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

New Zealand: These 26 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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

Preferred citation:
Friedman, Yali, "New Zealand: These 26 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
Media collateral

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 ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2025
Generic Entry Controlled by: New Zealand Patent 568,700
Patent Title: Solid stabilized particulate formulations comprising ganaxolone

ZTALMY is a drug marketed by There has been litigation on patents covering ZTALMY

See drug price trends for ZTALMY.

The generic ingredient in ZTALMY is ganaxolone. Additional details are available on the ganaxolone profile page.

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

Generic name: fluciclovine f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 29, 2025
Generic Entry Controlled by: New Zealand Patent 568,179
Patent Title: Cyclobutane derivative as a precursor compound of radioactive halogen labeled organic compound

AXUMIN is a drug marketed by

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

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

Generic name: selumetinib sulfate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2025
Generic Entry Controlled by: New Zealand Patent 569,792
Patent Title: Novel hydrogen sulphate benzimidazole salt

KOSELUGO is a drug marketed by There has been litigation on patents covering KOSELUGO

See drug price trends for KOSELUGO.

The generic ingredient in KOSELUGO is selumetinib sulfate. Additional details are available on the selumetinib sulfate profile page.

When can LEXISCAN (regadenoson) generic drug versions launch?

Generic name: regadenoson
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 03, 2026
Generic Entry Controlled by: 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 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. Additional details are available on the regadenoson profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: New Zealand Patent 570,538
Patent Title: Intravenous antiviral treatments

RAPIVAB is a drug marketed by

See drug price trends for RAPIVAB.

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

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

Generic name: florbetapir f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: New Zealand Patent 570,887
Patent Title: Styrylpyridine derivatives and their use for binding and imaging amyloid plaques

AMYVID is a drug marketed by There has been litigation on patents covering AMYVID

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

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: New Zealand Patent 571,690
Patent Title: Ocular allergy treatments using alcaftadine

LASTACAFT is a drug marketed by There has been litigation on patents covering LASTACAFT

See drug price trends for LASTACAFT.

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

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: New Zealand Patent 595,983

TRADJENTA is a drug marketed by Six tentatively approved generics are ready to enter the market. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

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

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

Generic name: vortioxetine hydrobromide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
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

TRINTELLIX is a drug marketed by Two tentatively approved generics are ready to enter the market. 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. Additional details are available on the vortioxetine hydrobromide 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

XADAGO is a drug marketed by 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. Additional details are available on the safinamide mesylate 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

BYDUREON is a drug marketed by 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. 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 589,195

FARXIGA is a drug marketed by Sixteen tentatively approved generics are ready to enter the market. 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. 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 589,195

QTERN is a drug marketed by 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. Additional details are available on the dapagliflozin; saxagliptin hydrochloride 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

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

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

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

BRILINTA is a drug marketed by 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. There are twenty-one drug master file entries for this API. 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

OPSUMIT is a drug marketed by One tentatively approved generic is ready to enter the market. 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. Additional details are available on the macitentan profile page.

When can OPSYNVI (macitentan; tadalafil) generic drug versions launch?

Generic name: macitentan; tadalafil
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: New Zealand Patent 575,702

OPSYNVI is a drug marketed by There has been litigation on patents covering OPSYNVI

See drug price trends for OPSYNVI.

The generic ingredient in OPSYNVI is macitentan; tadalafil. There are ten drug master file entries for this API. Additional details are available on the macitentan; tadalafil 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 One tentatively approved generic is ready to enter the market. 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. 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

When can LYNPARZA (olaparib) generic drug versions launch?

Generic name: olaparib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 17, 2026
Generic Entry Controlled by: New Zealand Patent 575,627

LYNPARZA is a drug marketed by Two tentatively approved generics are ready to enter the market. There has been litigation on patents covering LYNPARZA

See drug price trends for LYNPARZA.

The generic ingredient in LYNPARZA is olaparib. There are three drug master file entries for this API. Additional details are available on the olaparib 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

ENTRESTO SPRINKLE is a drug marketed by 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. 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

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 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 XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 23, 2026
Generic Entry Controlled by: New Zealand Patent 568,289

XALKORI is a drug marketed by

See drug price trends for XALKORI.

The generic ingredient in XALKORI is crizotinib. Additional details are available on the crizotinib 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
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

See drug price trends for SIRTURO.

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

PICATO is a drug marketed by 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. There are three drug master file entries for this API. Additional details are available on the ingenol mebutate profile page.

When can AMELUZ (aminolevulinic acid hydrochloride) generic drug versions launch?

Generic name: aminolevulinic acid hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 22, 2026
Generic Entry Controlled by: New Zealand Patent 577,061
Patent Title: NANOEMULSION

AMELUZ is a drug marketed by

See drug price trends for AMELUZ.

The generic ingredient in AMELUZ is aminolevulinic acid hydrochloride. There are six drug master file entries for this API. Additional details are available on the aminolevulinic acid hydrochloride profile page.

Last updated: July 27, 2025

Introduction

New Zealand represents a unique pharmaceutical landscape characterized by a relatively small population, high healthcare standards, and a tightly regulated drug approval environment. Its pharmaceutical market is distinguished by the coexistence of innovative branded drugs and cost-effective generics, underpinning government policies focused on sustainable healthcare spending and patient access. An in-depth assessment reveals specific opportunities for market growth, highlights regulatory hurdles, and indicates strategic pathways for stakeholders including pharmaceutical companies, investors, and healthcare providers.

Market Overview

Market Size and Composition

The New Zealand pharmaceutical market was valued at approximately NZD 1.4 billion ($950 million) in 2022, with growth driven by demographic shifts, increasing burden of chronic diseases, and an aging population [1]. Branded drugs account for a substantial portion of sales, primarily due to high-cost specialty medicines and innovative therapeutics, while generics represent a critical component, offering cost savings and broad access.

Market Segmentation

Branded Drugs: Focused on specialized therapies including oncology, rare diseases, and biologics.
Generics: Constituting over 70% of prescriptions by volume, driven by government initiatives promoting generic substitution.
Over-the-counter (OTC): An expanding segment reflecting consumer health priorities.

Regulatory Environment in New Zealand

Therapeutic Goods Administration (TGA) and Medsafe

New Zealand’s primary regulatory body, Medsafe, operates under the Ministry of Health, responsible for the regulation of medicines and medical devices, primarily through the Medicines Act 1981 and the Healthcare Plus Act 2007. Medsafe's procedures prioritize safety, efficacy, and quality, aligned with international standards.

Approval Pathways and Timelines

New Medicine Approval: Requires submission of comprehensive dossiers demonstrating safety, efficacy, and quality.
Generic Medicines: Must demonstrate bioequivalence and quality standards comparable to the reference branded product.
Accelerated Pathways: For orphan drugs and breakthrough therapies, allowing earlier access under specific criteria.

Pricing and Reimbursement Policies

New Zealand employs a government-led fee schedule negotiated via Pharmac, the nation’s drug purchasing agency. Pharmac’s approach emphasizes cost containment, favoring generics and biosimilars, with a focus on value-based procurement. Reimbursement rights are tied to approval and inclusion on the Pharmaceutical Schedule, influencing market access.

Opportunities in the New Zealand Market

Growing Demand for Innovative Therapies

Despite the small population, New Zealand offers strategic entry points for niche, high-value therapeutics, especially related to oncology, rare diseases, and biologics. Its proximity and trade agreements facilitate access to Asia-Pacific markets.

Expansion of Generic and Biosimilar Markets

Stringent cost controls present compelling opportunities for generics and biosimilars, which can significantly reduce public healthcare expenditure. The government’s emphasis on increasing biosimilar uptake post-patent expiries offers a fertile environment for growth.

Digital and Remote Healthcare Integration

The COVID-19 pandemic accelerated telehealth adoption, opening channels for pharmaceutical companies to deploy digital health solutions, patient support programs, and remote monitoring devices.

Private Sector Collaborations

Partnerships with local healthcare providers and research institutions can accelerate clinical development, facilitate market entry, and support pharmacovigilance efforts.

Challenges Facing Stakeholders

Regulatory Complexity and Stringency

While Medsafe maintains high safety standards, the approval process can be lengthy and resource-intensive, especially for innovative biologics and targeted therapies, which face rigorous scrutiny and data requirements.

Market Size Limitations

The small population (~5 million) constrains revenue potential, necessitating a focus on high-margin or niche therapeutics. Companies must also navigate the risk of limited commercial returns.

Price Pressures and Cost Containment

Pharmac’s emphasis on cost-effective procurement hampers pricing flexibility, favoring generics and biosimilars over brand-name products. The emphasis on affordability may challenge premium pricing strategies.

Intellectual Property and Patent Challenges

Patents are rigorously examined, with provisions for compulsory licensing in cases of public health concern, potentially impacting exclusivity periods and revenue forecasts.

Regulatory Harmonization and Market Access

While alignments exist with international standards, New Zealand's specific requirements necessitate tailored submissions, adding complexity and potential delays to market entry.

Regulatory Opportunities

Enhanced Pathways for Innovative Drugs

MedSafe offers early engagement pathways, such as Scientific Advice and provisional approvals, which can streamline access for breakthrough therapies.

Biosimilar Policy Development

Government initiatives encouraging biosimilar uptake create a regulatory landscape conducive to fostering competition, with specific guidelines emerging for interchangeability and substitution.

International Collaboration and Mutual Recognition

Participation in regional harmonization efforts, such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and ICH guidelines, enhances regulatory efficiency and facilitates faster approvals for imported drugs.

Digital Regulatory Frameworks

Development of electronic submission portals and real-time surveillance systems enhances pharmacovigilance and accelerates approval timelines.

Strategic Recommendations

Prioritize niche and high-value markets: Biologics, orphan drugs, and precision medicines align with New Zealand’s demographic profile and healthcare needs.
Leverage regulatory partnerships: Engage early with Medsafe to navigate approval pathways, especially for innovative therapies.
Focus on cost-effective solutions: Develop and promote biosimilars and generics that meet quality standards to gain favor under Pharmac’s procurement strategies.
Invest in local clinical trials: Partner with academic institutions to generate local data supporting regulatory submissions and foster market acceptance.
Adopt digital health strategies: Utilize telehealth and remote monitoring tools to enhance patient engagement and adherence.

Key Takeaways

Market Dynamics: While small, New Zealand’s pharmaceutical market offers strategic niches, particularly in biologics and orphan drugs, driven by healthcare standards and demographic needs.
Regulatory Environment: Stringent but predictable, with evolving pathways favoring early access for breakthrough therapies and biosimilars.
Opportunities: Innovations in digital health, biosimilars, and targeted therapies present growth avenues, especially when aligned with government policies.
Challenges: Market size limitations, pricing pressures, and regulatory complexity require careful strategic planning.
Strategic Approach: Emphasize early regulatory engagement, focus on high-margin niche therapies, and leverage digital and local partnerships.

FAQs

1. What are the key regulatory approvals required to introduce a new drug in New Zealand?
Approval requires submission of comprehensive data demonstrating safety, efficacy, and quality to Medsafe. For generics, demonstrating bioequivalence and manufacturing quality suffices, whereas innovative medicines may undergo accelerated pathways with additional data requirements.

2. How does Pharmac’s pricing policy influence market access for new drugs?
Pharmac’s emphasis on cost-effectiveness often results in negotiated lower prices and preference for generics/biosimilars, potentially limiting premium pricing for innovative therapies but encouraging uptake of cost-efficient alternatives.

3. What opportunities exist for biologics and biosimilars in New Zealand?
Government initiatives promoting biosimilar substitution, combined with patent expiries of biological therapies, create significant opportunities. Regulatory pathways for biosimilars are aligned with international standards, facilitating their market entry.

4. Are there regional or international collaborations that can facilitate drug approval in New Zealand?
Yes. New Zealand participates in regional initiatives such as PIC/S and adheres to ICH guidelines, enabling mutual recognition and streamlining approvals for conforming products.

5. How can companies navigate the small market size to maximize profitability?
Focusing on high-margin, niche therapeutic areas such as rare diseases or biologics, combined with strategic clinical trial partnerships and digital health solutions, can optimize market penetration and profitability.

References

[1] New Zealand Ministry of Health. "Health and Disability System Review." 2022.