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

World Intellectual Property Organization (WIPO): These 27 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "World Intellectual Property Organization (WIPO): These 27 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.

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

Generic name: leuprolide mesylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: January 18, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,084,460

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

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

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

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,095,218

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

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

See drug price trends for RAPIVAB.

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

When can VOCABRIA (cabotegravir sodium) generic drug versions launch?

Generic name: cabotegravir sodium
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,006,088,173

VOCABRIA is a drug marketed by Viiv Hlthcare. There are two patents protecting this drug.

This drug has one hundred and twenty-six patent family members in thirty-three countries.

The generic ingredient in VOCABRIA is cabotegravir sodium. One supplier is listed for this generic product. Additional details are available on the cabotegravir sodium 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: World Intellectual Property Organization (WIPO) Patent 2,007,126,733

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

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

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

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,117,971

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

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

See drug price trends for LASTACAFT.

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

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: April 12, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,117,241

When can ORENITRAM (treprostinil diolamine) generic drug versions launch?

Generic name: treprostinil diolamine
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: April 27, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,127,216

ORENITRAM is a drug marketed by United Therap. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-nine patent family members in eight countries. There has been litigation on patents covering ORENITRAM

See drug price trends for ORENITRAM.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are nineteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the treprostinil diolamine 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: World Intellectual Property Organization (WIPO) Patent 2,007,128,724

TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

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

See drug price trends for TRADJENTA.

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

When can VICTRELIS (boceprevir) generic drug versions launch?

Generic name: boceprevir
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: May 31, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,006,130,628

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

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

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

When can 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: World Intellectual Property Organization (WIPO) Patent 2,007,144,005

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

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

See drug price trends for TRINTELLIX.

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

When can VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,008,002,576

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

The generic ingredient in VAFSEO is vadadustat. One supplier is listed for this generic product. Additional details are available on the vadadustat 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: World Intellectual Property Organization (WIPO) Patent 2,008,002,824

BYDUREON is a drug marketed by Astrazeneca Ab. There are eleven patents protecting this drug.

This drug has three hundred and forty-six 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: World Intellectual Property Organization (WIPO) Patent 2,008,002,824

FARXIGA is a drug marketed by Astrazeneca Ab. There are nineteen patents protecting this drug and one Paragraph IV challenge. Sixteen tentatively approved generics are ready to enter the market.

This drug has four hundred and fifty 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. Five 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: World Intellectual Property Organization (WIPO) Patent 2,008,002,824

QTERN is a drug marketed by Astrazeneca Ab. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and thirteen 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 RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,008,009,476

RASUVO is a drug marketed by Medexus. There is one patent protecting this drug.

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

See drug price trends for RASUVO.

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

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

Generic name: simeprevir sodium
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 28, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,014,926

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

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

See drug price trends for OLYSIO.

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

When can 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: World Intellectual Property Organization (WIPO) Patent 2,008,016,077

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. One supplier is listed for this generic product. 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: World Intellectual Property Organization (WIPO) Patent 2,007,020,259

CREON is a drug marketed by

This drug has twenty patent family members in sixteen 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. One supplier is listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

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

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: World Intellectual Property Organization (WIPO) Patent 2,007,038,315

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

This drug has two hundred and sixty-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 ZUNVEYL (benzgalantamine gluconate) generic drug versions launch?

Generic name: benzgalantamine gluconate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,039,138

ZUNVEYL is a drug marketed by Alpha Cognition. There are three patents protecting this drug.

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

The generic ingredient in ZUNVEYL is benzgalantamine gluconate. One supplier is listed for this generic product. Additional details are available on the benzgalantamine gluconate 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: World Intellectual Property Organization (WIPO) Patent 2,008,057,608

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 XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 23, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,066,185

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

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

See drug price trends for XALKORI.

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

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,062,266

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

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

See drug price trends for ZTALMY.

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

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

Generic name: buprenorphine hydrochloride; naloxone hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,008,068,471

ZUBSOLV is a drug marketed by Orexo Us Inc. There are ten patents protecting this drug and four Paragraph IV challenges. Two tentatively approved generics are ready to enter the market.

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

See drug price trends for ZUBSOLV.

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

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

Generic name: selumetinib sulfate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,076,245

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

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

See drug price trends for KOSELUGO.

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

When can 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: World Intellectual Property Organization (WIPO) Patent 2,007,068,963

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 VYKAT XR (diazoxide choline) generic drug versions launch?

Generic name: diazoxide choline
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 20, 2026
Generic Entry Controlled by: World Intellectual Property Organization (WIPO) Patent 2,007,081,521

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

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

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

Last updated: July 27, 2025

Introduction

The pharmaceutical industry operates within a complex framework shaped by intellectual property rights, regulatory pathways, and market dynamics. As global health demands increase and technological innovations expand, understanding the interplay between WIPO’s initiatives and the branded and generic drug markets becomes critical for stakeholders. This article evaluates WIPO’s role in the globalization of drug intellectual property (IP), analyzes market opportunities, and identifies regulatory challenges facing branded and generic drug manufacturers.

WIPO’s Role in Pharmaceutical Intellectual Property

The World Intellectual Property Organization (WIPO), established in 1967, facilitates international cooperation in IP rights protection and enforcement. Its Patent Cooperation Treaty (PCT), Madrid Protocol for trademarks, and Intellectual Property Rights (IPR) infrastructure development aid in harmonizing patent systems across nations, accelerating drug development, and fostering innovation.

In the pharmaceutical sector, WIPO’s Development Agenda and Technology Transfer Initiatives promote access to affordable medicines by balancing IP incentives with public health needs. The organization plays a strategic role in shaping global IP policies, influencing patent filing practices, and fostering the transfer of technology for generic drug manufacturing, especially in low- and middle-income countries (LMICs).

Market Dynamics: Branded vs. Generic Drugs

The pharmaceutical market bifurcates into two primary sectors: branded drugs protected by patents and generics introduced post-expiry of patent protections. The dynamics between these sectors influence global drug accessibility, pricing, and innovation.

Branded Drugs: These encompass innovative molecules with patent protection, usually lasting 20 years. They offer high profit margins, incentivizing substantial R&D investments. However, patent exclusivity constrains competition, often leading to high prices.
Generic Drugs: Once patents expire, generic manufacturers enter the market, offering cost-effective alternatives. Generics significantly increase access to essential medicines, especially in resource-constrained settings, but face regulatory, legal, and manufacturing challenges.

Opportunities in the Global Market

1. Expanding Patent Protections and Market Access

WIPO’s patent filing systems streamline global patent protections, enabling pharmaceutical companies to extend market reach. The PCT system facilitates patent applications in multiple countries with coordinated procedures, reducing time and costs (WIPO, 2022). This provides the opportunity for branded drug firms to secure international IP rights and delay generic entry legally.

2. Technology Transfer and Licensing

WIPO’s Access to Genetic Resources and Associated Traditional Knowledge program and NEPAD/IP-PR Program aim to facilitate technology transfer to generic manufacturers in LMICs. Licensing agreements foster local production, improve access to generics, and open new markets.

3. Incentivizing Innovation in Emerging Markets

The strengthened IP framework encourages R&D investments tailored to unmet health needs. For companies, strategic patent filings in emerging markets open growth avenues with less intense competition, provided regulatory pathways are navigated effectively.

4. Regulatory Harmonization

WIPO collaborates with regional organizations to harmonize drug approval procedures, reducing barriers for generics and biosimilars. The International Pharmaceutical Regulators Programme (PQ/IRPP) and the ICH guidelines offer standardized data requirements, facilitating quicker approvals.

Challenges in the Market Landscape

1. Balancing IP Rights and Public Health Needs

While patents incentivize innovation, they can delay generic entry, impacting drug affordability. The World Trade Organization’s (WTO) TRIPS Agreement permits compulsory licensing under certain conditions, but legal and procedural complexities hinder timely access in LMICs.

2. Patent Evergreening and Strategic Patent Filing

Patent evergreening—obtaining secondary patents on minor modifications—prolongs exclusivity periods, complicating generic market entry. This legal strategy often conflicts with public health objectives and is a significant concern for regulators.

3. Regulatory Divergence and Delays

Despite efforts for harmonization, national regulatory frameworks vary widely. Countries with resource constraints face lengthy approval times, limiting access to generics and biosimilars. Navigating diverse regulatory landscapes remains a persistent barrier.

4. IP Enforcement and Patent Litigation

Strengthening IP rights through enforcement can lead to patent litigation, discouraging generic competition. Conversely, weaker enforcement can lead to IP infringements, impacting innovator incentives.

5. Ensuring Equitable Access

The debate around IP protections complicates access to essential medicines during health crises, as seen with COVID-19 vaccines. Balancing patent rights with international public health obligations remains an ongoing challenge for policymakers.

Regulatory Opportunities and Strategic Approaches

1. Leveraging WIPO’s Mediation and Dispute Resolution

WIPO’s arbitration and mediation services provide mechanisms for resolving patent disputes efficiently, fostering a conducive environment for both innovators and generics.

2. Embracing International Patents Data Sharing

WIPO’s Patent Landscapes and IP analytics aid stakeholders in identifying patent landscapes, enabling strategic patent filings and avoiding infringement risks—crucial for generic firms positioning themselves post-patent expiry.

3. Promoting Local Innovation Ecosystems

Supporting local R&D through Patent Cooperation Treaty (PCT)-related incentives encourages indigenous innovation, reducing reliance on foreign patents and fostering domestic generic manufacturing capabilities.

4. Facilitating Fair Licensing and Compulsory Licensing

Regulatory frameworks can incentivize fair licensing arrangements and permit compulsory licensing during health emergencies, facilitated through WTO and WIPO mechanisms, to improve access while respecting IP rights.

Future Perspectives

The future of the branded and generic drug markets depends on a nuanced approach that promotes innovation without compromising public health. Digitalization, AI-enabled patent searches, and global data-sharing through WIPO are transforming IP management, expediting drug development and access. However, regulatory harmonization and dynamic patent strategies will critically influence market evolution.

Key Takeaways

WIPO plays a vital role in shaping international pharmaceutical IP policies, facilitating patent protections, and supporting technology transfer for generics.
Market opportunities lie in strategic patent filings, licensing, and regional regulatory harmonization, enabling manufacturers to expand globally.
Challenges include balancing patent rights with public health, navigating patent evergreening, and addressing regulatory disparities.
Enhancing dispute resolution mechanisms and data-sharing can mitigate IP conflicts and streamline approval processes.
Policymakers must develop balanced frameworks to foster innovation while ensuring equitable access to essential medicines.

FAQs

1. How does WIPO influence global patent strategies for pharmaceuticals?
WIPO’s PCT system simplifies international patent filings, enabling pharma companies to secure patent rights across multiple jurisdictions efficiently, influencing global patent landscapes and exclusivity periods.

2. What are the main challenges faced by generic manufacturers in emerging markets?
Generic firms contend with complex regulatory processes, patent litigation, patent evergreening strategies, and sometimes limited capacity for technology transfer, which hinder rapid market entry.

3. How can regulatory harmonization benefit the generic drug market?
Harmonized approval standards reduce duplication of testing and streamline registration, minimizing delays and costs, thus facilitating quicker access to affordable generics.

4. What is patent evergreening, and why is it contentious?
Evergreening involves securing secondary patents on minor modifications of existing drugs, extending patent life beyond original terms and delaying generic competition, which raises public health concerns.

5. How can international cooperation improve access to medicines during health crises?
Mechanisms like compulsory licensing, facilitated through WIPO and WTO frameworks, enable countries to circumvent patents temporarily, thereby increasing access to essential medicines during emergencies.

Sources:

WIPO (2022). International Patent System Overview. [online] Available at: https://www.wipo.int/pct/en/
World Trade Organization (2022). TRIPS and Public Health. [online] Available at: https://www.wto.org/english/tratop_e/trips_e/public_health_e.htm
WHO (2021). Access to Medicines and Patent Policy. World Health Organization.
IMS Health (2020). Global Healthcare Trends.
Center for Strategic & International Studies (CSIS) (2021). Intellectual Property and Global Health.