Last Updated: May 11, 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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New Zealand: These 39 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

The content of this page is licensed under a Creative Commons Attribution 4.0 International License. Creative Commons License

Preferred citation:
Friedman, Yali, "New Zealand: These 39 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.

Market Analysis and Financial Projection

Last updated: May 11, 2026

Branded Drug Loss-of-Exclusivity (LoE) Dates for Q2 2026 in New Zealand

Branded drug loss-of-exclusivity dates for Q2 2026 in New Zealand are not available from the referenced source. The material at “/p/expiring-drug-patents-generic-entry/index.php” is not accessible in this environment, so no compliant, source-backed LoE dataset can be extracted for the requested quarter.

What LoE events in Q2 2026 (NZ) can be listed?

None can be listed from the specified source, because the source content cannot be retrieved here.

Which branded products have LoE dates in Q2 2026 (NZ)?

No branded products can be identified from the specified source for:

  • Q2 2026 (calendar quarter: 1 Apr 2026 to 30 Jun 2026)

What generic-entry timelines can be mapped to branded LoE for Q2 2026 (NZ)?

None can be mapped, because the generic-entry tables or patent-expiry schedules needed to compute or verify branded LoE dates cannot be accessed.

What date fields are typically required to confirm LoE in Q2 2026 (NZ)?

A complete branded LoE entry normally requires at least:

  • branded product name
  • NZ jurisdiction mapping
  • expiry basis (patent/SPC/other regulatory exclusivity)
  • effective LoE date (or first day exclusivity no longer blocks generic entry)
  • generic entry trigger basis (e.g., filing/approval-linked)

Those fields are not retrievable from the specified page in this environment, so no table can be produced without fabricating data.

Loss-of-exclusivity date table (Q2 2026, NZ)

Branded product LoE date (NZ) Quarter Generic-entry basis Source
Q2 2026

Key Takeaways

  • No branded drug LoE dates for Q2 2026 in New Zealand can be produced from the referenced page because the page content is not accessible here.
  • A LoE table requires the source’s underlying expiry and generic-entry schedule data, which cannot be extracted in this environment.

FAQs

  1. What is Q2 2026 for New Zealand date screening?
    1 Apr 2026 to 30 Jun 2026.

  2. What counts as “loss of exclusivity” for branded drugs?
    The date when an identified exclusivity right (typically patent and/or regulatory exclusivity) no longer blocks generic entry.

  3. What is “generic-entry” mapping in LoE datasets?
    Linking the exclusivity end date to the earliest date a generic can enter, based on the dataset’s stated regulatory or procedural trigger.

  4. Why can’t branded LoE dates be listed from the requested page?
    The referenced page content cannot be accessed in this environment, so no verified extraction is possible.

  5. What’s the minimum data needed to build a compliant LoE table?
    Product name, NZ jurisdiction mapping, exclusivity expiry basis, and the specific LoE date used by the source.

References

  1. Site page: “/p/expiring-drug-patents-generic-entry/index.php” (content not accessible in this environment).

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

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: New Zealand Patent 573,757
Patent Title: Coated multilayer oral dosage forms of naltrexone hydrochloride

EMBEDA is a drug marketed by Alpharma Pharms. There are seven 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 XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: New Zealand Patent 572,798
Patent Title: PROCESS FOR THE PRODUCTION OF SAFINAMIDE AND RALFINAMIDE

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

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

See drug price trends for XADAGO.

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

When can XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: New Zealand Patent 595,737
Patent Title: PROCESS FOR THE PRODUCTION OF SAFINAMIDE AND RALFINAMIDE

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

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

See drug price trends for XADAGO.

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

When can JESDUVROQ (daprodustat) generic drug versions launch?

Generic name: daprodustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: New Zealand Patent 573,698
Patent Title: Barbituric and thiobarbituric amino acid derivatives as prolyl hydroxylase inhibitors

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

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

See drug price trends for JESDUVROQ.

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

When can TEKTURNA HCT (aliskiren hemifumarate; hydrochlorothiazide) generic drug versions launch?

Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: New Zealand Patent 572,937
Patent Title: Solid oral dosage form of Aliskiren and hydrochlorothiazide which comprise a filler which is a mixture of wheat starch and lactose

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 EXFORGE HCT (amlodipine besylate; hydrochlorothiazide; valsartan) generic drug versions launch?

Generic name: amlodipine besylate; hydrochlorothiazide; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2026
Generic Entry Controlled by: New Zealand Patent 573,295

Drug Price Trends for EXFORGE HCT
EXFORGE HCT is a drug marketed by Novartis.

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

See drug price trends for EXFORGE HCT.

The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 574,346

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

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

See drug price trends for BYDUREON.

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

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 589,190

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

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

See drug price trends for BYDUREON.

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

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 589,195

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

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

See drug price trends for BYDUREON.

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

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 589,202

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

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

See drug price trends for BYDUREON.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 574,346

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

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 589,190

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

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 589,195

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

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 589,202

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

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

See drug price trends for FARXIGA.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 574,346

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 589,190

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 589,195

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: New Zealand Patent 589,202

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

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

See drug price trends for QTERN.

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

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

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: New Zealand Patent 573,060
Patent Title: MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

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

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

See drug price trends for EVOTAZ.

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

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

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: New Zealand Patent 579,802
Patent Title: Compounds for improving the efficacy of other drugs

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

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

See drug price trends for EVOTAZ.

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

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

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: New Zealand Patent 612,093
Patent Title: Modulators of pharmacokinetic properties of therapeutics

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

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

See drug price trends for EVOTAZ.

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

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

Generic name: menthol; methyl salicylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: New Zealand Patent 572,705
Patent Title: ADHESIVE PREPARATION containing methyl salicylate

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

This drug has twenty patent family members in sixteen countries.

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

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

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: New Zealand Patent 574,805
Patent Title: HEPATITIS C VIRUS INHIBITORS

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

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

See drug price trends for DAKLINZA.

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

When can 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, 2026
Generic Entry Controlled by: New Zealand Patent 565,959
Patent Title: Pancreatin micropellet cores suitable for enteric coating

CREON is a drug marketed by

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

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. 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, 2026
Generic Entry Controlled by: New Zealand Patent 565,960
Patent Title: Controlled release pharmaceutical compositions for acid labile drugs

CREON is a drug marketed by

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

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. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can BRILINTA (ticagrelor) generic drug versions launch?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: New Zealand Patent 574,514
Patent Title: Compositions, suitable for oral administration, comprising a triazolo [4, 5-d]pyrimidin derivate

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

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

See drug price trends for BRILINTA.

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

When can BRILINTA (ticagrelor) generic drug versions launch?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: New Zealand Patent 596,700
Patent Title: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4,5-D]PYRIMIDIN DERIVATE

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

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

See drug price trends for BRILINTA.

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

When can OPSUMIT (macitentan) generic drug versions launch?

Generic name: macitentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: New Zealand Patent 575,702
Patent Title: THERAPEUTIC COMPOSITIONS COMPRISING A SPECIFIC ENDOTHELIN RECEPTOR ANTAGONIST AND A PDE5 INHIBITOR

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

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

See drug price trends for OPSUMIT.

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

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

Generic name: seladelpar lysine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 13, 2026
Generic Entry Controlled by: New Zealand Patent 566,504
Patent Title: Novel lysine salts of 4-(phenoxyalkyl) thio)-phenoxyacetic acid derivatives

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

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

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

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: New Zealand Patent 565,957
Patent Title: Capsule formulation of pirfenidone and pharmaceutically acceptable excipients

ESBRIET is a drug marketed by Legacy Pharma. 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-six 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-four 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, 2026
Generic Entry Controlled by: New Zealand Patent 600,129
Patent Title: Capsule formation of pirfenidone and pharmaceutically acceptable excipients

ESBRIET is a drug marketed by Legacy Pharma. 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-six 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-four suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can TYMLOS (abaloparatide) generic drug versions launch?

Generic name: abaloparatide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: New Zealand Patent 576,682
Patent Title: METHOD OF DRUG DELIVERY FOR BONE ANABOLIC PROTEIN PARATHYROID HORMONE-RELATED PROTEIN (PTHrP)

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

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

See drug price trends for TYMLOS.

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

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

Generic name: fedratinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: New Zealand Patent 592,990

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

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

See drug price trends for INREBIC.

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

When can BEVYXXA (betrixaban) generic drug versions launch?

Generic name: betrixaban
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 07, 2026
Generic Entry Controlled by: New Zealand Patent 567,992
Patent Title: Pharmaceutical salts and polymorphs of N-(5-chloro-2-pyridinyl)-2-[[4-[(dimethylamino)iminomethyl]benzoyl]amino]-5-methoxy-benzamide, a factor Xa inhibitor

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

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

See drug price trends for BEVYXXA.

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

When can BEVYXXA (betrixaban) generic drug versions launch?

Generic name: betrixaban
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 07, 2026
Generic Entry Controlled by: New Zealand Patent 592,533
Patent Title: METHOD FOR THE PREPARATION OF N-(5-CHLORO-2-PYRIDINYL)-2-[[4-[(DIMETHYLAMINO) IMINOMETHYL] BENZOYL] AMINO]-5-METHOXY-BENZAMIDE, A FACTOR Xa INHIBITOR

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

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

See drug price trends for BEVYXXA.

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

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

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: New Zealand Patent 594,006
Patent Title: Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor

Drug Price Trends for ENTRESTO SPRINKLE
ENTRESTO SPRINKLE is a drug marketed by Novartis. There are three patents protecting this drug.

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

See drug price trends for ENTRESTO SPRINKLE.

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan 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 08, 2026
Generic Entry Controlled by: New Zealand Patent 600,626
Patent Title: Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor

Drug Price Trends for ENTRESTO SPRINKLE
ENTRESTO SPRINKLE is a drug marketed by Novartis. There are three patents protecting this drug.

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

See drug price trends for ENTRESTO SPRINKLE.

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

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

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: New Zealand Patent 577,107
Patent Title: Synthetic peptide amide ligands of the kappa opiod receptor

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

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

See drug price trends for KORSUVA.

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

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

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: New Zealand Patent 577,108
Patent Title: Synthetic peptide amides and dimers thereof of the kappa opioid receptor

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

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

See drug price trends for KORSUVA.

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

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

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: New Zealand Patent 576,485

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

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

See drug price trends for SIRTURO.

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

When can ZYKADIA (ceritinib) generic drug versions launch?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: New Zealand Patent 577,197

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

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

See drug price trends for ZYKADIA.

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

When can ZYKADIA (ceritinib) generic drug versions launch?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: New Zealand Patent 590,601
Patent Title: PYRIMIDINE COMPOUNDS ESPECIALLY 4-PHENYLAMINO-2-ARYLAMINO-PYRIMIDINE DERIVATIVES AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS

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

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

See drug price trends for ZYKADIA.

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

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

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: New Zealand Patent 577,004
Patent Title: 4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE

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

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

See drug price trends for XERMELO.

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

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

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 18, 2026
Generic Entry Controlled by: New Zealand Patent 569,197
Patent Title: Therapeutic compositions comprising ingenol 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 OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: New Zealand Patent 579,008
Patent Title: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE

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

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

See drug price trends for OSENI.

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

When can LEXISCAN (regadenoson) generic drug versions launch?

Generic name: regadenoson
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 02, 2027
Generic Entry Controlled by: New Zealand Patent 570,239
Patent Title: Preparation of (1-{ 9-[(4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopurin-2-yl} pyrazol-4-yl)-N-methylcarboxamide monohydrate

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. Seventeen suppliers are listed for this generic product. Additional details are available on the regadenoson profile page.

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: New Zealand Patent 579,047
Patent Title: STABLE DIGESTIVE ENZYME COMPOSITIONS

PANCREAZE is a drug marketed by

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

See drug price trends for PANCREAZE.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: New Zealand Patent 598,477
Patent Title: STABLE DIGESTIVE ENZYME COMPOSITIONS

PANCREAZE is a drug marketed by

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

See drug price trends for PANCREAZE.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: New Zealand Patent 579,047
Patent Title: STABLE DIGESTIVE ENZYME COMPOSITIONS

ZENPEP is a drug marketed by

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

See drug price trends for ZENPEP.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: New Zealand Patent 598,477
Patent Title: STABLE DIGESTIVE ENZYME COMPOSITIONS

ZENPEP is a drug marketed by

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

See drug price trends for ZENPEP.

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

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

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: New Zealand Patent 579,011

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

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

See drug price trends for XENLETA.

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

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

Generic name: azilsartan kamedoxomil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 28, 2027
Generic Entry Controlled by: New Zealand Patent 579,851
Patent Title: SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT

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

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

See drug price trends for EDARBI.

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

When can SYMDEKO (COPACKAGED) (ivacaftor; ivacaftor, tezacaftor) generic drug versions launch?

Generic name: ivacaftor; ivacaftor, tezacaftor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 09, 2027
Generic Entry Controlled by: New Zealand Patent 571,803
Patent Title: Amide indole derivatives as modulators of ATP-binding cassette transporters

SYMDEKO (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-six patents protecting this drug.

This drug has four hundred and twenty-eight patent family members in forty-one countries. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

When can SYMDEKO (COPACKAGED) (ivacaftor; ivacaftor, tezacaftor) generic drug versions launch?

Generic name: ivacaftor; ivacaftor, tezacaftor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 09, 2027
Generic Entry Controlled by: New Zealand Patent 596,889
Patent Title: Use of amide indole derivatives as modulators of ATP-binding cassette transporters

SYMDEKO (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-six patents protecting this drug.

This drug has four hundred and twenty-eight patent family members in forty-one countries. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

When can SYMDEKO (COPACKAGED) (ivacaftor; ivacaftor, tezacaftor) generic drug versions launch?

Generic name: ivacaftor; ivacaftor, tezacaftor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 09, 2027
Generic Entry Controlled by: New Zealand Patent 611,485
Patent Title: Modulators of atp-binding cassette transporters

SYMDEKO (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-six patents protecting this drug.

This drug has four hundred and twenty-eight patent family members in forty-one countries. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

When can SIGNIFOR LAR (pasireotide pamoate) generic drug versions launch?

Generic name: pasireotide pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 24, 2027
Generic Entry Controlled by: New Zealand Patent 580,589
Patent Title: AN EXTENDED-RELEASE COMPOSITION COMPRISING A SOMATOSTATIN DERIVATIVE IN MICROPARTICLES

SIGNIFOR LAR is a drug marketed by Recordati Rare. There are three patents protecting this drug.

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

See drug price trends for SIGNIFOR LAR.

The generic ingredient in SIGNIFOR LAR is pasireotide pamoate. One supplier is listed for this generic product. Additional details are available on the pasireotide pamoate profile page.

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

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: New Zealand Patent 582,423
Patent Title: SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES COMPRISING PLGA, LHRH AND LACTIC ACID

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

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

See drug price trends for TRELSTAR.

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

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

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: New Zealand Patent 582,423
Patent Title: SLOW RELEASE PHARMACEUTICAL COMPOSITION MADE OF MICROPARTICLES COMPRISING PLGA, LHRH AND LACTIC ACID

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

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

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

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

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2027
Generic Entry Controlled by: New Zealand Patent 572,986
Patent Title: 1- [2- (2, 4-DIMETHYLPHENYLSULFANYL) -PHENYL] PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF COGNITIVE IMPAIRMENT

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. Three 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 KYBELLA (deoxycholic acid) generic drug versions launch?

Generic name: deoxycholic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: New Zealand Patent 581,081
Patent Title: SYNTHETIC DEOXYCHOLIC ACID (DCA) OR AN ESTER, HYDROXAMALE, OR HYDROXYAMIDE THEREOF

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

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

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

When can OJEMDA (tovorafenib) generic drug versions launch?

Generic name: tovorafenib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 29, 2027
Generic Entry Controlled by: New Zealand Patent 582,352

OJEMDA is a drug marketed by Day One Biopharms. There are two patents protecting this drug.

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

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

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

Generic name: ethinyl estradiol; levonorgestrel
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2027
Generic Entry Controlled by: New Zealand Patent 582,565
Patent Title: DERMAL DELIVERY DEVICE WITH IN SITU SEAL

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

This drug has nineteen patent family members in twelve countries.

See drug price trends for TWIRLA.

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

New Zealand Branded and Generic Drug Markets Assessment: Regulatory Opportunities and Challenges

Last updated: April 25, 2026

How big are New Zealand’s branded and generic drug markets?

New Zealand’s outpatient medicines market is dominated by subsidised products under the Pharmaceutical Management Agency (PHARMAC) framework. PHARMAC sets the subsidy environment through medicine assessments, listings, and price negotiations, while the market for non-subsidised products remains smaller and more specialist. Brand and generic competition is shaped less by retail pricing alone and more by PHARMAC listing decisions, tendering, reference pricing, and interchangeability rules.

Market structure and decision levers

Lever What PHARMAC controls Market impact
Subsidy listing Whether a medicine is funded and under what conditions Sets baseline demand for subsidised products
Price negotiation / tendering Prices after market entry or after competitive procurement Drives generic uptake and branded price compression
Interchangeability rules What can be substituted at the pharmacy level (bioequivalence and product categories) Changes switching behaviour independent of prescriber preference
Delisting and restricted supply Removal or narrowing of funded indications or products Shifts volume to alternatives, often generics
Uptake requirements for new entrants Conditions attached to funded listings Controls speed of generic substitution

What is the regulatory structure governing branded vs generic access?

Key regulators and roles

Institution Role in medicines access Why it matters for branded vs generic
Medsafe Regulates medicines safety, quality, and approves medicines for marketing Impacts entry timing and data package requirements
Pharmacovigilance (incl. MAHs and reporting obligations) Monitors safety and manages risk Drives post-market obligations that can increase cost for all entrants
PHARMAC Controls public subsidy listing decisions Creates the most material commercial differentiation between brands and generics
NZ Formulary / prescribing and pharmacy systems Implements funded product information and substitution processes Determines switching and dispensing outcomes

How do generic entry and substitution play out in practice?

Generic entry in New Zealand is a two-track problem: regulatory authorisation to market and economic access to the subsidised channel.

Regulatory pathway to marketing authorisation

Generic medicines typically rely on abbreviated evidence approaches where the active ingredient and formulation are demonstrated to meet equivalence requirements for safety/efficacy. The commercial bottleneck is usually not approval but PHARMAC funding eligibility, tender design, and interchangeability.

Commercial pathways into subsidised care

Pathway Typical trigger Competitive effect
Tender-based procurement Brand is supplanted by a lower-cost equivalent through procurement Fast price and volume shift
Reference pricing / subsidy restructuring PHARMAC reduces subsidy to align with lower-cost options Forces branded downgrades in net revenue
Interchangeability Pharmacy can dispense an alternative product within defined criteria Increases switching velocity
Delisting of older options Brand loses funded status after new comparator economics Volume exits the subsidised channel

Where do PHARMAC decisions create the biggest opportunity for generics?

Generics win when they align with PHARMAC’s cost-minimisation and supply-continuity goals.

Opportunity pockets

  1. Mature off-patent portfolios with established demand

    • High volumes and clear clinical positioning for first-line therapy
    • PHARMAC’s procurement and interchangeability tools can move share quickly
  2. Therapeutic areas with recurring tender cycles

    • Repeatable procurement processes create a predictable route to funded listing
  3. Products facing branded net price compression

    • When PHARMAC renegotiates or re-tenders, generics can secure economics that brands cannot
  4. At-risk supply and procurement reliability

    • PHARMAC may factor supply certainty into procurement and listing continuity

What constraints shape branded strategy in New Zealand?

Brand economics are structurally exposed to funding decisions

Branded products generally face:

  • Subsidy-driven demand: most substantial outpatient demand flows through PHARMAC listing.
  • Comparative pricing pressure: even when a brand retains a listing, lower-cost equivalents can be introduced through tendering and interchangeability.
  • Time-based risk: loss of funding after tender cycles or restricted listing changes can reduce forecastable revenue.

Brand-specific risk profile

Risk type Where it shows up Mechanism
Price compression Post-tender or re-negotiation Subsidy moves toward lowest funded options
Volume erosion Interchangeability and switching Pharmacy-level substitution reduces brand capture
Loss of indication specificity Restricted benefit decisions Narrower funded criteria shift demand to alternatives
Delisting Funding review outcomes Exit the subsidised outpatient market

Which New Zealand regulatory processes most affect timelines and cost?

Pre-market approval and evidence requirements

Medsafe approval timelines depend on the completeness of quality/safety/efficacy dossiers and whether an abridged pathway can be used.

Post-market obligations

  • Pharmacovigilance reporting requirements and safety updates apply across products.
  • Variation management and periodic updates can drive ongoing compliance cost.

Implications by product type

Product type Time-critical step Typical cost pressure
Branded originator Differentiation and evidence support for use and safety profile Dossier build and lifecycle updates
Generic Equivalence package readiness and substitution fit Regulatory package + rapid funding strategy
Biosimilar (if applicable) Manufacturing comparability and robust similarity evidence High evidence burden even for “follow-on” biologics

What are the most material regulatory opportunities for branded firms?

Lifecycle differentiation that survives the subsidy lens

Branded firms can maintain commercial traction when they deliver:

  • clear incremental clinical value, including improved tolerability, usability, or outcomes versus competitors
  • strong safety signals management and risk mitigation proposals
  • evidence aligned to funded-use protocols (what clinicians and PHARMAC actually fund)

Regulatory opportunities through product evolution

Opportunity lever How it can work Commercial outcome
New formulation or dosing option Better adherence or reduced adverse events Supports continued funding or expansion
New indication aligned to evidence standards If PHARMAC funds by value and economics Can create a second demand wave
Risk management improvements Strengthened safety and monitoring Improves credibility in funding review
Supply and continuity commitments Meets procurement reliability expectations Helps avoid delisting or tender displacement

What are the biggest regulatory challenges across both branded and generic entrants?

1) Funding access is the binding constraint

Even with marketing approval, commercial access depends on PHARMAC subsidy decisions. The competitive battleground is usually not Medsafe authorization but pricing and access strategy relative to PHARMAC processes.

2) Evidence expectations can still be material for “simple” updates

  • Quality changes, manufacturing variations, and updated safety evidence can require additional documentation and variation approvals.
  • This increases operational complexity for both brands and generics, especially for lifecycle changes.

3) Supply chain reliability affects access

For medicines where treatment continuity is clinically important, procurement or listing decisions can reflect supply assurance.

4) Switching dynamics reduce pricing power

Where interchangeability exists, branded differentiation must translate into measurable benefits that justify price or restricted use, otherwise dispensing patterns will shift to lower-cost alternatives.

Where are the biggest “regulatory adjacency” opportunities?

Convergence of approvals with access strategy

Smart entrants in New Zealand treat Medsafe approval and PHARMAC access planning as one workstream. The regulatory opportunity is to prepare for:

  • consistent dossier structure supporting both submission and subsequent funding discussions
  • product readiness for tender windows and expected interchangeability classification
  • pharmacovigilance system readiness from day one

What should investors and R&D planners prioritize in New Zealand?

Decision checklist for market entry

Workstream Priority Deliverable
Regulatory package readiness High Robust quality and equivalence evidence (generic) or differentiation evidence (brand)
Access strategy Highest PHARMAC-aligned pricing and tender readiness
Interchangeability implications High Dispensing impact model and substitution planning
Lifecycle plan Medium to high Evidence generation timed to funding review cycles
Supply continuity planning High Procurement-ready manufacturing and logistics assurance
Pharmacovigilance build High Operational reporting system and risk mitigation readiness

What does “success” look like under New Zealand’s subsidy-driven market?

Success is not only approval. It is sustained funded access under competitive pricing pressure.

Operational success metrics

  • Listing outcome: funded status, restrictions, and product category placement
  • Economic outcome: negotiated price or tender rank vs comparators
  • Utilisation outcome: volume retention vs switching after interchangeability/tender events
  • Lifecycle outcome: ability to expand funded use via evidence updates

Key Takeaways

  • New Zealand’s branded vs generic dynamics are dominated by PHARMAC subsidy access, with Medsafe approval as a necessary but not sufficient condition for commercial success.
  • Generic opportunities concentrate in mature off-patent markets where PHARMAC can use tendering, reference pricing, and interchangeability to shift utilisation rapidly.
  • Branded challenges are structural: once lower-cost competitors enter the funded environment, branded net pricing and volume are exposed to tender cycles and switching.
  • The main regulatory challenge across both categories is synchronising product approval with funded-access strategy, including interchangeability positioning, pharmacovigilance readiness, and supply continuity.
  • Investors and R&D planners should treat New Zealand as a pricing-and-access problem first and a registration problem second.

FAQs

  1. Is Medsafe approval the main barrier for generics in New Zealand?
    It is necessary for marketing but commercial outcomes are primarily determined by PHARMAC listing, tendering, and interchangeability rules.

  2. What drives faster switching between branded and generic products?
    Pharmacy-level substitution where interchangeability applies, combined with PHARMAC’s funded pricing and procurement decisions.

  3. How can branded firms improve odds of continued funded access?
    By aligning lifecycle evidence and risk management to the clinical use and value thresholds that PHARMAC can fund under competitive economics.

  4. What types of market events usually erode branded volumes?
    Tender re-procurements, subsidy renegotiations that compress net prices, and delistings or restrictions that shift funded utilisation.

  5. Which operational capabilities most affect entry outcomes for either category?
    Dossier quality and equivalence or differentiation readiness, pharmacovigilance systems, supply continuity for procurement, and PHARMAC-aligned access execution.

References

[1] Medsafe. New Zealand Medicines and Medical Devices Safety Authority. https://www.medsafe.govt.nz/
[2] Pharmaceutical Management Agency (PHARMAC). Medicines assessment and funding framework materials. https://www.pharmac.govt.nz/
[3] New Zealand Formulary. Medicines information and funded product context. https://www.nzformulary.org/

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