PEMETREXED DISODIUM - Generic Drug Details

What are the generic sources for pemetrexed disodium and what is the scope of freedom to operate?

Pemetrexed disodium is the generic ingredient in three branded drugs marketed by Lilly, Accord Hlthcare, Amneal, Apotex, Baxter Hlthcare Corp, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, Nang Kuang Pharm Co, Pharmobedient, Prinston Inc, Qilu Pharm Hainan, Reliance Life, Zydus Pharms, Shilpa, and Sandoz, and is included in twenty-five NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pemetrexed disodium has one patent family member in one country.

There are twenty-two drug master file entries for pemetrexed disodium. Twenty-four suppliers are listed for this compound.

Summary for PEMETREXED DISODIUM

International Patents:	1
US Patents:	1
Tradenames:	3
Applicants:	21
NDAs:	25
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	111
Patent Applications:	7,910
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEMETREXED DISODIUM
What excipients (inactive ingredients) are in PEMETREXED DISODIUM?	PEMETREXED DISODIUM excipients list
DailyMed Link:	PEMETREXED DISODIUM at DailyMed

Recent Clinical Trials for PEMETREXED DISODIUM

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

Sponsor	Phase
Shanghai Chest Hospital	PHASE2
BeBetter Med Inc	PHASE2
Merck Sharp & Dohme Corp.	Phase 3

See all PEMETREXED DISODIUM clinical trials

Pharmacology for PEMETREXED DISODIUM

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

Medical Subject Heading (MeSH) Categories for PEMETREXED DISODIUM

Antineoplastic Agents

Enzyme Inhibitors

Folic Acid Antagonists

Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PEMETREXED DISODIUM

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PEMETREXED DISODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALIMTA	For Injection	pemetrexed disodium	750 mg/vial	021462	1	2016-10-06
ALIMTA	For Injection	pemetrexed disodium	1000 mg/vial	021462	1	2012-06-27
ALIMTA	For Injection	pemetrexed disodium	100 mg/vial	021462	1	2008-07-01
ALIMTA	For Injection	pemetrexed disodium	500 mg/vial	021462	2	2008-02-04

US Patents and Regulatory Information for PEMETREXED DISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	PEMETREXED DISODIUM	pemetrexed disodium	SOLUTION;INTRAVENOUS	214408-001	Jul 19, 2022		DISCN	Yes	No
Amneal	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	210047-002	May 8, 2023		DISCN	No	No
Fresenius Kabi Usa	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	090384-002	May 25, 2022	AP	RX	No	No
Zydus Pharms	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	214073-002	May 25, 2022	AP	RX	No	No

Expired US Patents for PEMETREXED DISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-002	Sep 7, 2007
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004

International Patents for PEMETREXED DISODIUM

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016151365

Supplementary Protection Certificates for PEMETREXED DISODIUM

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

Market Dynamics and Financial Trajectory for Pemetrexed Disodium

Last updated: July 27, 2025

Introduction

Pemetrexed disodium, marketed primarily under the brand name Alimta, is a chemotherapeutic agent used predominantly in the treatment of malignant pleural mesothelioma and nonsquamous non-small cell lung cancer (NSCLC). As an antifolate agent, it inhibits several key enzymes involved in purine and pyrimidine synthesis, disrupting cancer cell proliferation. Over the past decade, the drug’s market landscape has undergone significant evolution driven by clinical advancements, regulatory developments, and competitive dynamics. This analysis explores the current market environment, forecasted financial trajectory, and critical factors shaping the future of pemetrexed disodium.

Market Overview and Current Landscape

Global Market Size and Growth Drivers

The global oncology therapeutic market is on an upward trajectory, projected to reach approximately USD 220 billion by 2027, with targeted and immuno-oncology agents leading growth trends. Pemetrexed disodium occupies a niche within this expansive market, primarily serving the lung and mesothelioma segments. As per IQVIA, the global NSCLC treatment market alone is expected to grow at a CAGR of 7% from 2021 to 2028 [1].

Major growth drivers include:

• Increasing incidence of lung cancers, particularly NSCLC, attributed to smoking, pollution, and aging demographics.
• Rising global awareness and adoption of combination chemotherapy that includes pemetrexed.
• Expandable indications, including its emerging role in mesothelioma management.
• New geographic markets, notably Asia-Pacific, exhibiting rapid market penetration due to rising cancer prevalence and improved healthcare infrastructure.

Regulatory and Patent Considerations

Pemetrexed disodium’s patent exclusivity era concluded in key markets like the U.S. and Europe around 2019, opening the door for biosimilar and generic competition. This shift has exerted downward pressure on prices but also increased accessibility, thus expanding potential market volume. However, patent litigations and exclusivity extensions in specific regions continue to influence commercial dynamics.

Competitive Landscape

The competitive landscape is characterized by:

• Generic Rivalry: Several manufacturers now produce pemetrexed generics, reducing healthcare costs but pressuring branded formulations' margins.
• Combination Regimens: Pemetrexed is often used with platinum-based agents, with combinations evolving based on latest clinical data.
• Emerging Agents: Novel targeted therapies and immunotherapies are challenging the dominance of chemotherapy agents, potentially affecting pemetrexed’s long-term sales.

Clinical and Regulatory Advances

Recent studies exploring pemetrexed's synergistic effects with immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab) are expanding its therapeutic potential. Regulatory approvals for combination regimens are expected to boost demand further, especially in regions adopting personalized medicine.

Market Challenges and Opportunities

Challenges

• Price Erosion: The entry of biosimilars and generics diminishes revenue streams for original manufacturers.
• Competitive Therapies: The advent of immunotherapy agents such as PD-1/PD-L1 inhibitors is shifting treatment paradigms away from chemotherapy.
• Regulatory Hurdles: Variability in approval processes across countries can delay market expansion.

Opportunities

• Expanding Indications: Research into pemetrexed's efficacy in other cancers could open additional revenue streams.
• Combination Therapies: Strategic partnerships and clinical trials combining pemetrexed with immunotherapies can create a sustainable growth pathway.
• Emerging Markets: Expansion into untapped markets, particularly in Asia-Pacific and Latin America, offers significant growth potential.

Financial Trajectory Forecast

Revenue Projections

Pre-Patent expiry, pemetrexed saw consistent growth, with peak sales in 2018 estimated at USD 1.5 billion globally [2]. Post-expiry, revenues declined due to generic competition, with recent estimates indicating a stabilizing trend. The global market value is projected to decline at a CAGR of approximately 4% from 2020 to 2025, reaching around USD 1.2 billion by 2025 [3].

However, if manufacturers leverage combination therapies and expand indications, a modest recovery and segmentation are plausible. For instance:

• The potential approval of pemetrexed in mesothelioma in emerging markets.
• Growth from combination regimens incorporating immunotherapy agents, which are projected to compose about 30% of the NSCLC treatment market by 2025.

Cost and Pricing Dynamics

Pricing pressure due to generics has led to significant erosion of per-unit revenue, especially in mature markets. Nonetheless, differentiated formulations or combination products with patent protection could sustain premium pricing.

Profitability Outlook

Gross margins for pemetrexed drugs have declined from approximately 60% pre-patent expiry to below 40% in regions with widespread generic competition. Future profitability hinges on:

• Market share retention through clinical differentiation.
• Cost containment strategies.
• Diversification into combination therapies and new indications.

Future Market Drivers

Innovation and Clinical Development

Ongoing research into pemetrexed’s efficacy in combination with immunotherapies and targeted agents remains a critical vector for growth. Positive phase 3 trial outcomes could lead to expanded label indications, reinforcing market presence.

Geopolitical and Economic Factors

Emerging economies with rising cancer burden represent significant untapped markets. Strategic alliances, partnerships, and licensing can facilitate market entry with minimal regulatory friction.

Healthcare Policy and Reimbursement

Shifts towards value-based care models and government-sponsored pricing reforms may influence profitability. Ensuring cost-effectiveness through biosimilars can both expand access and improve market share.

Conclusion

Pemetrexed disodium’s financial trajectory is increasingly influenced by patent expiration, biosimilar competition, and evolving clinical treatment paradigms. While original sales have declined, strategic deployment in combination therapies and international expansion present avenues for sustained growth. The next phase hinges on continued innovation, regulatory agility, and market diversification.

Key Takeaways

• The global pemetrexed market faces significant pricing pressures due to biosimilar entry, but combination therapies and new indications offer growth opportunities.
• Expansion into emerging markets and clinical trials exploring novel combinations can drive revenue stabilization.
• Innovating beyond traditional indications and leveraging partnerships in immunotherapy combinations will be essential.
• Cost management and strategic pricing will be critical in maintaining profitability amidst declining per-unit revenues.
• Regulatory flexibility and evidence-based positioning can optimize market access and reimbursement prospects.

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FAQs

1. What factors have primarily contributed to the decline in pemetrexed’s revenue post-patent expiry?
Generic competition, biosimilar entries, and price erosion in mature markets have significantly reduced revenue streams, compounded by shifts toward immunotherapy over chemotherapy.

2. How is pemetrexed being utilized in combination therapies to sustain market relevance?
Pemetrexed is increasingly combined with immune checkpoint inhibitors like pembrolizumab, expanding its role in first-line treatment regimens for NSCLC, which can boost demand despite generic price competition.

3. Which emerging markets hold the most promise for pemetrexed’s future growth?
Asia-Pacific, Latin America, and parts of Africa represent promising growth opportunities due to rising cancer incidence, improving healthcare access, and less mature competition landscapes.

4. What are the key clinical developments that could impact pemetrexed’s market share?
Positive trial results for pemetrexed in new indications or in combination with targeted therapies, along with regulatory approvals, will likely enhance its market share and therapeutic relevance.

5. How do biosimilars affect the profitability and pricing strategies of original pemetrexed manufacturers?
Biosimilar entry reduces pricing power, diminishes profit margins, and necessitates innovation, cost reduction, or premium offerings such as combination regimens to maintain competitiveness.

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References

[1] IQVIA, “Global Oncology Market Report,” 2021.
[2] EvaluatePharma, “Pemetrexed Sales and Market Share Data,” 2018.
[3] MarketResearchFuture, “Oncology Drugs Market Forecast,” 2020.