covering SOFDRA

The generic ingredient in SOFDRA is sofpironium bromide. 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. There has been litigation on patents covering AXUMIN

The generic ingredient in AXUMIN is fluciclovine f-18. 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. There has been litigation on patents covering ZTALMY

See drug price trends for ZTALMY.

The generic ingredient in ZTALMY is ganaxolone. 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.

See drug price trends for SIRTURO.

The generic ingredient in SIRTURO is bedaquiline fumarate. 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.

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. 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.

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. 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. There has been litigation on patents covering LETAIRIS

See drug price trends for LETAIRIS.

The generic ingredient in LETAIRIS is ambrisentan. Additional details are available on the ambrisentan 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.

The generic ingredient in VYKAT XR is diazoxide choline. 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.

See drug price trends for SEYSARA.

The generic ingredient in SEYSARA is sarecycline hydrochloride. 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

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. There has been litigation on patents covering EPSOLAY

See drug price trends for EPSOLAY.

The generic ingredient in EPSOLAY is benzoyl peroxide. 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. There has been litigation on patents covering OSENI

See drug price trends for OSENI.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. 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

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). 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

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP is pancrelipase (amylase;lipase;protease). 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. There has been litigation on patents covering PRESTALIA

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. 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. There has been litigation on patents covering SPRAVATO

See drug price trends for SPRAVATO.

The generic ingredient in SPRAVATO is esketamine hydrochloride. 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. 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 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

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. There has been litigation on patents covering INLYTA

See drug price trends for INLYTA.

The generic ingredient in INLYTA is axitinib. 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. 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. 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

PROMACTA is a drug marketed by Novartis. There is one patent protecting this drug and two Paragraph IV challenges. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. 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

PROMACTA is a drug marketed by Novartis. There is one patent protecting this drug and two Paragraph IV challenges. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. 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

PROMACTA is a drug marketed by Novartis. There is one patent protecting this drug and two Paragraph IV challenges. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. 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

PROMACTA is a drug marketed by Novartis. There is one patent protecting this drug and two Paragraph IV challenges. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. 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. There has been litigation on patents covering ICLUSIG

See drug price trends for ICLUSIG.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. 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. There has been litigation on patents covering VRAYLAR

See drug price trends for VRAYLAR.

The generic ingredient in VRAYLAR is cariprazine hydrochloride. 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

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

See drug price trends for TRELSTAR.

The generic ingredient in TRELSTAR is triptorelin pamoate. 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

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

The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. 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

JAKAFI is a drug marketed by Incyte Corp. There are nineteen patents protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering JAKAFI

See drug price trends for JAKAFI.

The generic ingredient in JAKAFI is ruxolitinib phosphate. 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. There has been litigation on patents covering KYBELLA

The generic ingredient in KYBELLA is deoxycholic acid. 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.

See drug price trends for JESDUVROQ.

The generic ingredient in JESDUVROQ is daprodustat. 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. There has been litigation on patents covering BYFAVO

See drug price trends for BYFAVO.

The generic ingredient in BYFAVO is remimazolam besylate. 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

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.

See drug price trends for TWIRLA.

The generic ingredient in TWIRLA is ethinyl estradiol; levonorgestrel. 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. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

The generic ingredient in TEPMETKO is tepotinib hydrochloride. 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. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

The generic ingredient in TEPMETKO is tepotinib hydrochloride. 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

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. There has been litigation on patents covering KAZANO

See drug price trends for KAZANO.

The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. 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. There has been litigation on patents covering RASUVO

See drug price trends for RASUVO.

The generic ingredient in RASUVO is methotrexate. 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

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

See drug price trends for MULPLETA.

The generic ingredient in MULPLETA is lusutrombopag. Additional details are available on the lusutrombopag 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 01, 2027
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.

The generic ingredient in SALONPAS is menthol; methyl salicylate. Additional details are available on the menthol; methyl salicylate 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

Drug Price Trends for WINLEVI
WINLEVI is a drug marketed by Sun Pharm. There are eight patents protecting this drug. There has been litigation on patents covering WINLEVI

See drug price trends for WINLEVI.

The generic ingredient in WINLEVI is clascoterone. 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
Patent Title: DHEA compositions for treating menopause

Drug Price Trends for INTRAROSA
INTRAROSA is a drug marketed by Millicent. There are three patents protecting this drug. There has been litigation on patents covering INTRAROSA

See drug price trends for INTRAROSA.

The generic ingredient in INTRAROSA is prasterone. Additional details are available on the prasterone profile page.

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

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 20, 2027
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. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

The generic ingredient in BRILINTA is ticagrelor. 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 20, 2027
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. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

The generic ingredient in BRILINTA is ticagrelor. Additional details are available on the ticagrelor profile page.

When can VIZAMYL (flutemetamol f-18) generic drug versions launch in Australia?

Generic name: flutemetamol f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 30, 2027
Generic Entry Controlled by: Australia Patent 2,008,292,201

VIZAMYL is a drug marketed by Ge Healthcare. There is one patent protecting this drug.

See drug price trends for VIZAMYL.

The generic ingredient in VIZAMYL is flutemetamol f-18. Additional details are available on the flutemetamol f-18 profile page.

When can PICATO (ingenol mebutate) generic drug versions launch in Australia?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 09, 2027
Generic Entry Controlled by: Australia Patent 2,006,325,244
Patent Title: Therapeutic compositions comprising ingenol-3-angelate

Drug Price Trends for PICATO
PICATO is a drug marketed by Leo Labs. There are twelve patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market. There has been litigation on patents covering PICATO

See drug price trends for PICATO.

The generic ingredient in PICATO is ingenol mebutate. Additional details are available on the ingenol mebutate profile page.

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

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 20, 2027
Generic Entry Controlled by: Australia Patent 2,010,210,018

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

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. Additional details are available on the ceritinib profile page.

When can ZEMDRI (plazomicin sulfate) generic drug versions launch in Australia?

Generic name: plazomicin sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 21, 2027
Generic Entry Controlled by: Australia Patent 2,008,326,297
Patent Title: Antibacterial aminoglycoside analogs

ZEMDRI is a drug marketed by Cipla Usa. There are four patents protecting this drug. There has been litigation on patents covering ZEMDRI

See drug price trends for ZEMDRI.

The generic ingredient in ZEMDRI is plazomicin sulfate. Additional details are available on the plazomicin sulfate profile page.

When can DUZALLO (allopurinol; lesinurad) generic drug versions launch in Australia?

Generic name: allopurinol; lesinurad
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 27, 2027
Generic Entry Controlled by: Australia Patent 2,008,329,673

Drug Price Trends for DUZALLO
DUZALLO is a drug marketed by Ironwood Pharms Inc. There are eight patents protecting this drug. There has been litigation on patents covering DUZALLO

See drug price trends for DUZALLO.

The generic ingredient in DUZALLO is allopurinol; lesinurad. Additional details are available on the allopurinol; lesinurad profile page.

When can DUZALLO (allopurinol; lesinurad) generic drug versions launch in Australia?

Generic name: allopurinol; lesinurad
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 27, 2027
Generic Entry Controlled by: Australia Patent 2,009,289,647

Drug Price Trends for DUZALLO
DUZALLO is a drug marketed by Ironwood Pharms Inc. There are eight patents protecting this drug. There has been litigation on patents covering DUZALLO

See drug price trends for DUZALLO.

The generic ingredient in DUZALLO is allopurinol; lesinurad. Additional details are available on the allopurinol; lesinurad profile page.

When can DUZALLO (allopurinol; lesinurad) generic drug versions launch in Australia?

Generic name: allopurinol; lesinurad
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 27, 2027
Generic Entry Controlled by: Australia Patent 2,012,203,172

Drug Price Trends for DUZALLO
DUZALLO is a drug marketed by Ironwood Pharms Inc. There are eight patents protecting this drug. There has been litigation on patents covering DUZALLO

See drug price trends for DUZALLO.

The generic ingredient in DUZALLO is allopurinol; lesinurad. Additional details are available on the allopurinol; lesinurad profile page.

When can ZURAMPIC (lesinurad) generic drug versions launch in Australia?

Generic name: lesinurad
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 27, 2027
Generic Entry Controlled by: Australia Patent 2,008,329,673

ZURAMPIC is a drug marketed by Ironwood Pharms Inc. There are eight patents protecting this drug. There has been litigation on patents covering ZURAMPIC

See drug price trends for ZURAMPIC.

The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.

When can ZURAMPIC (lesinurad) generic drug versions launch in Australia?

Generic name: lesinurad
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 27, 2027
Generic Entry Controlled by: Australia Patent 2,009,289,647

ZURAMPIC is a drug marketed by Ironwood Pharms Inc. There are eight patents protecting this drug. There has been litigation on patents covering ZURAMPIC

See drug price trends for ZURAMPIC.

The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.

When can ZURAMPIC (lesinurad) generic drug versions launch in Australia?

Generic name: lesinurad
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 27, 2027
Generic Entry Controlled by: Australia Patent 2,012,203,172

ZURAMPIC is a drug marketed by Ironwood Pharms Inc. There are eight patents protecting this drug. There has been litigation on patents covering ZURAMPIC

See drug price trends for ZURAMPIC.

The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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