Suppliers and packagers for generic pharmaceutical drug: IMATINIB MESYLATE

IMATINIB MESYLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Shorla Oncology	IMKELDI	imatinib mesylate	SOLUTION;ORAL	219097	NDA	Shorla Oncology Inc.,	81927-201-01	140 mL in 1 BOTTLE (81927-201-01)	2024-12-19
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588	NDA	Novartis Pharmaceuticals Corporation	0078-0401-34	90 TABLET in 1 BOTTLE (0078-0401-34)	2001-05-15
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588	NDA	Novartis Pharmaceuticals Corporation	0078-0649-13	3 BLISTER PACK in 1 CARTON (0078-0649-13) / 10 TABLET in 1 BLISTER PACK (0078-0649-26)	2014-12-23
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588	NDA	Novartis Pharmaceuticals Corporation	0078-0649-30	30 TABLET in 1 BOX, UNIT-DOSE (0078-0649-30)	2014-12-23

Suppliers for the Pharmaceutical Drug: Imatinib Mesylate

Last updated: July 28, 2025

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Introduction

Imatinib mesylate, commercially known as Gleevec or Glivec, is a targeted cancer therapy that revolutionized the treatment of chronic myeloid leukemia (CML) and other malignancies. Since its discovery, multiple innovative pharmaceutical manufacturers and generic suppliers worldwide have competed to produce and supply this critical medication. Understanding the landscape of imatinib mesylate suppliers provides insights into supply chain robustness, pricing dynamics, and availability, critical for healthcare providers, regulators, and pharmaceutical investors.

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Market Overview of Imatinib Mesylate

Imatinib mesylate was originally developed by Novartis and approved by the U.S. Food and Drug Administration (FDA) in 2001. Its mechanism involves inhibiting the BCR-ABL tyrosine kinase, pivotal in CML pathogenesis. As a blockbuster drug, its demand spans decades, prompting manufacturing proliferation. The drug is available both as branded formulations and through multiple generics, expanding access worldwide.

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Original and Patent-Holding Manufacturers

Novartis AG

• Role & Market Position
  Novartis retains patent rights and continues manufacturing the branded version, Gleevec/Glivec. The company maintains a significant share of the market, especially in developed economies. Novartis’s manufacturing facilities adhere to stringent Good Manufacturing Practices (GMP), ensuring product quality and supply security.

• Supply Strategy
  Decades of exclusivity allowed Novartis to establish a well-established supply chain. As patents expired or faced challenges in various jurisdictions, Novartis engaged in licensing agreements and expansions to remain competitive.

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Generic Manufacturers and Suppliers

Following patent expiration in numerous markets, multiple generics manufacturers have entered the market. This proliferation has enhanced supply, reduced prices, and increased geographic access.

Key Generic Suppliers Include:

1. Sandoz (Novartis division)

   • The initial producer of generic imatinib following patent expiry in the U.S. (2016).
   • Supplies both branded and generic versions globally, highlighting a strategy to capture market share through extensive manufacturing capabilities and regulatory approvals.

2. Sun Pharmaceutical Industries Ltd.

   • Indian pharmaceutical giant with FDA-approved imatinib manufacturing.
   • Offers affordable generic options in India, Southeast Asia, and other emerging markets.

3. Hetero Drugs Limited

   • An Indian generic manufacturer with multiple regulatory approvals (USFDA, UK MHRA).
   • Supplies imatinib in various formulations, including 100 mg and 400 mg tablets.

4. Dr. Reddy’s Laboratories

   • Approved in numerous countries, with a focus on providing cost-effective generics.
   • Utilizes a global manufacturing footprint to expand access.

5. Natco Pharma

   • Has obtained approvals for generic imatinib in several markets, primarily targeting low- and middle-income economies.

6. Mylan (now part of Viatris)

   • Previously marketed a generic version in various countries, including the U.S., before merging into Viatris.
   • Offers differentiated supply options through international partnerships.

Emerging Suppliers

Emerging markets, including China, Eastern Europe, and Latin America, have seen local manufacturers obtaining regulatory approval for imatinib. These suppliers aim to meet local demands amid global shortages or price pressures.

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Regulatory Approvals and Market Access

Suppliers achieve market entry through rigorous regulatory pathways, including:

• FDA Approval (United States): Ensures manufacturing quality and product efficacy.
• EMA Authorization (European Union): Facilitates access within European markets.
• PMDA Approvals (Japan): Ensures compliance with Japanese standards.
• WHO PQ Certification: Enables suppliers to distribute in developing countries, expanding access.

Post-patent expiration has led to multiple suppliers obtaining generic approvals, often with accelerated pathways or reliance on bioequivalence studies.

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Supply Chain Dynamics & Challenges

The imatinib supply chain faces various challenges, including:

• Manufacturing capacity constraints in emerging markets, affecting supply during global crises.
• Regulatory disparities across countries potentially delaying approval or distributing counterfeit products.
• Pricing pressures from international health agencies aiming to improve affordability.
• Quality assurance remains critical; substandard products proliferate in unregulated markets.

Despite these challenges, alliances between patent holders and local manufacturers foster wider access, particularly in low- and middle-income countries.

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Key Markets and Leading Suppliers

Country/Region	Leading Supplier(s)	Market Specifics
United States	Sandoz, Mylan (Viatris)	Predominantly generics post-patent expiry, extensive regulatory oversight
Europe	Novartis (branded), Sandoz, Teva, Mylan	Availability of both branded and generic options
India	Sun Pharma, Dr. Reddy’s, Hetero	Significant generic manufacturing hub, lower prices
China	Fosun, Shanghai ChemPartner	Increasing local manufacturing, targeting domestic and export markets
Latin America & Africa	Local distributors, WHO prequalified suppliers	Growing infrastructure, reliance on WHO PQ-certified generics

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Future Outlook and Supply Security Considerations

The imatinib market is expected to remain competitive, with multiple suppliers ensuring supply security. Nonetheless, ongoing patent litigations, regulatory shifts, and technological advancements could influence supplier landscape dynamics. Initiatives such as voluntary licensing by patent holders, including Novartis, are vital in broadening access.

Further, biosimilar and innovative therapies may reshape the treatment paradigm, impacting imatinib demand and supplier engagement strategies.

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Key Takeaways

• Diverse Supplier Base: The imatinib mesylate market spans multiple global manufacturers, with original patent holders controlling branded supplies and numerous generics redressing market access in developing countries.
• Patent Expirations Fuel Generics: Market entry of generics has significantly driven down prices and bolstered supply volumes. Indian manufacturers dominate the space, leveraging cost-effective production.
• Quality & Regulatory Compliance: Suppliers with rigorous regulatory approvals (FDA, EMA, WHO) dominate high-income markets, ensuring product quality and safety.
• Supply Chain Risks & Resilience: While the supply chain is mature, vulnerabilities remain amid global crises, emphasizing the importance of diversified sourcing and local manufacturing capacity.
• Access & Affordability: Initiatives like voluntary licensing and patent pooling are crucial in expanding availability, especially in low-resource settings.

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FAQs

1. Who are the leading suppliers of generic imatinib mesylate globally?
   Sandoz (a Novartis division), Sun Pharma, Dr. Reddy’s, Hetero, Natco, and Viatris (formerly Mylan) are among the top generic suppliers, with substantial market shares in various regions.

2. Can I find imatinib mesylate manufactured in my country?
   Likely, especially if your country hosts licensed generic manufacturers authorized through stringent regulatory bodies or WHO prequalification. Local production aims to meet regional demand and reduce dependency on imports.

3. What are the main challenges facing imatinib supply?
   Challenges include manufacturing capacity constraints during crises, regulatory delays, counterfeit risks, and quality assurance, particularly in unregulated markets.

4. Are biosimilars or alternative therapies affecting imatinib's market?
   While biosimilars are emerging, current imatinib formulations remain standard care for CML. Newer therapies are being explored for resistant cases but have not significantly displaced imatinib yet.

5. How does patent status influence the supply landscape?
   Patent expirations in key markets opened the door for numerous generics, vastly increasing supply options and affordability. Patent protections currently limit generic competition in certain regions, maintaining higher prices for branded versions.

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References

1. [1] Novartis AG. Gleevec (imatinib) overview and manufacturing data. 2022.
2. [2] FDA Drug Approvals and Generic Drug Pathways. 2021.
3. [3] World Health Organization Prequalification Program. List of Qualified Suppliers. 2022.
4. [4] IMS Health Data on Global Imatinib Market Share. 2022.
5. [5] Patent Litigation and Market Access Reports. European Patent Office. 2022.