Dasatinib - Generic Drug Details

What are the generic sources for dasatinib and what is the scope of patent protection?

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	218719-002	Mar 3, 2025	AB	RX	No	No
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-005	Dec 5, 2023		RX	Yes	Yes	11,298,356		Y
Handa Therap	PHYRAGO	dasatinib	TABLET;ORAL	216099-006	Dec 5, 2023		RX	Yes	No

International Patents for dasatinib

Country	Patent Number	Title	Estimated Expiration
Japan	5148115
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.)
Australia	2021210974

Supplementary Protection Certificates for dasatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	1390004-8	Sweden		PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
1169038	13C0003	France		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
1169038	2013/003	Ireland		PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120

Dasatinib: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

Dasatinib is a second-generation BCR-ABL tyrosine kinase inhibitor (TKI) with sustained commercial scale driven by chronic myeloid leukemia (CML) and select Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). Financial trajectory has been shaped by (1) patent-expiry-led erosion of originator revenues, (2) entry and uptake of authorized generics and then lower-cost generics in key markets, and (3) lifecycle expansion through differentiated label segments (notably later-line CML/Ph+ ALL usage and combination strategies in practice).

What is the commercial and label footprint that underpins dasatinib revenue?

Core indications driving addressable market

• CML (BCR-ABL1 positive): chronic phase (CP), accelerated phase (AP), and blast phase (BP), including after resistance or intolerance to prior therapy
• Ph+ ALL: in patients with resistance or intolerance to prior therapy

Originator product and launch context

• Brand: Sprycel (Bristol Myers Squibb)
• Mechanism: BCR-ABL kinase inhibition (also active in Src-family kinases), supporting breadth across CML disease states

Why label sequencing matters Dasatinib’s commercial pattern tracks a typical TKI arc: initial peak during on-patent share capture, followed by generics and price compression. Uptake remains comparatively resilient when a product retains clinicians’ preference for particular prior-treatment settings, when dosing pathways reduce switching friction, and when payer formularies tolerate continued use due to safety and efficacy familiarity.

How have patent and generic timelines shaped market dynamics?

Market structure shift Dasatinib transitioned from originator-led revenues to a generic-dominant market. This structurally reduces:

• Net price per treated patient
• Total revenue for the originator and other higher-priced distributors
• Margin headroom across the supply chain

Observed pricing dynamic in small-molecule oncology In branded-to-generic transitions, the market typically moves through:

1. Authorized generic / launch of generics (fast price drop in many tender and reimbursement systems)
2. Wholesale distribution rationalization
3. Further price erosion as multiple low-cost suppliers compete

For dasatinib, this pattern is consistent with its long commercialization history and the fact that it is no longer a recent blockbuster launch. The effect is most visible in unit revenue and originator net revenue, not in treated patient volumes, which often remain more stable.

What are the key demand drivers and how do they influence utilization?

Clinical and practice drivers

• Line-of-therapy positioning: dasatinib is used across multiple treatment lines in CML/Ph+ ALL; earlier-line access is influenced by guideline adoption and competitor availability.
• Safety and tolerability profile: TKI selection balances efficacy with risks such as pleural effusion and other class effects, shaping switching behavior.
• Monitoring and adherence: chronic therapy duration supports steady demand when patients remain on therapy without discontinuation.
• Resistance patterns: certain mutation profiles can preserve dasatinib usage depending on prior exposure and available alternatives.

Payer and reimbursement drivers

• Formulary tiering: generics improve access but force budget-driven selection, often favoring the lowest cost within the class.
• Therapeutic substitution: many health systems treat TKIs as substitutable at the payer level even when clinical nuance exists, raising the impact of price competition.
• Patient assistance and contracting: originator and large generic players can maintain share through contracting, but contracts erode as margins compress and tenders reset.

How does dasatinib’s financial trajectory typically look post-loss of exclusivity?

Trajectory archetype for long-cycle TKIs After exclusivity, revenue often becomes dominated by:

• Volume-based sales by generic manufacturers
• Reduced average selling price (ASP)
• Lower promotional intensity
• Greater dependence on procurement cycles and tender wins

For the originator (Sprycel), this usually produces:

• Downward revenue slope as generic erosion accelerates
• Relative stability only in geographies where payer contracting and substitution controls slow the speed of erosion

Investor-relevant consequence Even with declining net revenue, treated-patient volume can remain material. That disconnect is key for assessing:

• Commercial cash generation (lower net sales, reduced margins)
• Future pipeline value (capital allocation shifts)
• Acquisition and distribution strategies among generic and specialty players

What market factors can accelerate or slow revenue erosion?

Accelerators

• Number of generic entrants: more suppliers intensify price competition and reduce originator share
• Tender cadence: frequent procurement resets push ASP down faster
• Stricter step therapy: payers limit branded use when generics are on-formulary
• Substitution policies: automatic substitution reduces prescriber control

Stabilizers

• Residual brand loyalty and prescriber preference in certain patient subgroups
• Managed care contracting that preserves specific suppliers at higher net prices
• Supply reliability and manufacturing capacity among preferred manufacturers
• Regional reimbursement differences in eligibility and switching rules

Competitive landscape: how does pricing pressure translate into share outcomes?

Dasatinib’s competitive set includes other BCR-ABL TKIs with overlapping indications, and the competitive intensity increases as:

• Generics lower the cost of older TKIs
• Newer agents capture guideline share in specific risk and resistance contexts
• Payers shift toward cost-minimizing choices within the class

In a generic-price environment, share outcomes depend less on differentiation and more on:

• Lowest net price
• Reliability of supply
• Contract terms (tender and pharmacy benefit manager positioning)
• Ability to service multiple formulations and dosing schedules

What does the patent-to-generic shift imply for financial modeling?

Model inputs that drive outcomes

• ASP/Net price erosion rate post entry
• Share migration from originator to authorized generics to multi-source generics
• Geographic mix (some markets adopt faster)
• Lifecycle utilization stability (discontinuation and switching assumptions)
• Contract timing (tender windows and PBM formulary updates)

Base-case financial effect

• Net revenue declines are usually faster than patient-volume declines.
• Operating margins for generic suppliers can remain stable or improve if scale offsets price erosion, while the originator experiences margin compression.

Strategic implication for R&D and investment The dasatinib case supports a broader commercial lesson for oncology TKIs:

• Clinical utility drives initial adoption, but financial durability after exclusivity depends on procurement mechanics and cost leadership.

What are the investment and business implications for stakeholders today?

For originators and specialty brands

• Revenue becomes a function of contracted channel position, not clinical uniqueness
• Remaining market value shifts toward lifecycle management, defense strategy, and pipeline read-through

For generic and biosimilar-adjacent manufacturers

• Dasatinib is a volume and execution story
• Competitive advantage comes from manufacturing efficiency, market access, and tender execution

For formulary decision-makers and payers

• Total cost of care improves when substitution occurs with no major clinical detriment at the population level
• Price transparency and contracting speed increasingly determine utilization

Key Takeaways

• Dasatinib is a mature oncology TKI with demand anchored in CML and select Ph+ ALL treatment settings.
• Market dynamics follow a branded-to-generic erosion curve typical for long-commercialized small molecules, with net price compression driving originator revenue decline.
• Financial trajectory is shaped by patent expiry timing, generic entry velocity, and tender or formulary substitution policies.
• Competitive outcomes now depend more on supply and net contracting terms than on differentiation.
• For modeling, the critical drivers are post-entry ASP erosion, share migration by geography, and tender timing rather than peak-demand clinical assumptions.

FAQs

1. What are dasatinib’s main commercial indications?
   CML (BCR-ABL1 positive) across chronic, accelerated, and blast phases, plus Ph+ ALL after resistance or intolerance to prior therapy.

2. Why does dasatinib revenue decline faster than patient volume after generics enter?
   Because generic entry primarily forces net price down through ASP and contract renegotiations, while treated patients can remain stable for some period.

3. What typically determines whether an older TKI keeps formulary share after exclusivity?
   Tender outcomes, payer step policies, substitution rules, and the ability of specific suppliers to win and retain net price contracts.

4. How does competition affect dasatinib’s financial trajectory?
   In early lines, newer TKIs can take share; in a generic environment, pricing and contracting dominate, pushing older TKIs toward cost-minimizing procurement.

5. What is the most important input for forecasting dasatinib sales post-launch of generics?
   Net price erosion rate tied to authorized generic and multi-source entry, plus contract and tender cadence that drives share migration.

References

[1] Bristol Myers Squibb. Sprycel (dasatinib) Prescribing Information.
[2] European Medicines Agency (EMA). Sprycel: EPAR summary and product information.
[3] U.S. Food and Drug Administration (FDA). Drug Approval Packages and label history for Sprycel (dasatinib).