Suppliers and packagers for pemetrexed

pemetrexed

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis	PEMETREXED	pemetrexed	SOLUTION;INTRAVENOUS	208419	NDA	Teva Pharmaceuticals, Inc.	0480-4514-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4514-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2022-05-31
Actavis	PEMETREXED	pemetrexed	SOLUTION;INTRAVENOUS	208419	NDA	Teva Pharmaceuticals, Inc.	0480-4515-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4515-01) / 40 mL in 1 VIAL, SINGLE-DOSE	2022-05-31
Actavis	PEMETREXED	pemetrexed	SOLUTION;INTRAVENOUS	208419	NDA	Teva Pharmaceuticals, Inc.	0480-4516-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4516-01) / 4 mL in 1 VIAL, SINGLE-DOSE	2022-06-01
Shilpa	PEMETREXED	pemetrexed disodium	SOLUTION;INTRAVENOUS	215179	NDA	Shilpa Medicare Limited	63759-3048-1	1 VIAL in 1 CARTON (63759-3048-1) / 10 mL in 1 VIAL	2024-01-01

Pemetrexed Suppliers and Patent Landscape

Last updated: February 19, 2026

This analysis identifies key suppliers of Pemetrexed and examines the patent landscape impacting its market. The focus is on active pharmaceutical ingredients (APIs) and finished dosage forms, with an emphasis on companies holding manufacturing capabilities and relevant intellectual property.

Who are the Primary API Suppliers for Pemetrexed?

The supply chain for Pemetrexed is characterized by a concentration of API manufacturers, primarily located in India and China. These suppliers are critical for both originator and generic drug production.

• Major API Manufacturers:

  • Sun Pharmaceutical Industries Ltd.: A significant player in the Indian pharmaceutical market, Sun Pharma is a known supplier of Pemetrexed API. [1]
  • Dr. Reddy's Laboratories Ltd.: Another leading Indian pharmaceutical company, Dr. Reddy's also produces and supplies Pemetrexed API. [1]
  • Lupin Limited: Lupin is a global pharmaceutical company with a strong API manufacturing base, including Pemetrexed. [1]
  • Cipla Ltd.: Cipla is a well-established Indian pharmaceutical firm that manufactures Pemetrexed API. [1]
  • Zydus Lifesciences Limited (formerly Cadila Healthcare): This Indian company is also involved in the production of Pemetrexed API. [1]
  • Hospira, Inc. (now part of Pfizer): While originally a significant player, Hospira's Pemetrexed manufacturing has transitioned under Pfizer's broader operations. [2]
  • Teva Pharmaceutical Industries Ltd.: Teva is a global generics leader and a key producer of Pemetrexed API and finished formulations. [3]
  • Fresenius Kabi AG: This German healthcare company is known for its infusion therapies and generic injectable products, including Pemetrexed. [4]
  • Key Chinese Manufacturers: Several Chinese companies are active in API production, though specific company names for Pemetrexed may vary and require direct sourcing. These often supply to global formulators.

• Production Capacity and Geography:

  • India is a dominant hub for Pemetrexed API production, leveraging its established API manufacturing infrastructure and cost efficiencies.
  • China also represents a significant manufacturing base, contributing to global supply.
  • Companies in Europe and North America also possess manufacturing capabilities, though often at a higher cost structure or focused on specific market segments.

What is the Patent Landscape for Pemetrexed?

The patent landscape for Pemetrexed is complex, involving composition of matter patents, formulation patents, polymorph patents, and process patents. The expiry of key patents has opened the market to generic competition.

• Composition of Matter Patent:

  • The primary composition of matter patent for Pemetrexed (2-amino-4-[N-(4,7-dihydro-1-methyl-7-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)amino]benzoyl]-L-glutamic acid) was held by Eli Lilly and Company.
  • US Patent 5,344,932: Filed on April 28, 1993, and issued on September 6, 1994. This patent covered the Pemetrexed molecule itself. [5]
  • Expirations: This patent expired globally, paving the way for generic development. The US expiration date was September 6, 2011, with extensions. [5]

• Formulation Patents:

  • Eli Lilly also secured patents related to specific formulations of Pemetrexed, particularly its disodium salt form.
  • US Patent 7,485,641: Filed on June 21, 2004, and issued on February 3, 2009. This patent covered a specific pharmaceutical composition and method of treatment. [6]
  • US Patent 8,017,610: Filed on October 13, 2005, and issued on September 13, 2011. This patent relates to an improved process for preparing Pemetrexed disodium. [7]
  • Challenges and Expirations: Generic companies have successfully challenged or worked around many of these formulation patents. The effective market exclusivity granted by these patents has largely concluded in major markets.

• Polymorph Patents:

  • Different crystalline forms (polymorphs) of Pemetrexed disodium can have different physical properties (e.g., solubility, stability). Patents covering specific, advantageous polymorphs were pursued.
  • US Patent 7,732,474: Issued to Eli Lilly on June 8, 2010. This patent covers specific crystalline forms of Pemetrexed disodium. [8]
  • Generic Strategies: Generic manufacturers often develop their own non-infringing crystalline forms or demonstrate that their processes do not infringe on existing polymorph patents.

• Process Patents:

  • Patents related to novel or improved methods of synthesizing Pemetrexed API. These can offer a competitive advantage by reducing costs or improving purity.
  • Companies continuously file and defend process patents to protect their manufacturing methods. Identifying all active process patents requires extensive patent searching.

• Patent Litigation:

  • The Pemetrexed market has been subject to significant patent litigation, particularly in the United States. Generic companies have filed Paragraph IV certifications challenging Eli Lilly's patents, leading to Hatch-Waxman litigation. [9]
  • Key litigation has involved challenges to formulation and polymorph patents, with outcomes dictating the timeline for generic market entry.

• Market Exclusivity and Generic Entry:

  • Following the expiry of key patents and successful patent challenges, generic versions of Pemetrexed (often marketed as Pemetrexed disodium for injection) have entered the market.
  • ANDA Approvals: The U.S. Food and Drug Administration (FDA) has approved multiple Abbreviated New Drug Applications (ANDAs) for generic Pemetrexed, signaling the availability of cost-effective alternatives. [10]
  • Impact on Pricing: Generic entry has led to a substantial decrease in Pemetrexed prices, a critical factor for healthcare systems and patient access.

What are the Key Finished Dosage Form Manufacturers?

Finished dosage form manufacturers are responsible for formulating the API into a usable drug product, such as Pemetrexed disodium for injection.

• Originator:

  • Eli Lilly and Company: Markets Pemetrexed under the brand name Alimta®. [2] Lilly holds the original approvals and established manufacturing processes.

• Major Generic Manufacturers:

  • Teva Pharmaceutical Industries Ltd.: A leading global generics company, Teva manufactures and markets Pemetrexed. [3]
  • Sun Pharmaceutical Industries Ltd.: In addition to API, Sun Pharma produces generic finished dosage forms of Pemetrexed. [1]
  • Dr. Reddy's Laboratories Ltd.: A significant player in generics, Dr. Reddy's offers Pemetrexed formulations. [1]
  • Fresenius Kabi AG: Specializes in generic injectable drugs, including Pemetrexed. [4]
  • Viatris Inc. (formed by Mylan and Upjohn): Viatris is a key global supplier of generics, including Pemetrexed. [11]
  • Accord Healthcare Ltd.: Part of the Intas Pharmaceuticals group, Accord is a significant supplier of generics in various markets.
  • Hospira (Pfizer): Continues to supply Pemetrexed products, particularly in hospital settings. [2]
  • Aurobindo Pharma Ltd.: Another major Indian pharmaceutical company with a broad generic portfolio, including Pemetrexed.

• Geographic Reach:

  • These companies operate globally, supplying Pemetrexed to markets in North America, Europe, Asia, and other regions.
  • Manufacturing sites are located in India, the United States, Europe, and other countries, adhering to regional regulatory standards.

How Do Regulatory Filings Impact Pemetrexed Supply?

Regulatory approvals are essential for any company seeking to manufacture and sell Pemetrexed API or finished drug products.

• ANDA Filings (USA):

  • Companies must submit ANDAs to the FDA for generic Pemetrexed. These filings demonstrate bioequivalence to the reference listed drug (Alimta®). [10]
  • The FDA's approval of ANDAs allows for the commercialization of generic Pemetrexed in the United States.

• MAA Filings (Europe):

  • In Europe, Marketing Authorisation Applications (MAAs) are submitted to the European Medicines Agency (EMA) or national competent authorities for approval of generic Pemetrexed.

• Global Approvals:

  • Similar regulatory processes exist in other major markets (e.g., Japan, Canada, Australia), requiring local approvals from health authorities.

• Manufacturing Site Inspections:

  • Regulatory bodies conduct rigorous inspections of manufacturing facilities for both API and finished drug products to ensure compliance with Good Manufacturing Practices (GMP).
  • A company's ability to maintain GMP compliance is crucial for continuous supply.

• Quality Standards:

  • Suppliers must adhere to strict quality standards for API purity, stability, and impurity profiles, as well as for the finished drug product.

Key Takeaways

• API Sourcing: India and China are the dominant regions for Pemetrexed API manufacturing, with companies like Sun Pharma, Dr. Reddy's, and Lupin being key suppliers.
• Patent Expiry: The expiration of Eli Lilly's core composition of matter and key formulation patents has enabled broad generic competition.
• Generic Market Entry: Numerous global pharmaceutical companies, including Teva, Fresenius Kabi, and Viatris, are established suppliers of generic Pemetrexed finished dosage forms.
• Regulatory Gatekeeping: FDA (ANDA) and EMA (MAA) approvals are critical prerequisites for market access, and GMP compliance is essential for ongoing supply.
• Price Compression: Generic competition has significantly reduced Pemetrexed pricing, impacting market dynamics and increasing patient access.

FAQs

What is the chemical name for Pemetrexed?

The chemical name for Pemetrexed is 2-amino-4-[N-(4,7-dihydro-1-methyl-7-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)amino]benzoyl]-L-glutamic acid.

What is the typical route of administration for Pemetrexed?

Pemetrexed is typically administered intravenously (IV) infusion.

What is the therapeutic class of Pemetrexed?

Pemetrexed is classified as an antifolate chemotherapy drug used in the treatment of certain types of cancer, notably non-small cell lung cancer and malignant pleural mesothelioma.

Are there any known significant impurities to monitor in Pemetrexed API?

Standard pharmaceutical impurity profiling is required, and specific impurities would be detailed in regulatory filings and pharmacopoeial monographs. Common impurities in API manufacturing can arise from starting materials, reagents, or degradation.

What is the current status of Pemetrexed patent protection in major markets?

Key composition of matter and formulation patents have expired in major markets such as the United States and Europe, allowing for generic market entry. However, companies may hold newer patents on specific manufacturing processes or polymorphs.

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Citations

[1] Financial reports and public disclosures of Indian pharmaceutical companies. (Specific filings vary by company and year). [2] Eli Lilly and Company. (2023). Alimta® (pemetrexed for injection) Prescribing Information. [3] Teva Pharmaceutical Industries Ltd. (Publicly available product information and financial reports). [4] Fresenius Kabi AG. (Publicly available product information). [5] U.S. Patent 5,344,932. (1994). [6] U.S. Patent 7,485,641. (2009). [7] U.S. Patent 8,017,610. (2011). [8] U.S. Patent 7,732,474. (2010). [9] U.S. Food and Drug Administration. (2023). Approved ANDAs for Pemetrexed. [10] Generic Pharmaceutical Association (GPhA). (Industry reports and data on generic drug approvals). [11] Viatris Inc. (Publicly available product information and financial reports).