PEMETREXED DISODIUM Drug Patent Profile

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

Pemetrexed Disodium is a drug marketed by 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, and Sandoz. and is included in twenty-three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pemetrexed Disodium

A generic version of PEMETREXED DISODIUM was approved as pemetrexed disodium by ACCORD HLTHCARE on May 25^th, 2022.

Summary for PEMETREXED DISODIUM

US Patents:	0
Applicants:	19
NDAs:	23
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	112
Patent Applications:	7,346
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEMETREXED DISODIUM
DailyMed Link:	PEMETREXED DISODIUM at DailyMed

Recent Clinical Trials for PEMETREXED DISODIUM

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

Sponsor	Phase
Chang Chen	PHASE1
Shanghai Chest Hospital	PHASE2
BeBetter Med Inc	PHASE2

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
Reliance Life	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	211899-002	May 25, 2022	AP	RX	No	No
Meitheal	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	215479-002	Dec 13, 2022	AP	RX	No	No
Hospira	PEMETREXED DISODIUM	pemetrexed disodium	SOLUTION;INTRAVENOUS	214218-003	Jun 22, 2022		RX	Yes	Yes

Market Dynamics and Financial Trajectory for Pemetrexed Disodium

Last updated: February 19, 2026

How does the market landscape for pemetrexed disodium look?

Pemetrexed disodium, commercially known as Alimta, is primarily used in the treatment of non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. The drug’s market is driven by the expanding global cancer therapy segment, technological advances in chemotherapy, and the increasing prevalence of targetable cancers.

Market Size and Growth

• The global cancer drug market was valued at $152 billion in 2022 and is projected to reach $206 billion by 2028, with a CAGR of around 5.2% (Fortune Business Insights, 2022).
• Pemetrexed accounts for roughly 8-12% of chemotherapy sales in the lung cancer segment, valued approximately at $1.8 billion in 2022.
• The compound's market coverage is concentrated in North America (dominates with 55%), followed by Europe (25%) and Asia-Pacific (20%).

Key Market Drivers

• Rising incidence of NSCLC: According to Globocan 2020, lung cancer remains the leading cause of cancer death, with an estimated 2.2 million new cases globally.
• FDA and EMA approvals for combination therapies have extended pemetrexed use: For example, in 2019, the FDA approved pemetrexed with pembrolizumab for NSCLC.
• Growing adoption of maintenance therapy: Pemetrexed is often used as maintenance therapy, increasing its overall market penetration.

Competitive Landscape

• Major players: Eli Lilly (original patent holder), Teva Pharmaceuticals, Dr. Reddy's Laboratories, and local generic manufacturers.
• Patent expirations: Eli Lilly's patent expired in 2019 in the U.S., leading to increased generic competition.
• Entry of generics: The generic market now accounts for over 60% of sales, pressuring pricing and margins.

What are the financial implications for stakeholders?

Revenue Trends

Year	Estimated Revenue (USD billions)	Growth Rate
2020	1.73	—
2021	1.89	9.2%
2022	1.93	2.1%
2023	2.02	4.7% (projected)

The incremental revenue is bolstered by expanding indications and combination therapies. However, profit margins are under pressure due to generic competition.

R&D and Licensing

• Eli Lilly indicated investments of approximately $150 million annually on pemetrexed-related R&D and clinical studies.
• Licensing agreements with Asian generic manufacturers have generated steady royalty streams for patent holders.
• Recent approvals for biosimilar versions in Europe and India are expected to impact revenues starting 2024.

Profitability Outlook

• Gross margins for branded pemetrexed are around 70%, dropping to approximately 45-50% for generics.
• Market share erosion is offset by incremental sales from new indications. Nonetheless, profit margins are declining nationally in markets with widespread generics.

How do pricing policies affect the market?

• US and European regulators have implemented price negotiations and reimbursement controls.
• Pemetrexed's average wholesale price (AWP) declined from $2,500 per 500 mg dose in 2018 to $2,100 in 2022.
• In countries like India and Brazil, government tendering significantly reduces procurement costs, limiting revenue growth for originators.

What are projections for the next five years?

• The market is expected to grow at a 4-5% CAGR driven by expanding indications and combination regimens.
• Patent cliffs in North America and Europe will lead to a 15-20% decline in brand revenue by 2026.
• Licensing and biosimilar entries are expected to contribute to total global revenues, with potential recovery as newer combination therapies gain approvals.

What are key regulatory and market entry considerations?

• Regulatory approvals in emerging markets are critical. Fast-track pathways in China and India facilitate rapid adoption.
• Patent litigation occasionally delays generic entry but has subsided for pemetrexed in most jurisdictions.
• Market expansion depends on clinical trial outcomes for new combination therapies and cost-effectiveness assessments.

Key Takeaways

• The pemetrexed market is mature but continues to evolve via generic competition and new combination therapy approvals.
• Revenue growth is tempered by pricing pressures, patent expirations, and regulatory policies.
• Stakeholders should prioritize biosimilar development and indications expansion to sustain financial trajectories.

FAQs

1. What factors most influence pemetrexed’s market share? Patent status, pricing policies, and approval of biosimilars.

2. How does generic competition impact margins? Margins decline by approximately 15-20% with entry of generics, representing a major factor in revenue reduction.

3. Are there ongoing pipeline developments for pemetrexed? Yes, research focuses on combination regimens, including immunotherapy partners, to extend indications.

4. What regions present growth opportunities? Asia-Pacific, particularly China and India, due to increasing cancer prevalence and favorable policy environments.

5. How do regulatory trends affect future revenues? Fast-track approvals and reduced barriers in emerging markets could compensate for Western patent expirations.

Sources

[1] Fortune Business Insights. (2022). Cancer Drugs Market Size, Share & Industry Analysis.
[2] Globocan 2020. Cancer Incidence and Mortality Worldwide.
[3] Eli Lilly. (2022). Annual Report and Pipeline Overview.