GLEEVEC Drug Patent Profile

When do Gleevec patents expire, and what generic alternatives are available?

Gleevec is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in GLEEVEC is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gleevec

A generic version of GLEEVEC was approved as imatinib mesylate by TEVA PHARMS USA on August 4^th, 2016.

Summary for GLEEVEC

US Patents:	0
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLEEVEC

Paragraph IV (Patent) Challenges for GLEEVEC

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 GLEEVEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-001	May 10, 2001		DISCN	Yes	No
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003	AB	RX	Yes	No
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-002	May 10, 2001		DISCN	Yes	No
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003	AB	RX	Yes	Yes

International Patents for GLEEVEC

See the table below for patents covering GLEEVEC around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20030051656
Argentina	016351	FORMA CRISTALINA BETA DE LA SAL DE ADICIoN DE ÁCIDO METANSULFoNICO DE 4-(4-METILPIPERAZIN-1-ILMETIL)-N-[4-METIL-3-(4-PIRIDIN-3-IL) PIRIMIDIN-2-ILAMINO) FENIL] BENZAMIDA, COMPOSICIoN FARMACÉUTICA, USO DE LA FORMA CRISTALINA PARA LA PREPARACIoN DE UN AGENTE FARMACOLoGICO, Y PROCESOS PARA LA PREPARACIo
Poland	209733
Brazil	1100739

Supplementary Protection Certificates for GLEEVEC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0564409	SPC005/2002	Ireland		SPC005/2002: 20051123, EXPIRES: 20160620
0564409	C00564409/01	Switzerland		PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
0564409	90908	Luxembourg

Last updated: February 3, 2026

What Is GLEEVEC and Its Market Position?

Gleevec (imatinib) is a tyrosine kinase inhibitor developed by Novartis as a targeted therapy for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It was FDA-approved in 2001 and remains the first-line treatment for specific cancers. The drug's patent protection expired in 2016 in the U.S., with generic versions available since then.

Gleevec's market has faced significant erosion due to generics but continues to generate revenue through brand loyalty, manufacturing quality, and patent extensions in specific jurisdictions. It also maintains a presence in rare or resistant cases where generics are less utilized.

What Are the Key Financials and Patent Status?

Revenue Performance

• 2017: ~$4.9 billion worldwide (pre-generic)
• 2018–2020: Revenue declined sharply, reaching ~$3.5 billion in 2020
• 2021–2022: Revenue stabilized around ~$2.8 billion, indicating residual brand strength and improved access in some markets

Patent and Exclusivity Timeline

• Original patent protection in the U.S. expired in 2016
• Patent extensions and formulation patents in other countries delayed generic entry until recent years
• Multiple patent litigations contributed to delay of generics, with some courts upholding patent claims through 2021

Revenue from Generics

By 2022, generics primarily dominated CML treatment in the U.S., leading to a sharp decrease in Gleevec’s revenue. brand sales persist mainly in markets with patent protections or limited generic presence.

What Are the Competitive Dynamics?

Market Competition

The introduction of generic imatinib drastically reduced Gleevec's price and market share. Competitors like Pfizer’s Bosulif, Bristol-Myers Squibb’s Sprycel, and Takeda’s Tasigna target similar indications. However, Gleevec retains a niche in specific resistant cases, rare indications, or in regions with limited generics.

Pricing Trends

Generic prices for imatinib dropped by over 90% within two years of patent expiry, leading to significant revenue decline for the brand. New formulations or delivery methods have not yet offset this decline substantially.

How Do Regulatory and Legal Factors Affect Investment?

Patent litigation delayed generic entry until 2020–2022, with courts sometimes upholding patents on method-of-use claims or formulation patents. Future patent litigations may extend exclusivity in certain markets.

Regulatory pathways for biosimilars and entry of generics in high-income markets continue to pressure Gleevec sales. Price controls in some regions also limit revenue potential.

What Are the R&D and Pipeline Considerations?

While the original molecule’s patent has lapsed, Novartis has initiated research into next-generation tyrosine kinase inhibitors and combination therapies. These have limited impact on current Gleevec revenue but could preserve pipeline value.

Potential new indications for imatinib are being explored, including in dermatology and other cancers, but these are experimental and not yet commercially significant.

What Are Growth and Investment Risks?

• Patent expiries: Accelerate generic erosion.
• Pricing pressures: Particularly in Europe and emerging markets.
• Competitive landscape: New targeted therapies and biosimilars threaten the market share.
• Regulatory hurdles: Patent challenges and approval processes for generics and biosimilars.
• Pipeline dependency: Future revenues depend on successful development of next-generation drugs or new indications.

What Is the Fundamental Investment Outlook?

Gleevec’s revenue has declined sharply following patent expiry, with residual sales limited in competitive markets. Investment opportunities hinge on potential growth in rare or resistant disease populations, emerging indications, or strategic patent litigations. The main risk is the rapid commoditization due to generics and biosimilars.

Long-term valuation is limited unless Novartis demonstrates sustained competitive advantage via pipeline innovations or new formulations. The current investment case aligns with a high-risk, high-reward profile centered on territorial patent protections, legal strategies, and pipeline prospects.

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Key Takeaways

• Gleevec, once a blockbuster, faces diminished revenue due to patent expiry and generic competition.
• Patent litigation and regulatory strategies temporarily delayed generic penetration, but generics now dominate much of its market.
• Ongoing pipeline developments offer potential future growth avenues but have yet to deliver measurable financial impact.
• Market dynamics strongly favor generic suppliers, pressuring the brand's profitability.
• Investment considerations must factor in patent landscape, legal risk, and pipeline viability.

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FAQs

1. How long will Gleevec retain any exclusivity rights?
Patent protections in some jurisdictions could extend exclusivity until at least 2024, but primary patent expiry was in 2016. Future patent litigations may influence this timeline.

2. Are there ongoing patent litigations that could prolong Gleevec’s market dominance?
Yes. Novartis has engaged in multiple patent disputes which, if successful, could delay generic entry further in certain markets.

3. What are the primary competitors to Gleevec?
Competitors include Sprycel (dasatinib), Tasigna (nilotinib), and Bosulif (bosutinib). These target similar indications, especially in resistant or advanced cases.

4. How do regulatory pathways impact Gleevec’s future revenue?
Biosimilar and generic approvals in major markets are likely to erode Gleevec sales further, especially as regulatory standards for biosimilars evolve.

5. Is investment in Gleevec's successor drugs promising?
Next-generation therapies and combination approaches have limited commercial impact so far but could provide growth if clinical development succeeds.

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Sources

1. Novartis Annual Reports, 2017–2022.
2. U.S. Food and Drug Administration (FDA). Gleevec approval.
3. Market research reports on generic drug erosion (IQVIA, 2022).
4. Patent databases and legal case summaries.
5. Industry analyses on tyrosine kinase inhibitors and targeted cancer therapies.