Dasatinib - Generic Drug Details

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

Dasatinib is the generic ingredient in three branded drugs marketed by Alembic, Apotex, Biocon Pharma, Dr Reddys, Eugia Pharma, Lupin, Teva Pharms Usa, Zydus Pharms, Handa Therap, and Bristol Myers Squibb, and is included in eleven NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dasatinib has fifty-six patent family members in twenty-nine countries.

There are fourteen drug master file entries for dasatinib. Fifteen suppliers are listed for this compound.

Summary for dasatinib

International Patents:	56
US Patents:	7
Tradenames:	3
Applicants:	10
NDAs:	11
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	379
Drug Prices:	Drug price trends for dasatinib
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dasatinib
What excipients (inactive ingredients) are in dasatinib?	dasatinib excipients list
DailyMed Link:	dasatinib at DailyMed

See drug prices for dasatinib

Recent Clinical Trials for dasatinib

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

Sponsor	Phase
M.D. Anderson Cancer Center	PHASE2
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1
Ohio State University	PHASE1

See all dasatinib clinical trials

Pharmacology for dasatinib

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

Medical Subject Heading (MeSH) Categories for dasatinib

Antineoplastic Agents

Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dasatinib

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

Paragraph IV (Patent) Challenges for DASATINIB

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 dasatinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	DASATINIB	dasatinib	TABLET;ORAL	218719-003	Mar 3, 2025	AB	RX	No	No
Dr Reddys	DASATINIB	dasatinib	TABLET;ORAL	213383-001	Mar 3, 2025	AB	RX	No	No
Biocon Pharma	DASATINIB	dasatinib	TABLET;ORAL	217217-001	Mar 3, 2025	AB	RX	No	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-006	Dec 5, 2023		RX	Yes	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-005	Dec 5, 2023		RX	Yes	Yes	12,544,376
Eugia Pharma	DASATINIB	dasatinib	TABLET;ORAL	216547-002	Apr 22, 2025	AB	RX	No	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006	AB	RX	Yes	No

Expired US Patents for dasatinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006	7,153,856*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	6,596,746*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006	8,680,103*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010	7,125,875*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	8,680,103*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006	6,596,746*PED
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	7,153,856*PED

International Patents for dasatinib

Country	Patent Number	Title	Estimated Expiration
Argentina	053984	COMBINACION DE UN INHIBIDOR DE PROTEINA CINASA SRC Y UN INHIBIDOR BCR - ABL PARA EL TRATAMIENTO DE ENFERMEDADES PROLIFERATIVAS
Canada	3168667	DISPERSIONS SOLIDES AMORPHES DE DASATINIB ET LEURS UTILISATIONS (AMORPHOUS SOLID DISPERSIONS OF DASATINIB AND USES THEREOF)
Mexico	2007005115	COMBINACION DE UN INHIBIDOR DE PROTEINA CINASA SRC Y UN INHIBIDOR DE PROTEINA CINASA BCR-ABL PARA EL TRATAMIENTO DE ENFERMEDADES PROLIFERATIVAS. (COMBINATION OF A SRC KINASE INHIBITOR AND A BCR-ABL INHIBITOR FOR THE TREATMENT OF PROLIFERATIVE DISEASES.)
European Patent Office	4714503
Japan	2007521340
Germany	602005018601
Australia	2005304863	Combination of a Src Kinase Inhibitor and a BCR-ABL inhibitor for the treatment of proliferative diseases

Supplementary Protection Certificates for dasatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	C300567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120
1169038	92146	Luxembourg		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1169038	6/2013	Austria		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	1390004-8	Sweden		PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
1169038	2013/003	Ireland		PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; 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
1169038	13C0003	France		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122

Market Dynamics and Financial Trajectory for DASATINIB

Last updated: October 28, 2025

Introduction

DASATINIB, marketed under brand names such as Sprycel, is a targeted tyrosine kinase inhibitor primarily approved for the treatment of chronic myeloid leukemia (CML) and specific cases of acute lymphoblastic leukemia (ALL) [1]. Since its approval by the U.S. Food and Drug Administration (FDA) in 2006, DASATINIB has become a significant player within the oncology therapeutics market. Understanding its market dynamics and financial trajectory is essential for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policymakers aiming to navigate the evolving landscape of targeted cancer therapies.

Market Landscape and Competitive Positioning

Current Market Size and Growth

The global CML therapeutics market was valued at approximately USD 4.5 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of around 8% through 2030 [2]. DASATINIB commands a significant share within this space, driven by its efficacy against resistant or intolerant cases of CML and newer indications.

Competitive Environment

While DASATINIB initially faced limited competition, the landscape has become increasingly crowded. Imatinib (Gleevec) remains the first-line standard-of-care; however, second-generation inhibitors like DASATINIB and nilotinib are pivotal for patients with resistance or intolerance [3]. More recently, third-generation TKIs, such as ponatinib, have added complexity. The competitive positioning of DASATINIB is maintained through its proven efficacy, safety profile, and established clinician confidence.

Patent and Regulatory Dynamics

DASATINIB's patent life, initially granted early in its lifecycle, is approaching expiration in several markets, which could challenge exclusivity and pricing power. Patent cliffs typically prompt generic or biosimilar entry, eroding revenue streams. Regulatory extensions, data exclusivity periods, and potential new indications may temporarily mitigate these effects.

Emerging Indications and Pipeline Development

Beyond CML and ALL, investigational use in other hematological malignancies and solid tumors could expand its market reach. The company’s pipeline efforts aim to position DASATINIB as a multi-indication agent, with potential to sustain revenues amid patent expirations.

Financial Trajectory Analysis

Revenue Trends

DASATINIB's global revenues peaked around USD 2.8 billion in 2019, with subsequent fluctuations influenced by patent expiry considerations, generic competition, and regional market dynamics [4]. In mature markets like the US and Europe, revenue growth remains stable due to brand loyalty and prescriber familiarity. However, in emerging markets, growth is bolstered by increasing diagnosis rates and improved healthcare infrastructure.

Pricing Strategy and Reimbursement

Pricing negotiations are pivotal, especially as biosimilars enter the market post-patent expiry. Reimbursement policies, especially in payor-driven environments like the US and EU, influence sales performance. Tiered pricing and patient assistance programs help sustain access and revenue.

Cost Structure and Profitability

DASATINIB benefits from high R&D costs amortized over its patent life, with substantial margins during exclusivity. Manufacturing costs are relatively low, given the established production processes for small-molecule TKIs. Post-expiry, profitability hinges on biosimilar pricing pressures.

Future Revenue Forecasts

Projections suggest a declining trajectory post-2025 due to patent expiries, unless expanded indications or combination therapies drive incremental revenues. Investment in pipeline development and market penetration strategies can offset some revenue erosion.

Impact of Biosimilars and Generics

The impending entry of biosimilars is expected to trigger significant price reductions, with estimates indicating a 20-40% decrease in US and European markets within two years of generic entry [5]. This will challenge the current revenue streams but may open opportunities in price-sensitive regions.

Market Drivers and Constraints

Drivers:

• Disease prevalence: Rising incidence of CML worldwide, notably in aging populations, fuels demand.
• Line of therapy: DASATINIB’s role as a second-generation TKI positions it favorably for resistant cases.
• Patient outcomes: Demonstrated efficacy and manageable safety profiles encourage prescriber adoption.
• Regulatory approvals: Expanding indications can stabilize or elevate market share.

Constraints:

• Patent expiration: Will lead to biosimilar competition and price erosion.
• Pricing pressures: Payor policies demanding cost-effective therapies.
• Market saturation: Clinician preference for established first-line treatments may limit uptake.
• Development risks: Pipeline attrition and regulatory hurdles for new indications.

Strategic Outlook

Pharmaceutical companies leveraging DASATINIB's portfolio focus on lifecycle management—through patent strategies, combination therapies, and geographic expansion—to sustain financial trajectories. Building alliances for biosimilar development and exploring novel indications can mitigate patent expiry impacts.

Conclusion

DASATINIB’s market and financial trajectory reflect a classic lifecycle progression for high-value targeted therapies. Steady revenue stems from its proven efficacy in hematological malignancies, but future sustainability relies heavily on patent protections, pipeline innovation, and market positioning strategies. Stakeholders must closely monitor patent timelines, regional healthcare policies, and emerging competitors to optimize financial outcomes.

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Key Takeaways

• DASATINIB remains a cornerstone in CML management, with a significant share in the targeted oncology market.
• Patent expiries threaten future revenue, emphasizing the need for pipeline innovation and lifecycle management.
• Biosimilar competition will drive pricing pressures, particularly from 2025 onward.
• Expanding therapeutic indications and geographic markets offer growth opportunities.
• Strategic collaborations and regional market entry are vital to offset impending patent declines.

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FAQs

1. When is DASATINIB's patent set to expire in major markets?
   Patent expiration varies by region, with key patents in the US and Europe expected to lapse between 2024 and 2026, opening the market to biosimilar competition [4].

2. What are the main competitors of DASATINIB in the CML treatment market?
   Imatinib (Gleevec), nilotinib (Tasigna), and ponatinib (Iclusig) are leading competitors, with the choice depends on disease resistance, side effect profiles, and patient-specific factors [3].

3. Are there ongoing clinical trials expanding DASATINIB's indications?
   Yes, several trials explore its use in solid tumors and other hematologic malignancies. However, regulatory approval for new indications remains pending or under review.

4. How does biosimilar entry impact DASATINIB’s profitability?
   Biosimilars typically reduce prices by 20-40%, significantly impacting revenue and margins post-approval, unless new value-adding indications are developed.

5. What strategies can sustain DASATINIB’s market relevance?
   Lifecycle extension via new indications, combination therapies, regional expansion, and development of biosimilars are key strategies for maintaining market share and profitability.

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References

[1] U.S. Food and Drug Administration (FDA). Sprycel (Dasatinib) Prescribing Information. 2006.

[2] Grand View Research. Leukemia therapeutics market size & trends. 2022.

[3] Baccarani M, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia. Blood, 2013.

[4] MarketWatch. DASATINIB sales analysis and patent status. 2022.

[5] IQVIA. Global biosimilar market forecast. 2022.