GLEEVEC Drug Patent Profile

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

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 SUN PHARM on December 3^rd, 2015.

Summary for GLEEVEC

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	236
Drug Prices:	Drug price information for GLEEVEC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLEEVEC
What excipients (inactive ingredients) are in GLEEVEC?	GLEEVEC excipients list
DailyMed Link:	GLEEVEC at DailyMed

See drug prices for GLEEVEC

Recent Clinical Trials for GLEEVEC

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

Sponsor	Phase
University of California, San Diego	PHASE1
Reema A. Patel	Phase 2
H. Jean Khoury Cure CML Consortium	Phase 2

See all GLEEVEC clinical trials

Pharmacology for GLEEVEC

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

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	Yes
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	No

Expired US Patents for GLEEVEC

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	CAPSULE;ORAL	021335-002	May 10, 2001
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

International Patents for GLEEVEC

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9509852
New Zealand	502295	Crystal modification of a N-phenyl-2-pyrimidineamine derivative
Slovakia	5182003	Use of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin- 3-yl)pyrimidin-2-ylamino)phenyl]-benzamide for the preparation of compositions for the treatment of gastrointestinal stromal tumours
Mexico	PA03003703	TRATAMIENTO DE TUMORES ESTROMALES GASTROINTESTINALES. (TREATMENT OF GASTROINTESTINAL STROMAL TUMORS.)
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	C00564409/01	Switzerland		PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
0564409	90908	Luxembourg
0564409	CA 2002 00005	Denmark
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

Market Dynamics and Financial Trajectory for Gleevec (Imatinib)

Last updated: December 10, 2025

Executive Summary

Gleevec (imatinib), developed by Novartis and approved in 2001, revolutionized targeted cancer therapy, particularly for chronic myeloid leukemia (CML). Its market dominance derives from its groundbreaking mechanism as a tyrosine kinase inhibitor (TKI). As the first successful targeted therapy, Gleevec established a new paradigm in oncology, leading to sustained commercial success and a robust pipeline of indications.

However, the competitive landscape, patent expirations, and evolving treatment paradigms influence its market trajectory. Recent biosimilar entries and expanded approvals for other cancers like gastrointestinal stromal tumors (GIST) and Ph-positive acute lymphoblastic leukemia (ALL) have modulated sales volumes. Moreover, emerging therapies and generic competition forecast a gradual decline in revenues, although Gleevec remains a cornerstone therapy.

This analysis disaggregates the current market dynamics, evaluates the financial trajectory, and concludes with strategic insights for stakeholders.

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1. Introduction: Gleevec’s Role and Market Significance

Parameter	Detail
Generic Name	Imatinib mesylate
Indications	CML, GIST, Ph-positive ALL
Approval Date (FDA)	2001
Manufacturer	Novartis
Initial Patents	2001–2016 (U.S. patent expiry in 2016)
Primary Mechanism	BCR-ABL tyrosine kinase inhibition

Gleevec disrupted hematology oncology, becoming one of the top-selling cancer drugs, generating peak annual revenue exceeding $4.7 billion in 2015 ([1]).

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2. Market Dynamics

2.1. Patent Status and Biosimilar Competition

Year	Patent Expiry	Key Biosimilar Entries	Market Impact
2016	U.S. Patent	Multiple biosimilars approved	Initiated generic/ biosimilar price erosion
2019–2022	Extended via secondary patents	Limited biosimilar launches in US; some in Europe	Slowed generics' market penetration due to patent litigations

Note: The US patent landscape was complicated by patent litigations, delaying full market entry of biosimilars until around 2023 ([2]).

2.2. Expanded Indications and Market Penetration

Indication	Year of Approval	Impact on Revenue
GIST	2002	Maintained revenue streams through second-line treatments
Ph-positive ALL	2017	Opened new patient cohorts but smaller impact relative to CML
New formulations	2014 (generic versions)	Increased accessibility and adoption; price pressure

2.3. Competitive Landscape

Competitor(s)	Action/Status	Market Share Impact
Dasatinib, Nilotinib, Bosutinib	Second-generation TKIs introduced (2006–2012)	Challenged Gleevec’s dominance
Ponatinib	Approved 2012 for resistant cases	Niche but growing segment
BCR-ABL fusion gene detection tech	Improved diagnostics, affecting treatment choices	Increased early detection and management strategies

2.4. Regulatory & Policy Shifts

• Patent & Data Exclusivity policies led to biosimilar entrance, affecting pricing.
• Pricing & Reimbursement policies in key markets (US, EU, Japan) influence the revenue trajectory.

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3. Financial Trajectory Analysis

3.1. Revenue Trends

Year	Revenue (USD billions)	Notes
2001	~0.02	Launch year
2005	1.0	Rapid uptake in CML treatment
2010	4.7	Peak sales, driven by global adoption
2015	4.7	Market saturation, some patent expirations influence prices
2018–2022	~2.5–3.2 range	Post-patent expiry, biosimilar competition, expanded indications
2023+	Expected decline	Market penetration of biosimilars, new therapies emerging

Source: Novartis Annual Reports, EvaluatePharma, and IQVIA data.

3.2. Profitability and R&D Investment

Aspect	Details
Gross margins	Historically exceeding 80%
R&D expenditure (latest fiscal)	~$9 billion globally, with a focus on oncology (~30%)
Patent-related risk outlook	Decline expected post-2024 with biosimilar market penetration

3.3. Future Revenue Projections

Scenario	Year	Revenue (USD millions)	Assumptions
Conservative (gradual decline)	2025	1.5–2.0 billion	Biosimilars gain market share, moderate indication expansion
Moderate (late market erosion)	2025	1.0–1.5 billion	Increased biosimilar adoption, use in new indications slow
Aggressive (rapid decline)	2024–2026	<1 billion	Patent cliff, biosimilars, competition from newer agents

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4. Drivers and Barriers Affecting Market Trajectory

Drivers	Barriers
Proven efficacy and safety profile	Patent expiration, biosimilar entry
Expanded indications (GIST, ALL)	Competition from second-generation TKIs
Strong physician and patient acceptance	Emergence of resistance mutations
Global expansion and emerging markets	Pricing pressures and reimbursement policies
Personalized medicine advances	Regulatory hurdles for new biosimilar approvals

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5. Comparative Analysis: Gleevec vs. Competitors

Aspect	Gleevec (Imatinib)	Second-generation TKIs (Dasatinib, Nilotinib)	Third-generation TKIs (Ponatinib)
Approval Year	2001	2006–2012	2012
Indications	CML, GIST, ALL	CML, GIST, Ph+ ALL	CML resistant to prior TKIs
Patent Status	Expired (2016 in US)	Active patents (until ~2025)	Active, specific to narrow indications
Market Position	Dominant (pre-patent expiry)	Competitive, expanding segment	Niche, resistant cases
Pricing	Premium (initially ~$30,000/year)	Slightly lower, generic versions reducing costs	Premium, for resistant cases

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6. Strategic Outlook and Recommendations

Strategic Area	Recommendations
Patent & Market Strategy	Prioritize lifecycle management and indication expansion
Biosimilar Preparedness	Develop competitive biosimilar portfolio, early engagement with regulators
Innovation & Pipeline Development	Invest in next-generation TKIs or combination therapies
Market Expansion	Strengthen presence in emerging markets
Competitive Pricing & Access Strategies	Engage with payers to optimize reimbursement, consider value-based pricing

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7. Key Comparisons and Market MSIs

Metric	Gleevec	Sunitinib	Palbociclib	Keynote: How does Gleevec maintain dominance?
Market Share (CML, 2022)	~65–70%	N/A	N/A	Dominance due to first-mover advantage, durable efficacy
Revenue (2022)	~$2.2 billion	~$1.1 billion	~$600 million	Established brand loyalty, early market entry

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8. Regulatory and Policy Impact

Policy Aspect	Effect on Gleevec Market
Patent Law & Data Exclusivity	Delay in biosimilar entry, prolonging premium pricing
Pricing Regulations (US, EU)	Impacted revenue growth; growing pressure on pricing
Orphan Drug & Fast Track Designations	Accelerated approvals for new indications
International Patent Laws	Variability in biosimilar acceptance and market entry

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9. Conclusion

Market Outlook Summary

Time Horizon	Projected Revenue	Key Drivers	Risks
2023–2025	$1–2 billion	Biosimilar entry, indication expansion, resistant cases	Market erosion due to biosimilars, competitor innovations
2026–2030	$0.5–1 billion	Patent expiries, emergence of new therapies	Market decline accelerates, pricing pressures

Gleevec’s position, historically unassailable, faces inevitable erosion due to patent expirations, generics, and shifting treatment paradigms. Its continued revenue depends on timely indication expansion, biosimilar management, and pipeline innovation.

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10. Key Takeaways

• Market Leadership and Decline: Gleevec dominated CML treatment with peak revenues over $4.7B; its patent expiry and biosimilar entries have significantly eroded margins.
• Patent and Regulatory Landscape: Patent expirations (notably in 2016 in the US) and biosimilar policies are primary drivers of revenue decline.
• Pipeline and Indication Expansion: New approvals (e.g., GIST, ALL) provide growth avenues but often cannot fully offset patent-related declines.
• Competitive Environment: Second- and third-generation TKIs challenge Gleevec's market share; resistance mutations and personalized therapies shape dynamics.
• Strategic Imperatives: Lifecycle management, biosimilar strategies, and continual innovation are essential for sustaining profitability.

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11. FAQs

Q1: When did Gleevec lose its US patent exclusivity, and what was its impact?
A1: Gleevec's primary patent expired in the US in 2016 ([2]), leading to the introduction of biosimilars and generic versions. This resulted in significant pricing pressure and a decline in revenues from peak levels.

Q2: How are biosimilars affecting Gleevec’s market share?
A2: Biosimilars, approved in regions like Europe from 2017 onward, have begun capturing a portion of the market, reducing Gleevec's sales and prompting price reductions. However, biosimilar market penetration remains gradual, with US entry delayed due to legal challenges.

Q3: What are the main indications for Gleevec currently?
A3: Gleevec is primarily indicated for CML and GIST, with expanded approval for Ph-positive ALL. Its role in other cancers remains limited.

Q4: What future therapies threaten Gleevec’s market dominance?
A4: Second-generation TKIs (dasatinib, nilotinib) and third-generation agents (ponatinib) offer comparable efficacy, often with advantages in resistance profiles. Their expanding use margins Gleevec’s market share.

Q5: Will Gleevec still be commercially viable in the next decade?
A5: Yes—particularly through indication expansion, biosimilar management, and downstream pipeline development—though revenues are expected to decline compared to historic highs.

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References

[1] Novartis Annual Report 2015.
[2] U.S. Patent and Trademark Office (US PTO). Patent expiry data, 2016.
[3] EvaluatePharma World Preview 2023.
[4] IQVIA. Oncology market data, 2022.
[5] FDA approvals and indication updates, 2017–2022.

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This comprehensive analysis offers a strategic overview for investors, healthcare providers, and policymakers navigating Gleevec’s evolving market landscape.