IMATINIB MESYLATE - Generic Drug Details

What are the generic drug sources for imatinib mesylate and what is the scope of freedom to operate?

Imatinib mesylate is the generic ingredient in three branded drugs marketed by Novartis, Shorla Oncology, Amneal Pharms, Apotex, Chartwell Rx, Cspc Ouyi, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Hikma, Mylan, Natco Pharma Ltd, Novitium Pharma, Qilu Pharm Hainan, Shilpa, Sun Pharm, Teva Pharms Usa, and Zydus Pharms, and is included in nineteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imatinib mesylate has six patent family members in six countries.

There are thirty-four drug master file entries for imatinib mesylate. Twenty-one suppliers are listed for this compound.

Summary for IMATINIB MESYLATE

International Patents:	6
US Patents:	1
Tradenames:	3
Applicants:	18
NDAs:	19
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	367
Patent Applications:	3,106
Drug Prices:	Drug price trends for IMATINIB MESYLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMATINIB MESYLATE
What excipients (inactive ingredients) are in IMATINIB MESYLATE?	IMATINIB MESYLATE excipients list
DailyMed Link:	IMATINIB MESYLATE at DailyMed

See drug prices for IMATINIB MESYLATE

Recent Clinical Trials for IMATINIB MESYLATE

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

Sponsor	Phase
University of California, San Diego	PHASE1
Columbia University	PHASE1
United States Department of Defense	PHASE1

See all IMATINIB MESYLATE clinical trials

Pharmacology for IMATINIB MESYLATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for IMATINIB MESYLATE

Antineoplastic Agents

Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for IMATINIB MESYLATE

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IMATINIB MESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLEEVEC	Tablets	imatinib mesylate	100 mg and 400 mg	021588	1	2007-03-12

US Patents and Regulatory Information for IMATINIB MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	207586-002	Jul 13, 2018		DISCN	No	No
Eugia Pharma	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	212773-002	Jul 23, 2020	AB	RX	No	No
Sun Pharm	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	078340-002	Dec 3, 2015	AB	RX	No	No
Apotex	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	079179-001	Aug 5, 2016	AB	RX	No	No
Zydus Pharms	IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	210658-001	Apr 8, 2020	AB	RX	No	No

Expired US Patents for IMATINIB MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-001	May 10, 2001
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003

International Patents for IMATINIB MESYLATE

Country	Patent Number	Title	Estimated Expiration
Singapore	11202001720R
Australia	2018306149
World Intellectual Property Organization (WIPO)	2019021229
European Patent Office	3658190
Russian Federation	2020108342

Supplementary Protection Certificates for IMATINIB MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0564409	C00564409/01	Switzerland		PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
0564409	02C0012	France		PRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621
0564409	2002/005	Ireland		PRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012
0564409	SPC/GB02/016	United Kingdom		PRODUCT NAME: IMATINIB (INN I.E. NON INTELLECTUAL PROPRIETARY NAME) OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; REGISTERED: CH IKS-NR: 55807 20010621; UK SG(2001) D/292083 20011108
0564409	C300086	Netherlands		PRODUCT NAME: IMATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESILAAT; NATL. REGISTRATION NO/DATE: EU/1/01/198/001 - 006 20011107; FIRST REGISTRATION: CH IKS 55807 20010621

Market Dynamics and Financial Trajectory for Imatinib Mesylate

Last updated: February 19, 2026

What Are the Key Market Drivers for Imatinib Mesylate?

Imatinib mesylate, marketed as Gleevec by Novartis, is a targeted therapy class tyrosine kinase inhibitor (TKI). It addresses chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). The drug’s market is influenced by multiple factors:

• High efficacy and approval status: Since its FDA approval in 2001 for CML, imatinib has demonstrated sustained clinical benefits.
• Patent protection: Patents expired in some regions, but exclusivity periods have maintained competitive advantage initially.
• Growing prevalence of CML and GIST: Incidence rates in the U.S. are approximately 1–2 cases per 100,000 annually for CML; GIST accounts for 1-3% of gastrointestinal malignancies.
• Treatment adherence: Chronic therapy requires ongoing use, supporting long-term revenue streams.
• Development of generic versions: Entry of biosimilars and generics has begun to pressure prices and market share post-patent expiry.

Market Size and Revenue Trends

Year	Global Sales (USD billion)	CAGR (%)	Notes
2018	4.6	-	Peak prior to biosimilar entry
2020	4.2	-8.7	Slight decline, biosimilar competition emerging
2022	3.8	-9.5	Biosimilar bios march, price erosion

Source: IQVIA, 2023

How Has Patent and Regulatory Landscape Affected Market Dynamics?

• Patent expiry: Clarification of patent expiry varies by country:
  • U.S.: Patents expired in 2016, allowing biosimilar entries from 2018.
  • EU: Market exclusivity ended in 2017, leading to biosimilar approval.
• Biosimilar market entry: Several biosimilars have entered the market globally:
  • India: Multiple manufacturers launched biosimilars post-2018.
  • Europe: Approved biosimilars from companies like Cipla and Stada.
• Regulatory pathways: The biosimilar approval process under EMA and FDA are similar but involve distinct requirements, affecting timing and market entry.

Patent Expiry Timeline

Region	Patent Expiry Year	Biosimilar Entry Year	Impact
U.S.	2016	2018	Price competition increased two years post-expiry
EU	2017	2018-2019	Multiple biosimilar approvals

How Do Market Competition and Pricing Strategies Evolve?

Post-patent, competition leads to price reductions:

• Initial pricing: Imatinib was priced at approximately USD 30,000 per patient per year in the U.S.
• Post-generic/biosimilar entry: Prices decline by up to 60%, with some biosimilars offering less than USD 10,000 annually.

Pricing Tier	Year	USD per Patient	Observations
Brand Name	2010	30,000	Dominant in early 2000s
Biosimilar	2020	8,000	Significant price erosion

Market share shifts from branded to biosimilar products are expected to reach around 80% in key markets within five years of biosimilar approval.

What Are the Financial Projections for Future Revenue?

Analysts project a decline in global sales:

Year	Estimated Global Revenue (USD billion)	Notes
2022	3.8	Current baseline
2025	2.9	Projected decline due to biosimilar competition
2030	1.8	Near-complete biosimilar market penetration

The steepest declines are anticipated in mature markets like North America and Europe, where biosimilar adoption is rapid.

Factors Affecting Future Revenue

• Patent expiration in key markets.
• Accelerated biosimilar approvals.
• Competitive pricing strategies from biosimilar manufacturers.
• Potential for new indications or formulations extending product lifecycle.

Are There Opportunities for Market Expansion or New Indications?

Yes. Several efforts focus on:

• New formulations: Long-acting or combination therapies aim to improve adherence.
• New indications: Research into imatinib’s efficacy in other cancers, including dermatofibrosarcoma protuberans and certain hematologic conditions.
• Global markets: Emerging markets with growing healthcare infrastructure present growth opportunities for biosimilars.

Summary of Market and Financial Outlook

In the next five to ten years, the imatinib market is expected to see:

• Revenue decrease driven by biosimilar competition.
• Price erosion of 60-80% in mature markets post-generic entry.
• Opportunities in biosimilar manufacturing, especially in low- and middle-income countries.
• Potential for innovative formulations and new indications to slow revenue decline.

Key Takeaways

• Imatinib mesylate revenues peaked around 2018 at USD 4.6 billion, then declined due to patent expiry and biosimilar competition.
• Biosimilar entries have significantly lowered prices and market share of the original drug.
• Revenue projections indicate continued downward trend, with estimates of USD 2.9 billion by 2025.
• Market growth is shifting toward biosimilar markets in emerging economies.
• Innovation in formulations and exploration of new therapeutic indications could mitigate revenue declines.

FAQs

1. When did patent protection for imatinib expire in major markets?
   U.S. patents expired in 2016; EU patents expired in 2017, enabling biosimilar entry around 2018.

2. What is the current demand for biosimilars of imatinib?
   Biosimilar market share in Europe and the U.S. exceeds 50%, trending toward 80% in subsequent years.

3. How has biosimilar entry affected the price of imatinib?
   Prices have fallen by approximately 60-80%, with biosimilars priced around USD 8,000 annually compared to the original USD 30,000.

4. Are there new therapeutic indications for imatinib?
   Ongoing research explores potential uses beyond CML and GIST, but none are yet approved for new indications.

5. What are the main growth areas for imatinib-related products?
   Biosimilar manufacturing, oral formulation innovations, and markets in developing countries.

---

References

[1] IQVIA. (2023). Global Oncology Market Reports.
[2] U.S. Food and Drug Administration. (2023). Imatinib Mesylate (Gleevec).
[3] European Medicines Agency. (2022). Biosimilar Medicines.