Last Updated: October 1, 2026

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

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New Zealand: These 37 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "New Zealand: These 37 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.
When can TYMLOS (abaloparatide) generic drug versions launch in New Zealand?

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. There has been litigation on patents covering TYMLOS

See drug price trends for TYMLOS.

The generic ingredient in TYMLOS is abaloparatide. Additional details are available on the abaloparatide profile page.

When can COTELLIC (cobimetinib fumarate) generic drug versions launch in New Zealand?

Generic name: cobimetinib fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 05, 2026
Generic Entry Controlled by: New Zealand Patent 567,140
Patent Title: Azetidines as MEK inhibitors for the treatment of proliferative diseases

COTELLIC is a drug marketed by Genentech Inc. There are seven patents protecting this drug.

See drug price trends for COTELLIC.

The generic ingredient in COTELLIC is cobimetinib fumarate. Additional details are available on the cobimetinib fumarate profile page.

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

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. There has been litigation on patents covering INREBIC

See drug price trends for INREBIC.

The generic ingredient in INREBIC is fedratinib hydrochloride. Additional details are available on the fedratinib hydrochloride profile page.

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

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. 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 in New Zealand?

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. 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 in New Zealand?

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. 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. Additional details are available on the sacubitril; valsartan profile page.

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

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. 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. Additional details are available on the sacubitril; valsartan profile page.

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

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. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. Additional details are available on the difelikefalin acetate profile page.

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

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. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. Additional details are available on the difelikefalin acetate profile page.

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

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: New Zealand Patent 576,485
Patent Title: FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL

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

See drug price trends for SIRTURO.

The generic ingredient in SIRTURO is bedaquiline fumarate. Additional details are available on the bedaquiline fumarate profile page.

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

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.

See drug price trends for ZYKADIA.

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

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

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.

See drug price trends for ZYKADIA.

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

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

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.

See drug price trends for XERMELO.

The generic ingredient in XERMELO is telotristat etiprate. Additional details are available on the telotristat etiprate profile page.

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

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. There has been litigation on patents covering PICATO

See drug price trends for PICATO.

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

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

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

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

See drug price trends for OSENI.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.

When can LEXISCAN (regadenoson) generic drug versions launch in New Zealand?

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. There has been litigation on patents covering LEXISCAN

See drug price trends for LEXISCAN.

The generic ingredient in LEXISCAN is regadenoson. Additional details are available on the regadenoson profile page.

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

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

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

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

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

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

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

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

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP is pancrelipase (amylase;lipase;protease). Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

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

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

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP is pancrelipase (amylase;lipase;protease). Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

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

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: New Zealand Patent 579,011
Patent Title: PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES

XENLETA is a drug marketed by Hong Kong. There are four patents protecting this drug. There has been litigation on patents covering XENLETA

See drug price trends for XENLETA.

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

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

Generic name: axitinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 05, 2027
Generic Entry Controlled by: New Zealand Patent 580,126

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

See drug price trends for INLYTA.

The generic ingredient in INLYTA is axitinib. Additional details are available on the axitinib profile page.

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

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. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

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

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. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

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

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. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

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

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: New Zealand Patent 580,888

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

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. Additional details are available on the eltrombopag olamine profile page.

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

Generic name: cariprazine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 11, 2027
Generic Entry Controlled by: New Zealand Patent 580,642

Drug Price Trends for VRAYLAR
VRAYLAR is a drug marketed by Abbvie. There are five patents protecting this drug. There has been litigation on patents covering VRAYLAR

See drug price trends for VRAYLAR.

The generic ingredient in VRAYLAR is cariprazine hydrochloride. Additional details are available on the cariprazine hydrochloride profile page.

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

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.

See drug price trends for SIGNIFOR LAR.

The generic ingredient in SIGNIFOR LAR is pasireotide pamoate. Additional details are available on the pasireotide pamoate profile page.

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

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: New Zealand Patent 582,423

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

See drug price trends for TRELSTAR.

The generic ingredient in TRELSTAR is triptorelin pamoate. Additional details are available on the triptorelin pamoate profile page.

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

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: New Zealand Patent 582,423

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

The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. Additional details are available on the triptorelin pamoate profile page.

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

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: New Zealand Patent 581,803

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

See drug price trends for JAKAFI.

The generic ingredient in JAKAFI is ruxolitinib phosphate. Additional details are available on the ruxolitinib phosphate profile page.

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

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. There has been litigation on patents covering KYBELLA

The generic ingredient in KYBELLA is deoxycholic acid. Additional details are available on the deoxycholic acid profile page.

When can CARDAMYST (etripamil) generic drug versions launch in New Zealand?

Generic name: etripamil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 20, 2027
Generic Entry Controlled by: New Zealand Patent 582,033
Patent Title: SHORT ACTING PHENYLALKYLAMINE CALCIUM CHANNEL BLOCKERS AND USES THEREOF

Drug Price Trends for CARDAMYST
CARDAMYST is a drug marketed by Milestone Pharms Usa. There are six patents protecting this drug. There has been litigation on patents covering CARDAMYST

See drug price trends for CARDAMYST.

The generic ingredient in CARDAMYST is etripamil. Additional details are available on the etripamil profile page.

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

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.

See drug price trends for TWIRLA.

The generic ingredient in TWIRLA is ethinyl estradiol; levonorgestrel. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

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

Generic name: tepotinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: New Zealand Patent 583,186
Patent Title: PYRIMIDINYL-PYRIDAZINONE DERIVATIVES

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

The generic ingredient in TEPMETKO is tepotinib hydrochloride. Additional details are available on the tepotinib hydrochloride profile page.

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

Generic name: tepotinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: New Zealand Patent 583,187
Patent Title: PYRIDAZINONE DERIVATIVES

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

The generic ingredient in TEPMETKO is tepotinib hydrochloride. Additional details are available on the tepotinib hydrochloride profile page.

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

Generic name: alogliptin benzoate; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 19, 2027
Generic Entry Controlled by: New Zealand Patent 583,346
Patent Title: SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

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

See drug price trends for KAZANO.

The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. Additional details are available on the alogliptin benzoate; metformin hydrochloride profile page.

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

Generic name: clascoterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: New Zealand Patent 599,437
Patent Title: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives.

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

See drug price trends for WINLEVI.

The generic ingredient in WINLEVI is clascoterone. Additional details are available on the clascoterone profile page.

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

Generic name: clascoterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: New Zealand Patent 600,767
Patent Title: ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES

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

See drug price trends for WINLEVI.

The generic ingredient in WINLEVI is clascoterone. Additional details are available on the clascoterone profile page.

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

Generic name: clascoterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: New Zealand Patent 615,953
Patent Title: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives

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

See drug price trends for WINLEVI.

The generic ingredient in WINLEVI is clascoterone. Additional details are available on the clascoterone profile page.

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

Generic name: prasterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2027
Generic Entry Controlled by: New Zealand Patent 583,147
Patent Title: DEHYDROEPIANDROSTERONE COMPOSITIONS FOR TREATING MENOPAUSE

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

See drug price trends for INTRAROSA.

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

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

Generic name: prasterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2027
Generic Entry Controlled by: New Zealand Patent 598,270
Patent Title: DHEA COMPOSITIONS FOR TREATING MENOPAUSE

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

See drug price trends for INTRAROSA.

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

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

Generic name: gallium ga-68 gozetotide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 17, 2027
Generic Entry Controlled by: New Zealand Patent 583,931

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

See drug price trends for LOCAMETZ.

The generic ingredient in LOCAMETZ is gallium ga-68 gozetotide. Additional details are available on the gallium ga-68 gozetotide profile page.

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

Generic name: gallium ga-68 gozetotide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 17, 2027
Generic Entry Controlled by: New Zealand Patent 600,085

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

See drug price trends for LOCAMETZ.

The generic ingredient in LOCAMETZ is gallium ga-68 gozetotide. Additional details are available on the gallium ga-68 gozetotide profile page.

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

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

See drug price trends for BRILINTA.

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

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

Generic name: flutemetamol f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 30, 2027
Generic Entry Controlled by: New Zealand Patent 583,616

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

See drug price trends for VIZAMYL.

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

When can PREPOPIK (citric acid; magnesium oxide; sodium picosulfate) generic drug versions launch in New Zealand?

Generic name: citric acid; magnesium oxide; sodium picosulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 12, 2027
Generic Entry Controlled by: New Zealand Patent 583,899
Patent Title: PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE

PREPOPIK is a drug marketed by Ferring Pharms Inc. There are two patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market. There has been litigation on patents covering PREPOPIK

See drug price trends for PREPOPIK.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

When can VELPHORO (sucroferric oxyhydroxide) generic drug versions launch in New Zealand?

Generic name: sucroferric oxyhydroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 16, 2027
Generic Entry Controlled by: New Zealand Patent 585,435
Patent Title: PHARMACEUTICAL COMPOSITIONS COMPRISING IRON OXY-HYDROXIDE

Drug Price Trends for VELPHORO
VELPHORO is a drug marketed by Vifor Fresenius. There are eleven patents protecting this drug. There has been litigation on patents covering VELPHORO

See drug price trends for VELPHORO.

The generic ingredient in VELPHORO is sucroferric oxyhydroxide. Additional details are available on the sucroferric oxyhydroxide profile page.

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

Generic name: allopurinol; lesinurad
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 27, 2027
Generic Entry Controlled by: New Zealand Patent 601,786
Patent Title: Novel compounds and compositions and methods of use

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

See drug price trends for DUZALLO.

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

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

Generic name: lesinurad
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 27, 2027
Generic Entry Controlled by: New Zealand Patent 601,786
Patent Title: Novel compounds and compositions and methods of use

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

See drug price trends for ZURAMPIC.

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

New Zealand Branded vs Generic Drug Markets Assessment: Regulatory Opportunities, Barriers, Pricing, and Patent Risk

Last updated: May 12, 2026

New Zealand’s branded and generic medicines market is small but structurally “high-friction” for entrants: New Zealand’s medicines access system is tightly controlled by the Pharmaceutical Management Agency (PHARMAC), with pricing and reimbursement decisions driven by cost-effectiveness and managed access rather than free market competition. Regulatory opportunities exist in line-extension submissions, biosimilar switching pathways, and targeted product lifecycle strategies that align with PHARMAC contracting dynamics. Core challenges cluster around formulary entry barriers, substitution rules, parallel import risk controls, tendering leverage, and IP-driven delays that can limit launch timing.


How big are New Zealand branded and generic drug markets by value and volume?

Featured snippet answer: New Zealand’s medicines spend is centralized through PHARMAC-managed medicines listings; generic utilization is high in many therapeutic areas, but overall market value is dominated by the PHARMAC-funded branded segment, with generic growth shaped by tender cycles and formulary placement rather than uptake alone.

Market structure that drives “branded vs generic” outcomes

New Zealand differs from larger markets because the government payer is the dominant demand shaper. Practical implications:

  • Branded medicines win primarily through PHARMAC listing and contracted pricing; volumes often depend on therapeutic area budget constraints and negotiation.
  • Generic medicines win primarily through tender outcomes, listing inclusion, and price-volume tradeoffs. Launch timing is not enough without payer adoption.

Where generic competition actually bites

Generic competitive pressure tends to be strongest when:

  • A brand product is already widely used and therapeutic switching can occur without clinical disruption.
  • Multiple generics can supply reliably at contracted prices.
  • PHARMAC has an explicit contracting preference or tender that reduces differential between suppliers.

What is the New Zealand regulatory pathway for generic and branded medicines?

Featured snippet answer: Generic medicines in New Zealand follow an approval pathway under the medicines regulatory framework administered through Medsafe, with requirements for quality, bioequivalence (for systemically acting drugs), and labeling consistent with the reference product.

Who regulates medicines in New Zealand?

  • Medsafe regulates medicines under the Medicines Act framework and associated regulations (including product evaluation and approvals).
  • PHARMAC decides which medicines are funded on the New Zealand Pharmaceutical Schedule.

Typical regulatory gates for entrants

  • Quality and manufacturing compliance (GMP).
  • Bioequivalence studies for most generics and certain line extensions.
  • Clinical data expectations depend on whether the product is a true generic, hybrid, or reformulation.
  • Labeling and safety updates must align with the reference product.

What is the Orange Book equivalent in New Zealand, and how does it affect generic entry?

Featured snippet answer: New Zealand does not use the US FDA Orange Book “listed patents” framework. Instead, patent and regulatory timing are governed through New Zealand patent law and the interaction between market access contracting (PHARMAC) and regulatory approvals (Medsafe), with litigation and patent infringement risk shaping launch readiness.

Practical IP interaction without Orange Book listings

Without a patent-listing mechanism that automatically flags exclusivity windows to generic applicants, the primary levers are:

  • Patent status and enforceability in New Zealand.
  • Infringement analysis against each claimed generic product and process.
  • Regulatory timing that enables a product to be manufactured, submitted, and approved even while market entry remains constrained by IP risk and payer contracting.

Risk point for generic companies

Even if Medsafe approval is obtainable, the commercial launch can still be blocked by:

  • Patent infringement exposure.
  • Contracting leverage: PHARMAC can delay or sequence listing decisions across suppliers.

How does PHARMAC pricing and contracting shape branded vs generic outcomes?

Featured snippet answer: PHARMAC uses cost-effectiveness assessment and purchasing leverage to negotiate access. Branded entry is often constrained by budget impact and comparator selection. Generic entry is driven by tendering and contracted pricing, not only regulatory approval.

PHARMAC decision mechanics that determine market share

  • Listing decisions are driven by clinical benefit plus cost-effectiveness.
  • Contracting can create periods where one supplier has commercial advantage even after generics are approved.
  • Managed access frameworks can limit switching speed.

What this means for launch strategy

  • For branded products, the “regulatory win” is not the “market access win.” Contract terms, restrictions, and stepwise adoption can limit early volume.
  • For generics, the key is winning the reimbursement slot and meeting supply requirements at PHARMAC-contracted terms.

When does New Zealand generic substitution happen, and what are the switching constraints?

Featured snippet answer: Substitution and switching are constrained by policy and clinical governance. Where substitution is permitted, payer and prescriber behavior can still influence real-world uptake; where it is restricted, brand retention can persist even after generic availability.

Substitution constraints that matter commercially

  • Formulation equivalence: if the generic differs in formulation attributes that affect administration or clinical profile, uptake slows.
  • Patient and prescriber acceptance: switching can be slower in high-risk therapeutic categories.
  • Dispensing pharmacy practices can influence substitution speed.

Litigation and safety monitoring can slow switching

Even with a generic available, safety communications, regulator updates, or contested patient-facing labeling can delay adoption.


What patent landscape governs drug launches in New Zealand?

Featured snippet answer: Patent protection in New Zealand covers both active ingredient inventions and life-cycle improvements. Generic entry risk is driven by whether relevant patents are in force in New Zealand and whether a generic would fall within claim scope for product, method, or use claims.

Typical patent estate components that affect generic competition

  • Composition of matter for active ingredients.
  • Salt polymorph, crystalline form, and hydrate claims.
  • Formulation patents (excipients, coatings, controlled release).
  • Method-of-manufacture patents.
  • Method-of-use or treatment claim patents.
  • Device and combination regimen patents (where applicable).

Litigation posture that shapes timing

Even without Orange Book-style listing, disputes can still:

  • Trigger settlement agreements controlling launch timing.
  • Force design-around or product labeling changes.
  • Delay inclusion in payer contracts through commercial settlement leverage.

What generic entry risks exist for top therapeutic classes in New Zealand?

Featured snippet answer: Generic entry risk is highest where patents cover not just the active ingredient but also formulation, dosing regimen, and method-of-use. Risk is lower where estates are narrow and early-life cycles are limited.

Higher-risk categories

  • Specialty oncology and immunology with combination regimens.
  • Controlled-release or complex delivery systems with formulation-heavy estates.
  • Complex biologics and biosimilars where manufacturing and analytical similarity are central.

Lower-risk categories

  • Simple immediate-release small molecules with aging estates and limited life-cycle claims.
  • Where PHARMAC tenders already create competitive replacement pressure.

How do biosimilars compete in New Zealand compared with small-molecule generics?

Featured snippet answer: Biosimilar entry depends on Medsafe approval plus PHARMAC listing and uptake. Competitive dynamics are more complex than small-molecule generics because interchangeability, immunogenicity monitoring, and clinician confidence affect switching speed.

Key barriers for biosimilars

  • Tender selection and contracting terms.
  • Risk management and pharmacovigilance expectations.
  • Traceability and manufacturing consistency requirements.

Commercial opportunity

  • Switching from originators where PHARMAC’s cost-containment objectives favor lower-cost alternatives.
  • Portfolio expansion with additional indications where it aligns with payer decisions.

What settlements and patent litigation patterns matter in New Zealand?

Featured snippet answer: Patent settlements can influence launch timing and supply availability even when regulatory approval is possible. The market access effect can be as important as the infringement outcome.

Common practical settlement pathways

  • Design-around to avoid claim scope.
  • Calendar-based settlement controlling “first market supply” timing.
  • Licensing arrangements that permit market entry under defined constraints.

Why New Zealand-specific timing still matters

Even if litigation is slower than the US in some cases, PHARMAC contracting windows can create real commercial deadlines. Settlement often aligns with tender cycles.


What are the main regulatory and compliance opportunities for manufacturers in New Zealand?

Featured snippet answer: Opportunities concentrate on manufacturing quality systems, fast turnaround bioequivalence/comparability packages, supply reliability for tendered contracts, and lifecycle products that meet Medsafe standards and fit PHARMAC access strategies.

Actionable opportunity themes

  • Tender-ready supply chains with validated batch-to-batch consistency.
  • Regulatory dossiers tuned to expected equivalence and labeling alignment.
  • Line extensions that can qualify for listing if clinical differentiation is accepted by the payer.
  • Portfolio rationalization to reduce SKUs while maintaining access for each therapeutic need.

What regulatory challenges can delay or block launches in New Zealand?

Featured snippet answer: The most common launch delays are dossier gaps, bioequivalence evidence weaknesses, manufacturing quality deviations, and labeling inconsistencies. Commercially, the biggest delays stem from PHARMAC listing timelines and tender sequencing rather than Medsafe approval alone.

Medsafe-facing challenge set

  • Incomplete comparative documentation and inadequate bioequivalence methodology.
  • GMP deviations or insufficient validation.
  • Labeling and risk management plan misalignment with the reference medicine.

PHARMAC-facing challenge set

  • Budget impact concerns.
  • Comparator selection that raises cost-effectiveness hurdles.
  • Tender outcomes that relegate some entrants to non-listed status.

Which companies typically lead branded and generic access in New Zealand?

Featured snippet answer: Leadership is concentrated among firms that can win PHARMAC contracting and maintain supply. Branded access is dominated by originator companies with strong market access teams. Generics leadership tends to belong to established generic manufacturers that can execute tenders and sustain contracted pricing.

Commercial patterns to expect

  • Brand owners: negotiate lifecycle differentiation, new indications, and sometimes restricted access based on evidence.
  • Generic entrants: compete on lowest total cost consistent with reliable supply and regulatory readiness.

How should companies model New Zealand revenue exposure versus US/EU?

Featured snippet answer: New Zealand revenue exposure is typically modest in absolute dollars but can be strategically significant as a reference market for global launches, as well as a foothold for payer evidence packages and post-approval pharmacovigilance.

Revenue model inputs that matter most

  • Probability of PHARMAC listing for the target indication.
  • Expected uptake under substitution/switching rules.
  • Contract price and tender renewal cadence.
  • Patent risk delay window impacting “first funded patient” timing.

What commercial launch scenarios are plausible for generics in New Zealand?

Featured snippet answer: A generic can be approved yet commercially delayed if PHARMAC does not list it or if patent risk blocks contracting. The winning scenario is approval plus timely listing during a tender window after any relevant patent or settlement constraints lapse.

Scenario map

  • Scenario A (fast path): No blocking patents in force in New Zealand; PHARMAC tender supports rapid listing; generic enters funded category quickly.
  • Scenario B (moderate delay): Approval occurs, but listing is sequenced to a later tender or contract renewal; revenue starts later than approval.
  • Scenario C (blocked launch): Patent infringement risk triggers litigation or settlement restrictions; generic is not funded or is delayed until resolution.

How strong is the overall patent estate for common New Zealand originators?

Featured snippet answer: Patent estate strength is highest where originators file extensive lifecycle patents covering formulations, dosing regimens, and manufacturing processes. Estate strength is lower when originators allow earlier patents to lapse without meaningful life-cycle continuation.

What to measure in due diligence

  • Count of in-force patents in New Zealand for each product and dose form.
  • Remaining term by patent type: composition vs formulation vs method-of-use.
  • Claim scope breadth and how likely generic design-around is.

Key Takeaways

  • New Zealand branded vs generic competition is driven by PHARMAC listing and contracting, not by regulatory approval alone.
  • IP risk is still central, even without an Orange Book patent listing framework; enforceable patents and settlement dynamics can delay market access.
  • Generic and biosimilar opportunities exist but depend on tender alignment, supply reliability, and lifecycle strategy that fits payer cost-effectiveness decisions.
  • Practical barriers cluster around dossier readiness (Medsafe) and market access timing (PHARMAC), with litigation and settlements shaping launch calendars.

FAQs

1) What does New Zealand require for a generic to demonstrate bioequivalence?
Bioequivalence evidence and product quality must meet Medsafe requirements appropriate to the formulation and route, typically demonstrating comparable pharmacokinetic exposure versus the reference product.

2) How do PHARMAC tenders influence generic market entry timing?
Tender outcomes determine which supplier is contracted for reimbursement, so funded entry can lag regulatory approval until the next contracting cycle or inclusion in the schedule.

3) Can a generic be approved by Medsafe before a relevant New Zealand patent expires?
Approval and market entry are distinct; regulatory approval does not eliminate infringement risk, and contracting can still be constrained by patent status.

4) How do biosimilar switching policies differ from small-molecule generic substitution?
Biosimilar uptake typically depends on clinician and payer confidence, pharmacovigilance monitoring expectations, and tender selection, creating slower switching dynamics than many small-molecule categories.

5) What are the most common reasons generic applicants struggle with market access in New Zealand?
Dossier deficiencies, manufacturing compliance issues, and, most often, failure to secure favorable PHARMAC listing terms during tendering or cost-effectiveness assessment.


References

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