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Last Updated: March 21, 2025

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 37 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Australia: These 37 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 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 REZUROCK (belumosudil mesylate) generic drug versions launch?

Generic name: belumosudil mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 25, 2025
Generic Entry Controlled by: Australia Patent 2,006,230,159
Patent Title: Pharmacokinetically improved compounds

REZUROCK is a drug marketed by Kadmon Pharms Llc. There are five patents protecting this drug.

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

See drug price trends for REZUROCK.

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

When can JATENZO (testosterone undecanoate) generic drug versions launch?

Generic name: testosterone undecanoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 15, 2025
Generic Entry Controlled by: Australia Patent 2,006,236,564
Patent Title: Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same

Drug Price Trends for JATENZO
JATENZO is a drug marketed by Tolmar. There are ten patents protecting this drug. One tentatively approved generic is ready to enter the market.

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

See drug price trends for JATENZO.

The generic ingredient in JATENZO is testosterone undecanoate. There are sixty-nine drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the testosterone undecanoate profile page.

When can JATENZO (testosterone undecanoate) generic drug versions launch?

Generic name: testosterone undecanoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 15, 2025
Generic Entry Controlled by: Australia Patent 2,011,201,422
Patent Title: Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same

Drug Price Trends for JATENZO
JATENZO is a drug marketed by Tolmar. There are ten patents protecting this drug. One tentatively approved generic is ready to enter the market.

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

See drug price trends for JATENZO.

The generic ingredient in JATENZO is testosterone undecanoate. There are sixty-nine drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the testosterone undecanoate profile page.

When can TYKERB (lapatinib ditosylate) generic drug versions launch?

Generic name: lapatinib ditosylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 19, 2025
Generic Entry Controlled by: Australia Patent 2,006,236,423
Patent Title: Pharmaceutical composition

TYKERB is a drug marketed by Novartis. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in twenty-six countries.

See drug price trends for TYKERB.

The generic ingredient in TYKERB is lapatinib ditosylate. There are seven drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the lapatinib ditosylate profile page.

When can XCOPRI (cenobamate) generic drug versions launch?

Generic name: cenobamate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 22, 2025
Generic Entry Controlled by: Australia Patent 2,006,237,798

Drug Price Trends for XCOPRI
XCOPRI is a drug marketed by Sk Life. There are two patents protecting this drug.

This drug has twenty-six patent family members in twenty countries.

See drug price trends for XCOPRI.

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

When can BELEODAQ (belinostat) generic drug versions launch?

Generic name: belinostat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Australia Patent 2,006,245,495
Patent Title: Pharmaceutical formulations of HDAC inhibitors

BELEODAQ is a drug marketed by Acrotech Biopharma. There are two patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for BELEODAQ.

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

When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Australia Patent 2,006,248,109
Patent Title: Diarylhydantoin compounds

XTANDI is a drug marketed by Astellas. There are five patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

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

See drug price trends for XTANDI.

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

When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Australia Patent 2,007,245,022
Patent Title: Diarylthiohydantoin compounds

XTANDI is a drug marketed by Astellas. There are five patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

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

See drug price trends for XTANDI.

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

When can TRACLEER (bosentan) generic drug versions launch?

Generic name: bosentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 17, 2025
Generic Entry Controlled by: Australia Patent 2,006,248,593
Patent Title: Dispersible bosertan tablet

TRACLEER is a drug marketed by Actelion. There are two patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has twenty-eight patent family members in twenty-three countries. There has been litigation on patents covering TRACLEER

See drug price trends for TRACLEER.

The generic ingredient in TRACLEER is bosentan. There are nineteen drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the bosentan profile page.

When can LATUDA (lurasidone hydrochloride) generic drug versions launch?

Generic name: lurasidone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 26, 2025
Generic Entry Controlled by: Australia Patent 2,006,250,340
Patent Title: Pharmaceutical composition

Drug Price Trends for LATUDA
LATUDA is a drug marketed by Sunovion Pharms Inc. There are seven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

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

See drug price trends for LATUDA.

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

When can VICTRELIS (boceprevir) generic drug versions launch?

Generic name: boceprevir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 02, 2025
Generic Entry Controlled by: Australia Patent 2,006,252,553

VICTRELIS is a drug marketed by Merck Sharp Dohme. There are two patents protecting this drug.

This drug has twenty-seven patent family members in seventeen countries.

The generic ingredient in VICTRELIS is boceprevir. Additional details are available on the boceprevir profile page.

When can OMONTYS (peginesatide acetate) generic drug versions launch?

Generic name: peginesatide acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 03, 2025
Generic Entry Controlled by: Australia Patent 2,006,255,081

OMONTYS is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.

This drug has twenty-seven patent family members in eighteen countries.

The generic ingredient in OMONTYS is peginesatide acetate. Additional details are available on the peginesatide acetate profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Australia Patent 2,006,261,788

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Australia Patent 2,008,285,660

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Australia Patent 2,008,320,915

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can BOSULIF (bosutinib monohydrate) generic drug versions launch?

Generic name: bosutinib monohydrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 01, 2025
Generic Entry Controlled by: Australia Patent 2,006,266,045

BOSULIF is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-one patent family members in thirty countries. There has been litigation on patents covering BOSULIF

See drug price trends for BOSULIF.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the bosutinib monohydrate profile page.

When can DUEXIS (famotidine; ibuprofen) generic drug versions launch?

Generic name: famotidine; ibuprofen
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 18, 2025
Generic Entry Controlled by: Australia Patent 2,006,269,894
Patent Title: Medicaments containing famotidine and ibuprofen and administration of same

Drug Price Trends for DUEXIS
DUEXIS is a drug marketed by Horizon. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in fifteen countries. There has been litigation on patents covering DUEXIS

See drug price trends for DUEXIS.

The generic ingredient in DUEXIS is famotidine; ibuprofen. There are eighteen drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the famotidine; ibuprofen profile page.

When can DUEXIS (famotidine; ibuprofen) generic drug versions launch?

Generic name: famotidine; ibuprofen
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 18, 2025
Generic Entry Controlled by: Australia Patent 2,007,275,360
Patent Title: Methods and medicaments for administration of ibuprofen

Drug Price Trends for DUEXIS
DUEXIS is a drug marketed by Horizon. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in fifteen countries. There has been litigation on patents covering DUEXIS

See drug price trends for DUEXIS.

The generic ingredient in DUEXIS is famotidine; ibuprofen. There are eighteen drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the famotidine; ibuprofen profile page.

When can APTIOM (eslicarbazepine acetate) generic drug versions launch?

Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Australia Patent 2,006,273,874
Patent Title: Asymmetric catalytic reduction of oxcarbazepine

Drug Price Trends for APTIOM
APTIOM is a drug marketed by Sumitomo Pharma Am. There are eleven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

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

See drug price trends for APTIOM.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate profile page.

When can OLYSIO (simeprevir sodium) generic drug versions launch?

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Australia Patent 2,006,274,865
Patent Title: Macrocyclic inhibitors of hepatitis C virus

OLYSIO is a drug marketed by Janssen Prods. There are nine patents protecting this drug.

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

See drug price trends for OLYSIO.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this API. Additional details are available on the simeprevir sodium profile page.

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

Generic name: benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 02, 2025
Generic Entry Controlled by: Australia Patent 2,006,274,541
Patent Title: Metal oxide coating of water insoluble ingredients

EPSOLAY is a drug marketed by Galderma Labs Lp. There are eleven patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has forty-five patent family members in thirteen countries.

See drug price trends for EPSOLAY.

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

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2025
Generic Entry Controlled by: Australia Patent 2,006,281,414
Patent Title: Controlled release pharmaceutical compositions for acid labile drugs

CREON is a drug marketed by

This drug has forty-five patent family members in thirteen countries. There has been litigation on patents covering CREON

See drug price trends for CREON.

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

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2025
Generic Entry Controlled by: Australia Patent 2,006,281,415
Patent Title: Pancreatin micropellet cores suitable for enteric coating

CREON is a drug marketed by

This drug has forty-five patent family members in thirteen countries. There has been litigation on patents covering CREON

See drug price trends for CREON.

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

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2025
Generic Entry Controlled by: Australia Patent 2,006,295,440
Patent Title: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients

ESBRIET is a drug marketed by Genentech Inc. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

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

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-two suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2025
Generic Entry Controlled by: Australia Patent 2,011,201,520
Patent Title: Capsule Formulation Of Pirfenidone And Pharmaceutically Acceptable Excipients

ESBRIET is a drug marketed by Genentech Inc. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

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

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-two suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2025
Generic Entry Controlled by: Australia Patent 2,013,201,986
Patent Title: Capsule Formulation Of Pirfenidone And Pharmaceutically Acceptable Excipients

ESBRIET is a drug marketed by Genentech Inc. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

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

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-two suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2025
Generic Entry Controlled by: Australia Patent 2,014,240,300
Patent Title: Capsule Formulation of Pirfenidone and Pharmaceutically Acceptable Excipients

ESBRIET is a drug marketed by Genentech Inc. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

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

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-two suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can LYRICA CR (pregabalin) generic drug versions launch?

Generic name: pregabalin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 02, 2025
Generic Entry Controlled by: Australia Patent 2,006,310,217
Patent Title: Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent

Drug Price Trends for LYRICA CR
LYRICA CR is a drug marketed by Upjohn. There are three patents protecting this drug and four Paragraph IV challenges. Six tentatively approved generics are ready to enter the market.

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

See drug price trends for LYRICA CR.

The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this API. Fifty-six suppliers are listed for this generic product. Additional details are available on the pregabalin profile page.

When can ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch?

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 09, 2025
Generic Entry Controlled by: Australia Patent 2,006,311,481
Patent Title: Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor

ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

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

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Nine suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2025
Generic Entry Controlled by: Australia Patent 2,006,318,349
Patent Title: Ganaxolone formulations and methods for the making and use thereof

ZTALMY is a drug marketed by Marinus. There are nine patents protecting this drug.

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

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 AXUMIN (fluciclovine f-18) generic drug versions launch?

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 29, 2025
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.

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 XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2025
Generic Entry Controlled by: Australia Patent 2,006,323,025
Patent Title: Polymorphs of a c-Met/HGFR inhibitor

XALKORI is a drug marketed by Pf Prism Cv. There are five patents protecting this drug.

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

See drug price trends for XALKORI.

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

When can BUNAVAIL (buprenorphine hydrochloride; naloxone hydrochloride) generic drug versions launch?

Generic name: buprenorphine hydrochloride; naloxone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 13, 2025
Generic Entry Controlled by: Australia Patent 2,006,326,377
Patent Title: Abuse resistant transmucosal drug delivery device

Drug Price Trends for BUNAVAIL
BUNAVAIL is a drug marketed by Bdsi. There are four patents protecting this drug and two Paragraph IV challenges. Two tentatively approved generics are ready to enter the market.

This drug has eighty-three patent family members in twenty-six countries. There has been litigation on patents covering BUNAVAIL

See drug price trends for BUNAVAIL.

The generic ingredient in BUNAVAIL is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

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

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 16, 2025
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.

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

See drug price trends for PICATO.

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this API. Additional details are available on the ingenol mebutate profile page.

When can KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2025
Generic Entry Controlled by: Australia Patent 2,006,330,759
Patent Title: Novel hydrogen sulfate salt

KOSELUGO is a drug marketed by Astrazeneca. There are five patents protecting this drug.

This drug has one hundred and ninety-eight patent family members in forty-four countries.

See drug price trends for KOSELUGO.

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

When can CAMCEVI KIT (leuprolide mesylate) generic drug versions launch?

Generic name: leuprolide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 18, 2026
Generic Entry Controlled by: Australia Patent 2,007,207,618
Patent Title: Pharmaceutical compositions with enhanced stability

CAMCEVI KIT is a drug marketed by Accord. There are five patents protecting this drug.

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

The generic ingredient in CAMCEVI KIT is leuprolide mesylate. There are twenty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the leuprolide mesylate profile page.

When can AMITIZA (lubiprostone) generic drug versions launch?

Generic name: lubiprostone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 24, 2026
Generic Entry Controlled by: Australia Patent 2,007,208,632
Patent Title: Soft-gelatin capsule formulation

Drug Price Trends for AMITIZA
AMITIZA is a drug marketed by Sucampo Pharma Llc. There are four patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for AMITIZA.

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

When can LEXISCAN (regadenoson) generic drug versions launch?

Generic name: regadenoson
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 03, 2026
Generic Entry Controlled by: Australia Patent 2,007,212,542
Patent Title: Process for preparing an A2A-Adenosine receptor agonist and its polymorphs

LEXISCAN is a drug marketed by Astellas. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eighteen countries. There has been litigation on patents covering LEXISCAN

See drug price trends for LEXISCAN.

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

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: Australia Patent 2,006,341,592
Patent Title: Intramuscular antiviral treatments

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

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

See drug price trends for RAPIVAB.

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

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: Australia Patent 2,007,215,156
Patent Title: Intravenous antiviral treatments

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

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

See drug price trends for RAPIVAB.

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

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: Australia Patent 2,013,216,632
Patent Title: INTRAVENOUS ANTIVIRAL TREATMENTS

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

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

See drug price trends for RAPIVAB.

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

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: Australia Patent 2,016,262,644
Patent Title: INTRAVENOUS ANTIVIRAL TREATMENTS

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

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

See drug price trends for RAPIVAB.

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

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

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 28, 2026
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 DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Australia Patent 2,007,227,569
Patent Title: Modified release formulations containing drug-ion exchange resin complexes

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are ten patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering DYANAVEL XR

See drug price trends for DYANAVEL XR.

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

When can TUZISTRA XR (chlorpheniramine polistirex; codeine polistirex) generic drug versions launch?

Generic name: chlorpheniramine polistirex; codeine polistirex
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Australia Patent 2,007,227,569
Patent Title: Modified release formulations containing drug-ion exchange resin complexes

TUZISTRA XR is a drug marketed by Tris Pharma Inc. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering TUZISTRA XR

See drug price trends for TUZISTRA XR.

The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this API. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.

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

Generic name: esketamine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 22, 2026
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-one patent family members in twenty-four countries.

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 AMYVID (florbetapir f-18) generic drug versions launch?

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: Australia Patent 2,007,243,712
Patent Title: Styrylpyridine derivatives and their use for binding and imaging amyloid plaques

AMYVID is a drug marketed by Avid Radiopharms Inc. There are two patents protecting this drug.

This drug has fifty-one patent family members in thirty-three countries.

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

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Australia Patent 2,007,234,957
Patent Title: Ocular allergy treatments

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

This drug has forty-six patent family members in thirty countries. There has been litigation on patents covering LASTACAFT

See drug price trends for LASTACAFT.

The generic ingredient in LASTACAFT is alcaftadine. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the alcaftadine profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Australia Patent 2,007,247,193

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are ten patents protecting this drug and one Paragraph IV challenge. Six tentatively approved generics are ready to enter the market.

This drug has four hundred and sixty-two patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

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

Market Analysis and Financial Projection

The Australian pharmaceutical market is a dynamic landscape shaped by evolving regulatory frameworks, shifting demographics, and growing demand for cost-effective therapies. Below is an analysis of the branded and generic drug markets, along with regulatory opportunities and challenges.


Market Overview

  • Branded drugs: Dominated by prescription medications (largest market share), fueled by an aging population (16% aged 65+ in 2021) and chronic diseases like cancer and cardiovascular conditions[1][4]. Key players include Pfizer, AbbVie, and AstraZeneca.
  • Generic drugs: Projected to grow at 7.9% CAGR (2024–2031), reaching USD 9.56B, driven by cost containment policies and patent expirations[14]. Generic entry reduces drug prices by ~31% initially[2].
Aspect Branded Drugs Generic Drugs
Market Size (2030) USD 19.01B (6.25% CAGR from 2025)[1] USD 9.56B (7.9% CAGR from 2024)[14]
Growth Drivers Aging population, chronic diseases[1][16] Cost savings, government agreements[5][14]
Key Players Pfizer, Amgen, Eli Lilly Lupin, Cipla, Sandoz

Regulatory Opportunities

  1. Streamlined Pathways:

    • Five TGA approval routes, including priority review and provisional pathways, accelerate access for innovative therapies[3][4].
    • Proposed use of international reference products for bioequivalence studies could reduce registration barriers for generics[10][13].
  2. International Harmonization:

    • TGA aligns with EU/U.S. standards, enabling joint submissions and faster approvals[3][17]. For example, UDI regulations (voluntary in 2025) mirror EU frameworks[17].
  3. Government Initiatives:

    • Pharmaceutical Benefits Scheme (PBS) listings expanded in 2024, covering 90% of prescriptions[6][16].
    • AUD 200M investment by the Generic and Biosimilar Medicines Association (GBMA) to prevent shortages[14].
  4. Biosimilar Adoption:

    • Australia’s first trastuzumab biosimilar (Herzuma) approved in 2018, with policies favoring biosimilar prescribing[18].

Regulatory Challenges

  1. Price Pressures:

    • PBS expenditure growth slowed to 5.9% YoY in 2023–24 due to cost-containment measures, including frozen patient co-payments[15].
    • Mandatory price reductions post-generic entry squeeze margins for branded drugs[2][5].
  2. Delayed Market Access:

    • 466-day average delay from TGA approval to PBS reimbursement[15]. Infrequent PBAC meetings and stringent cost-effectiveness requirements stall listings[15].
  3. Complex Compliance:

    • TGA mandates Australia-specific clinical data, even for drugs approved in the U.S./EU, increasing costs[11].
    • High registration fees (e.g., generics approval takes 11 months, costing ~USD 50K)[9].
  4. Patent Cliffs & Competition:

    • Major therapies like Saxenda® (liraglutide) face generics competition post-2025 patent expiry[19].
    • Branded drugs lose ~35% market share within 2 years of generic entry[2][6].

Strategic Recommendations

  • For Branded Drugs:
    Focus on niche therapies (e.g., oncology, rare diseases) and leverage priority review pathways[3].
  • For Generics:
    Target therapeutic gaps (e.g., epilepsy, diabetes) and collaborate with Indian manufacturers under bilateral agreements[1][6].

"The TGA’s harmonization efforts aim to balance innovation and affordability, but structural reforms are needed to address delays." [3][17]


Future Outlook

  • 2025–2030: Expect ~20 new generics annually, driven by patent expirations and PBS reforms[14][19].
  • Policy Impact: Health Technology Assessment Review (2024) aims to halve reimbursement delays through streamlined PBAC processes[15].

Australia’s pharmaceutical sector remains a high-potential market, but stakeholders must navigate pricing pressures and regulatory complexity to capitalize on growth opportunities.

References

  1. https://www.mordorintelligence.com/industry-reports/australia-pharmaceutical-market
  2. https://pubmed.ncbi.nlm.nih.gov/38925096/
  3. https://www.pharmalex.com/thought-leadership/blogs/amid-global-regulatory-complexity-australia-shines-a-light-on-convergence-and-collaboration/
  4. https://credevo.com/articles/2022/12/25/how-to-register-a-prescription-medicine-in-australia/
  5. https://pmc.ncbi.nlm.nih.gov/articles/PMC1894637/
  6. https://pharmexcil.com/uploads/countryreports/Australia-_Regulatory_Market_Profile.pdf
  7. https://australianprescriber.tg.org.au/articles/the-australian-drug-regulatory-system.html
  8. https://www.freyrsolutions.com/what-is-the-tga-in-australia
  9. https://jpionline.org/article/32218/
  10. https://www.gabionline.net/policies-legislation/Australia-plans-reform-of-its-generics-authorization-process
  11. https://www.spglobal.com/marketintelligence/en/mi/country-industry-forecasting.html?id=10659106300
  12. https://www.tga.gov.au/products/medicines/non-prescription-medicines/assessed-listed-medicines
  13. https://www.tga.gov.au/sites/default/files/consultation-reforms-generic-medicine-market-authorisation-process.pdf
  14. https://www.marketsandata.com/industry-reports/australia-generic-drugs-market
  15. https://www.fitchsolutions.com/bmi/pharmaceuticals/australias-pharmaceutical-market-forecast-revised-down-due-medicine-pricing-challenges-29-01-2025
  16. https://www.expertmarketresearch.com.au/reports/australia-pharmaceutical-market
  17. https://www.emergobyul.com/news/review-recent-regulatory-amendments-australia-international-harmonization-and-reliance
  18. https://www.centerforbiosimilars.com/view/eye-on-pharma-australia-approves-its-first-trastuzumab-biosimilar
  19. https://www.pearceip.law/2025/03/12/approval-alert-ciplas-generic-liraglutide-second-to-be-approved-in-australia/

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