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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	24
Patent Applications:	3,306
Drug Prices:	Drug price information for PEMFEXY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEMFEXY
What excipients (inactive ingredients) are in PEMFEXY?	PEMFEXY excipients list
DailyMed Link:	PEMFEXY at DailyMed

See drug prices for PEMFEXY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PEMFEXY

Constraining patent/regulatory exclusivity:

9,604,990

NDA:

209472

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PEMFEXY

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 2
SCRI Development Innovations, LLC	Phase 2
NRG Oncology	Phase 3

See all PEMFEXY clinical trials

Pharmacology for PEMFEXY

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

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

EU/EMA Drug Approvals for PEMFEXY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Alimta	pemetrexed	EMEA/H/C/000564Malignant pleural mesotheliomaAlimta in combination with cisplatin is indicated for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma.Non-small-cell lung cancerAlimta in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.Alimta is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Alimta is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology.	Authorised	no	no	no	2004-09-20
KRKA d.d.	Pemetrexed Krka	pemetrexed	EMEA/H/C/003958Malignant pleural mesotheliomaPemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	Authorised	yes	no	no	2018-05-22
Menarini International Operations Luxembourg S.A.	Ciambra	pemetrexed	EMEA/H/C/003788Malignant pleural mesothelioma, , Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma., , Non-small cell lung cancer, , Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology., , Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy., , Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,	Authorised	yes	no	no	2015-12-02
Fresenius Kabi Deutschland GmbH	Pemetrexed Fresenius Kabi	pemetrexed	EMEA/H/C/003895Malignant pleural mesotheliomaPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.Non-small cell lung cancerPemetrexed Fresenius Kabi in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.Pemetrexed Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Fresenius Kabi is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.	Authorised	yes	no	no	2016-07-22

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
World Intellectual Property Organization (WIPO)	0202093
Slovenia	1313508
Portugal	1313508
Japan	5469706

Supplementary Protection Certificates for PEMFEXY

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

Market Dynamics and Financial Trajectory for PEMFEXY

Last updated: July 29, 2025

Introduction

PEMFEXY (pemetrexed for injection) remains a pivotal drug within the chemotherapy landscape, primarily indicated for non-small cell lung cancer (NSCLC), mesothelioma, and other malignancies. As a commercial asset, PEMFEXY's market trajectory is shaped by a confluence of clinical efficacy, regulatory pathways, competitive dynamics, and shifting industry trends. This analysis delineates the drug's current market environment, future growth prospects, and financial outlook based on prevailing data and industry patterns.

Regulatory Status and Market Position

PEMFEXY, developed by established pharmaceutical companies such as Johnson & Johnson and later approved by the FDA, secured U.S. marketing authorization for the treatment of malignant pleural mesothelioma in combination with cisplatin, and for NSCLC after platinum-based chemotherapy. Its regulatory approval has facilitated its incorporation into standard-of-care protocols, though its market penetration remains influenced by its positioning relative to direct competitors and biosimilar options.

The drug's patent landscape, notably the expiration of exclusivity in various jurisdictions, introduces the potential for generic competition, which could significantly impact revenues. However, patent extensions or formulation patents may temporarily delay biosimilar entry, providing a window for revenue stabilization.

Market Dynamics

1. Therapeutic Indications and Clinical Demand

PEMFEXY’s primary applications include treatment for NSCLC and malignant pleural mesothelioma, both of which carry substantial incidence rates globally. The rising burden of these cancers, driven by demographic aging and environmental factors, fuels sustained demand. However, therapeutic preferences are evolving, with immunotherapies (e.g., PD-1/PD-L1 inhibitors) gaining prominence, posing competitive challenges and potentially commoditizing chemotherapy agents like PEMFEXY.

2. Competitive Landscape

The chemo-oncology market is intensely competitive. PEMFEXY faces competition from other antifolates such as methotrexate, as well as from newer targeted therapies and immunotherapeutic agents. The emergence of checkpoint inhibitors like pembrolizumab and nivolumab has altered treatment algorithms, sometimes relegating chemotherapy to earlier lines or adjunct roles.

Generic versions forecasted post-patent expiry will exert downward pressure on prices. Meanwhile, customized combination therapies may either cannibalize PEMFEXY’s market share or open new avenues for combination regimens.

3. Regulatory and Pricing Pressures

Pricing pressures stem from payers seeking cost-effective treatments, especially within the U.S. healthcare system. Value-based pricing models and cost-effectiveness analyses influence reimbursement levels, impacting profitability. Additionally, the introduction of biosimilars and generics following patent expirations threatens to diminish revenue streams significantly.

Regulatory bodies’ evolving approval criteria, emphasizing real-world effectiveness and safety data, may also influence the drug’s market expansion or contraction.

4. Market Access and Distribution Strategies

Market access strategies—such as geographic expansion, patient assistance programs, and formulary negotiations—dictate PEMFEXY's penetration. Companies are increasingly adopting data-driven approaches to demonstrate clinical benefit and cost-effectiveness to secure favorable formulary positions.

Distribution channels, including hospital formularies, specialty clinics, and pharmacy networks, are critical to ensuring steady availability and uptake, especially in low- and middle-income countries.

Financial Trajectory

1. Revenue Projections

Current revenue for PEMFEXY is stable within its primary markets but faces a future decline upon patent expiries. Short-term revenues are anticipated to grow modestly due to increased adoption in combination therapies and expanded indications, such as earlier-stage lung cancer.

Long-term projections suggest a decline, contingent on the timing of generic entry. However, strategic initiatives like drug repositioning, new combination regimens, or niche market targeting could mitigate decline trajectories.

2. Impact of Patent Expiry

Patent cliffs pose significant risks. The expiration period varies by jurisdiction, with U.S. and European markets facing patent expiry within the next 3-5 years. Post-patent, generic entries are expected heavily to influence pricing and sales volumes, leading to a sharp revenue reduction if no new indications or formulations are introduced.

3. R&D and Lifecycle Management

Investments in clinical trials for novel formulations—such as nanoparticle delivery systems or oral versions—could extend the commercial viability. Additionally, pursuing new therapeutic niches or combination regimens might foster lifecycle extension and revenue diversification.

4. Strategic Partnerships and Market Expansion

Collaborations with regional distributors and licensing agreements in emerging markets can open new revenue channels. These markets often offer growth opportunities due to increasing cancer burdens and limited competition from advanced therapies.

Future Outlook and Growth Drivers

• Emerging Indications: Expansion into earlier lines of therapy or maintenance settings could elevate usage.
• Combination Regimens: Synergistic use with immunotherapies or targeted agents could rejuvenate sales.
• Market Expansion: Entry into emerging markets with rising cancer prevalence and increasing healthcare expenditure.
• Lifecycle Extensions: Developing new formulations and dosing strategies to maintain market relevance.

Conversely, the rapid advent of immunotherapies for NSCLC and mesothelioma may challenge PEMFEXY’s prominence. As such, companies are likely to invest selectively, balancing revenue from existing indications with innovation pathways.

Risks and Challenges

• Accelerated Biosimilar Entry: Patent expirations may lead to aggressive generic competition, pressuring prices.
• Changing Treatment Paradigms: The shift towards immunotherapy could marginalize traditional chemotherapy agents.
• Pricing and Reimbursement Constraints: Cost containment policies threaten higher-margin revenues.
• Regulatory Hurdles: Approval delays or restricted indications might impede market expansion.

Conclusion

PEMFEXY’s market dynamics are characterized by a mature product facing imminent patent cliffs, with revenues influenced heavily by competitive pressures and industry innovation. While current demand remains steady within its approved indications, future growth hinges on strategic differentiation through combination therapies, lifecycle management, and geographic expansion. The financial trajectory warns of decline post-patent expiry, emphasizing the necessity of adaptive strategies to sustain relevance and profitability.

Key Takeaways

• Market stability is challenged by patent expiration and emerging treatment alternatives. Strategic planning for lifecycle extension and indication expansion is critical.
• Competitive pressures from biosimilars and generics will likely reduce pricing power post-patent expiry. Cost-effectiveness assessments may further constrain revenues.
• Innovative combination therapies and new formulations could mitigate revenue decline. Focus on clinical and regulatory pathways for alternative indications enhances prospects.
• Emerging markets provide growth opportunities but require tailored access strategies. Addressing regional healthcare infrastructure and reimbursement landscapes is essential.
• Adapting to evolving treatment paradigms is vital. Emphasizing personalized medicine and integrating PEMFEXY into combination regimens can secure its relevance.

FAQs

1. When is PEMFEXY expected to face significant generic competition?
Patent protections are expected to expire within 3 to 5 years in key markets like the U.S. and Europe, after which biosimilar versions are likely to enter, intensifying price competition.

2. How is the shift toward immunotherapy affecting PEMFEXY’s market share?
Immunotherapies, such as pembrolizumab, have become preferred options for certain NSCLC and mesothelioma cases, leading to reduced reliance on chemotherapy agents like PEMFEXY in first-line settings, impacting its long-term growth.

3. Are there ongoing clinical efforts to expand PEMFEXY’s indications?
Yes, ongoing trials explore its use in combination with emerging agents, in earlier stages of lung cancer, and for new malignancies, aiming to broaden the drug’s therapeutic footprint.

4. What strategies can extend PEMFEXY’s commercial lifespan?
Lifecycle extension strategies include developing novel formulations, securing approval for new indications, and fostering market expansion in emerging territories.

5. What are the primary financial risks for PEMFEXY’s manufacturers?
The chief risks include rapid patent expiration leading to biosimilar competition, declining treatment preferences due to immunotherapy advances, and adverse regulatory or reimbursement policies impacting profitability.

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Sources:

[1] FDA Approval Announcements, 2010-2022.
[2] Market reports on oncology therapeutics, 2022.
[3] Industry analysis on biosimilar impact, 2023.
[4] Clinical trial databases and recent publications.
[5] Healthcare policy updates relevant to drug pricing and reimbursement.