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Last Updated: December 17, 2025

Australia: These 19 Drugs Face Patent Expirations and Generic Entry in 2025 - 2026

DrugPatentWatch® Estimated Loss of Exclusivity Dates in Australia

Generic Entry Dates in Other Countries

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.

Summary: Australia: These 19 Drugs Face Patent Expirations and Generic Entry in 2025 - 2026

Tradename Ingredient Estimated Entry Opportunity Date
EMBEDA morphine sulfate; naltrexone hydrochloride 2026-06-19
LASTACAFT alcaftadine 2026-03-31
AXUMIN fluciclovine f-18 2026-11-28
RASUVO methotrexate 2026-07-21
BRILINTA ticagrelor 2026-08-21
PRESTALIA amlodipine besylate; perindopril arginine 2026-02-28
>Tradename >Ingredient >Estimated Entry Opportunity Date

Details: Australia: These 19 Drugs Face Patent Expirations and Generic Entry in 2025 - 2026

When can EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 19, 2026
Generic Entry Controlled by: Australia Patent 2,013,257,508

EMBEDA is a drug marketed by Alpharma Pharms. There are nine patents protecting this drug and four Paragraph IV challenges.

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

See drug price trends for EMBEDA.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this API. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: March 31, 2026
Generic Entry Controlled by: Australia Patent 2,007,234,957

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

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: November 28, 2026
Generic Entry Controlled by: Australia Patent 2,006,319,987

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

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

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

When can RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: July 21, 2026
Generic Entry Controlled by: Australia Patent 2,007,276,387

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

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

See drug price trends for RASUVO.

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

When can BRILINTA (ticagrelor) generic drug versions launch?

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

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

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

See drug price trends for BRILINTA.

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

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

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity 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 TEKTURNA HCT (aliskiren hemifumarate; hydrochlorothiazide) generic drug versions launch?

Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 23, 2026
Generic Entry Controlled by: Australia Patent 2,007,263,261

Drug Price Trends for TEKTURNA HCT
TEKTURNA HCT is a drug marketed by Noden Pharma. There is one patent protecting this drug and one Paragraph IV challenge.

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

See drug price trends for TEKTURNA HCT.

The generic ingredient in TEKTURNA HCT is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this API. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity 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 eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six 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.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: June 16, 2026
Generic Entry Controlled by: Australia Patent 2,007,260,355

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

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

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can BIJUVA (estradiol; progesterone) generic drug versions launch?

Generic name: estradiol; progesterone
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: December 21, 2025
Generic Entry Controlled by: Australia Patent 366,507

Drug Price Trends for BIJUVA
BIJUVA is a drug marketed by Mayne Pharma. There are twenty-four patents protecting this drug.

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

See drug price trends for BIJUVA.

The generic ingredient in BIJUVA is estradiol; progesterone. There are seventy-five drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the estradiol; progesterone profile page.

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

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

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

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

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 Patent Expiration / Generic Entry Opportunity Date: January 18, 2026
Generic Entry Controlled by: Australia Patent 2,007,207,618

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 CRESEMBA (isavuconazonium sulfate) generic drug versions launch?

Generic name: isavuconazonium sulfate
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: September 25, 2026
Generic Entry Controlled by: Australia Patent 2,007,302,320

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

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

See drug price trends for CRESEMBA.

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

When can ZTALMY (ganaxolone) generic drug versions launch?

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

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

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

See drug price trends for ZTALMY.

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

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Patent Expiration / Generic Entry Opportunity Date: February 13, 2026
Generic Entry Controlled by: Australia Patent 2,006,341,592

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

This drug has forty-three 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 Patent Expiration / Generic Entry Opportunity Date: February 13, 2026
Generic Entry Controlled by: Australia Patent 2,013,216,632

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

This drug has forty-three 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 Patent Expiration / Generic Entry Opportunity Date: February 13, 2026
Generic Entry Controlled by: Australia Patent 2,016,262,644

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

This drug has forty-three 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 VYKAT XR (diazoxide choline) generic drug versions launch?

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

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

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

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

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