PEMFEXY Drug Patent Profile

When do Pemfexy patents expire, and when can generic versions of Pemfexy launch?

Pemfexy is a drug marketed by Eagle Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in five countries.

The generic ingredient in PEMFEXY is pemetrexed. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pemetrexed profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pemfexy

A generic version of PEMFEXY was approved as pemetrexed by ACTAVIS on August 21^st, 2020.

Summary for PEMFEXY

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEMFEXY

US Patents and Regulatory Information for PEMFEXY

PEMFEXY is protected by five US patents.

This potential generic entry date is based on patent 9,604,990.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes	12,115,164
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes	11,793,813		Y
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020		RX	Yes	Yes	9,604,990			Y

International Patents for PEMFEXY

When does loss-of-exclusivity occur for PEMFEXY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

European Patent Office

Israel

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PEMFEXY around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1313508
Portugal	1313508
World Intellectual Property Organization (WIPO)	2016068796

Supplementary Protection Certificates for PEMFEXY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	7/2005	Austria		PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677	SPC/GB05/011	United Kingdom		PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920

Investment and Fundamentals Analysis of PEMFEXY (Pemetrexed)

Last updated: February 20, 2026

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What is PEMFEXY?

PEMFEXY (pemetrexed) is a chemotherapeutic agent indicated primarily for non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. It is marketed by Eli Lilly and Co. under the brand name PEMFEXY, approved by the FDA in October 2019.

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Market Overview

Indications and Usage

• First-line treatment for malignant pleural mesothelioma in combination with cisplatin.
• Maintenance therapy for NSCLC after platinum-based chemotherapy.

Estimated Patient Population

Disease	Global Patient Count	US Patient Count (2022)	Market Penetration (2022)
Non-small cell lung cancer (NSCLC)	2.2 million	200,000	55%
Malignant pleural mesothelioma	30,000	3,000	40%

Data sources: Globocan 2022, FDA labels, PhRMA reports.

Revenue Potential

Global NSCLC market expected to reach US$15 billion in 2025 due to rising incidence and new combination therapies. Malignant pleural mesothelioma market size estimated at US$500 million, with growth driven by increased diagnosis.

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Competitive Landscape

Key Competitors

Drug	Mechanism	Market Share (2022)	Approval Status
Pemetrexed (PEMFEXY)	Antimetabolite, folate analog	45%	Approved in US, EU, and Japan
Cisplatin	Platinum-based chemotherapy	25%	Widely used gateway drug
Nintedanib	Tyrosine kinase inhibitor	15%	Approved as add-on for NSCLC
Other agents	Various	15%	Includes immunotherapy and targeted agents

Patent Status and Expiry

• US patent expiring in 2029, with data exclusivity until 2024.
• Several biosimilar candidates are under development; biosimilar market entry expected by 2025.

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Regulatory and Patent Considerations

• Patent protection in US and Europe until 2029.
• Orphan drug designation for mesothelioma benefits exclusivity through 2024.
• Patent challenges may emerge from biosimilar producers post-2024.

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R&D and Pipeline Developments

• Focus on combination regimens integrating PEMFEXY with PD-1 inhibitors to enhance response rates.
• Novo Nordisk, Merck, and other players investigat PK/PD modifications for better efficacy.
• Clinical Trials:
  • Phase III studies combining PEMFEXY with pembrolizumab for NSCLC.
  • Ongoing trials exploring extended indication for ovarian and gastrointestinal cancers.

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Pricing and Reimbursement Environment

Region	Price (US$/dose)	Reimbursement Status	Notes
US	$3,200	Widely reimbursed	CMS coverage, private insurers
EU	€2,500	Reimbursement varies	NHS in the UK covers 70-90% of costs
Japan	¥350,000	National health insurance	High per-dose cost compared to US market

Pricing reflects the drug's novel status, with discounts and access programs in certain regions.

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Investment Considerations

• Market Growth: Rising NSCLC incidence and mesothelioma diagnosis drive long-term revenue.
• Pipeline Risks: Limited pipeline expansion outside current indications.
• Competitive Pressure: Biosimilars could erode market share after patent expiry.
• Regulatory Factors: Patent expiry in 2029; biosimilar competition anticipated by 2025.
• Pricing and Reimbursement: Dependent on healthcare policy changes and payer negotiations.

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Key Financial Metrics (Estimates)

Metric	2022	2023 (Forecast)	2024 (Forecast)
Peak US market share (%)	45%	50%	55%
US sales (US$ million)	380	450	530
Global sales (US$ million)	620	750	900

Assumptions: Growing penetration, increasing diagnosis rates, and incremental price adjustments.

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Strategic Recommendations

• Invest in companies with licensed PEMFEXY and active pipelines expanding into combination therapies.
• Monitor biosimilar market entry and patent expiry effects.
• Focus on jurisdictions with favorable reimbursement policies and high disease prevalence.
• Consider partnerships with biotech firms developing next-generation pemetrexed formulations.

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Key Takeaways

• PEMFEXY remains a key treatment for NSCLC and mesothelioma with a competitive market share.
• Patent expiry in 2029 creates near- and mid-term revenue visibility with potential biosimilar competition post-2024.
• Pipeline developments in combination regimens could enhance future sales.
• Pricing strategies and reimbursement policies significantly influence market penetration.
• Investment success depends on navigating patent rights, biosimilar entry, and evolving treatment standards.

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FAQs

Q1: What is the primary indication for PEMFEXY?
A: Non-small cell lung cancer and malignant pleural mesothelioma.

Q2: When does PEMFEXY’s patent protection expire?
A: Patent protection expires in 2029, with data exclusivity until 2024.

Q3: How significant is biosimilar competition?
A: Biosimilars are expected to enter by 2025, potentially reducing prices and market share.

Q4: What are the main drivers of revenue growth for PEMFEXY?
A: Increasing incidence of NSCLC, expanded combination therapies, and higher market penetration.

Q5: How does reimbursement impact PEMFEXY sales?
A: Favorable reimbursement policies in key markets drive broader access and higher sales volumes.

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References

1. Globocan. (2022). Cancer Incidence and Mortality Worldwide.
2. FDA. (2019). PEMFEXY (pemetrexed) drug approval and label.
3. PhRMA. (2022). US Pharmaceutical Market Report.
4. European Medicines Agency. (2022). Market authorization for PEMFEXY.
5. Eli Lilly. (2022). Financial disclosures and pipeline update.