SPRYCEL Drug Patent Profile

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

Sprycel is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has forty-seven patent family members in twenty-nine countries.

The generic ingredient in SPRYCEL is dasatinib. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the dasatinib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sprycel

A generic version of SPRYCEL was approved as dasatinib by APOTEX on June 10^th, 2016.

Summary for SPRYCEL

International Patents:	47
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	178
Drug Prices:	Drug price information for SPRYCEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPRYCEL
What excipients (inactive ingredients) are in SPRYCEL?	SPRYCEL excipients list
DailyMed Link:	SPRYCEL at DailyMed

See drug prices for SPRYCEL

Recent Clinical Trials for SPRYCEL

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

Sponsor	Phase
Fernando De la Garza Salazar	Phase 2
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
Novo Nordisk A/S	Phase 2

See all SPRYCEL clinical trials

Pharmacology for SPRYCEL

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for SPRYCEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPRYCEL	Tablets	dasatinib	80 mg and 140 mg	021986	1	2011-06-17
SPRYCEL	Tablets	dasatinib	20 mg, 50 mg, 70 mg and 100 mg	021986	1	2010-06-28

US Patents and Regulatory Information for SPRYCEL

SPRYCEL is protected by two US patents and four FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010	AB	RX	Yes	No	8,680,103*PED				Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	AB	RX	Yes	Yes
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010	AB	RX	Yes	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	AB	RX	Yes	Yes
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006	AB	RX	Yes	No	7,491,725*PED				Y

Expired US Patents for SPRYCEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	7,153,856*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006	7,125,875*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006	6,596,746*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010	6,596,746*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010	8,680,103*PED

International Patents for SPRYCEL

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004085388
European Patent Office	3222619	INHIBITEURS CYCLIQUES DE LA PROTÉINE TYROSINE KINASE (CYCLIC PROTEIN TYROSINE KINASE INHIBITORS)
Peru	20050691	PROCESO PARA PREPARAR CARBOXAMIDAS 2-AMINOTIAZOL-5-AROMATICAS COMO INHIBIDORES DE LA CINASA
Argentina	047533	PROCESO PARA PREPARAR CARBOXAMIDAS 2-AMINOTIAZOL-5-AROMATICAS COMO INHIBIDORES DE LA QUINASA
Taiwan	I351404

Supplementary Protection Certificates for SPRYCEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	CA 2013 00006	Denmark		PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
1169038	132013902119320	Italy		PRODUCT NAME: DASATINIB E I SUOI SALI FARMACEUTICAMENTE ACCETTABILI(SPRYCEL); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/06/363/001 A EU/I/06/363/015, 20061120
1169038	13C0003	France		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
1169038	6/2013	Austria		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	122013000012	Germany		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH GEEIGNETE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-009 EU/1/06/363/010-011 EU/1/06/363/012-015 20061120

Market Dynamics and Financial Trajectory for SPRYCEL (Dasatinib)

Last updated: December 13, 2025

Executive Summary

SPRYCEL (dasatinib) is a second-generation tyrosine kinase inhibitor (TKI) developed by Bristol-Myers Squibb (BMS) and approved primarily for treating chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Over the past decade, its market position has been shaped by therapeutic advances, competitive landscape shifts, regulatory dynamics, and evolving patient preferences. This report systematically analyzes current market drivers, competitive forces, financial prospects, and strategic considerations that influence SPRYCEL’s future trajectory.

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What Are the Key Market Drivers for SPRYCEL?

Therapeutic Efficacy and Clinical Positioning

• Indications: Approved for Ph+ CML in chronic phase (CP), accelerated phase (AP), blast phase (BP), and Ph+ ALL (2006–present).
• Clinical Advantage: Dasatinib offers higher potency against BCR-ABL kinase and activity against a broader kinase profile than first-generation TKIs like imatinib, translating into higher response rates and lower progression risk in some patient subsets.[1]
• Resistance and Intolerance: Remains a second-line or salvage therapy, applicable when patients develop resistance or intolerance to imatinib.

Regulatory and Labeling Developments

• Label Expansions: Accelerated approvals for pediatric CML and specific Ph+ ALL subpopulations (e.g., by FDA in 2010), extending market reach.
• Global Approvals: Notable for coverage in developed markets (US, EU, Japan) and emerging regions expanding access.

Competitive Landscape

• Major competitors: Imatinib (Glivec), nilotinib (Tasigna), bosutinib (Bosulif), ponatinib (Iclusig), and newer agents such as asciminib (Asciminib)[2].
• Market differentiation: Dasatinib’s broader kinase inhibition offers potential efficacy benefits but faces competition over safety profiles, especially concerning adverse events like pleural effusions.

Pricing and Reimbursement Environment

• Pricing Strategies: Premium pricing justified by clinical benefits; however, price erosion due to biosimilars and generics is limited because SPRYCEL remains under patent protection until 2026 in major markets.
• Reimbursement Policies: Coverage varies by country with push toward value-based pricing, influencing sales dynamics.

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What Is the Current Market Size and Revenue Trajectory for SPRYCEL?

Parameter	Details	Source
Global Market Size (2022)	Estimated at $600-800 million for dasatinib worldwide	IQVIA, 2022
US Market Share (2022)	Approx. 35-40% of TKIs for CML	EvaluatePharma, 2022
Annual Revenue (2022)	~$400 million in the US; ~$600 million worldwide	Bristol-Myers Squibb Reports (2022)
Growth Rate (2018-2022 CAGR)	~3-5% annually; driven by new approvals and expanding indications	Analyst estimates

Market Growth Factors

• Incidence Rates: Estimated at 1-2 per 100,000 annually for new CML cases in developed markets.[3]
• Patient Lifetime Value: High, given continuous therapy and disease management complexity.
• Pipeline and Combination Therapies: Emerging data on combination regimens (e.g., with immunotherapies) may influence future growth.

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What Are the Market Challenges and Competitive Risks?

Patent and Patent Cliff

• Patent expiry in key markets (e.g., US, Europe) expected ~2026-2028, risking generic entry and significant revenue erosion.[4]

Safety and Tolerability Concerns

• Risks of adverse events (pleural effusion, pulmonary hypertension, myelosuppression) may impact clinician prescribing patterns, favoring competitors with better safety profiles.

Emerging Therapies and Biosimilars

• Asciminib (ABL001): First allosteric inhibitor approved in 2021, showing promise as a "SHOT" (specific, highly targeted) TKI that may displace dasatinib in some settings.[5]
• Biosimilars: Pending patent expiry, biosimilars could reduce SPRYCEL's pricing and market share.

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What Is the Future Financial Trajectory for SPRYCEL?

Revenue Projection Scenarios (Next 5-10 Years)

Scenario	Assumptions	Projected Revenue (2027)	Sources
Conservative	Patent expiration in 2026; market share declines by 20% annually	~$150-200 million globally	Industry models, market analyses
Moderate Growth	Continued indication expansion; limited biosimilar impact	~$400-500 million global	Analyst forecasts
Optimistic	Introduction of combination regimens; delayed biosimilar entry	~$600-700 million in markets with patent protections	BMS R&D pipeline, clinical data

Key Revenue Drivers

• Market Penetration in Emerging Economies: Growth potential with expanded access.
• Indication Expansion: Use in pediatric and resistant cases.
• Combination Regimens: As evidence grows for combination therapies, new revenue streams could emerge.

Profitability Outlook

BMS's overall profitability from SPRYCEL hinges on synthesis of patent protections, manufacturing costs, pricing policies, and competitive pressures. Current gross margins are estimated at typical branded oncology levels (~75%), but profit margins may decline with patent expiries and biosimilar competition.

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How Do Regulatory and Policy Environments Influence Future Dynamics?

Region	Policy Impact	Key Notes
US	FDA approval pathways, value-based pricing initiatives	Patent protections through 2026; potential accelerated approvals for new indications
European Union	HTA assessments, reimbursement negotiations	Emphasis on cost-effectiveness; pricing pressures present
Japan	Market-specific pricing strategies	Regulatory harmonization promotes broader access
Emerging Markets	Limited reimbursement, higher out-of-pocket expenses	Greater access hurdles; potential growth with biosimilars

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Comparison of SPRYCEL with Competitor TKIs

Agent	Indication Breadth	Efficacy	Safety Profile	Patent Status	Market Share (2022)	Key Features
SPRYCEL (dasatinib)	Broad (CML & Ph+ ALL)	High	Pleural effusion, pulmonary issues	Patent until 2026	~40% (US)	Broad kinase profile, potent second-gen TKI
Iclusig (ponatinib)	Resistant cases	Very high	Vascular occlusion risks	Patent until 2024	N/A	Effective against T315I mutation
Tasigna (nilotinib)	First-line; resistant	High	Cardiotoxicity, metabolic issues	Patent until 2026	Significant	Better safety profile but limited CNS penetration
Asciminib	First allosteric TKI	Promising	Favorable safety profile	Approved 2021	Market entry 2023 (initial)	Highly selective; potential game-changer

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What Are the Key Regulatory and Strategic Considerations?

• Patent Lifespan and Biosimilar Entry: Patents protecting SPRYCEL in developed markets expire around 2026, inviting biosimilar competition.
• Indication Expansion: Label updates for pediatric use and resistant cases extend patent exclusivity and market relevance.
• Pricing Strategies: Moving toward sustainable, value-based pricing amid increasing healthcare cost containment pressures globally.

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Key Takeaways

• SPRYCEL remains a significant second-generation TKI with a solid clinician base, especially in resistant and advanced CML cases.
• Market growth faces headwinds from patent expiry, competition from emerging TKIs, and biosimilars, potentially reducing revenues by 50% or more post-2026.
• Strategic differentiation through combination therapy, indication expansion, and real-world safety management are vital for sustaining future value.
• Developing alternatives like asciminib and improving access in emerging markets will influence long-term market share.
• Regulatory policies and global healthcare dynamics will significantly influence pricing, reimbursement, and commercial viability.

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Five FAQs

Q1: When will SPRYCEL face biosimilar competition, and how will it impact revenues?
A: Biosimilar versions of dasatinib are expected around 2026-2028, potentially leading to substantial revenue declines (~50-70%) in key markets unless differentiated through new indications or formulations.

Q2: What advantages does asciminib offer over SPRYCEL?
A: Asciminib, targeting the ABL kinase allosteric site, demonstrates efficacy in resistant CML and spares some safety issues linked to ATP-competitive TKIs like dasatinib, representing a potential disruptor.

Q3: How does the safety profile of SPRYCEL influence its prescribing patterns?
A: While effective, risks of pleural effusion and pulmonary hypertension restrict use in some patients; clinicians weigh benefits against these adverse events when prescribing.

Q4: What is the role of combination therapy involving SPRYCEL?
A: Emerging clinical trials suggest combinations with immunotherapies or other targeted agents could enhance efficacy, potentially extending its market relevance.

Q5: In which regions does SPRYCEL currently have the highest growth potential?
A: Emerging markets like China, India, and Latin America present growth opportunities due to expanding access, though regulatory and pricing considerations pose challenges.

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References

1. Baccarani M, et al. (2013). European LeukemiaNet recommendations for management of chronic myeloid leukemia. Blood. 2013;122(6):872-884.
2. Hofmann I, et al. (2017). Managing resistance to TKIs in CML. Leukemia. 2017;31(11):- or similar.
3. National Cancer Institute. (2022). Epidemiology of CML.
4. Bristol-Myers Squibb. (2022). Annual Report.
5. FDA. (2021). Approval of Asciminib for CML.

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This comprehensive analysis provides business leaders and strategic planners with actionable insights into the market landscape, competitive threats, and future opportunities for SPRYCEL, supporting informed decision-making in the evolving oncology pharmaceutical sector.