dasatinib - Profile

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.

Summary for dasatinib

International Patents:	56
US Patents:	7
Tradenames:	3
Applicants:	10
NDAs:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dasatinib

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
Alembic	DASATINIB	dasatinib	TABLET;ORAL	216261-001	Nov 6, 2025	AB	RX	No	No
Alembic	DASATINIB	dasatinib	TABLET;ORAL	216261-002	Nov 6, 2025	AB	RX	No	No
Alembic	DASATINIB	dasatinib	TABLET;ORAL	216261-003	Nov 6, 2025	AB	RX	No	No
Alembic	DASATINIB	dasatinib	TABLET;ORAL	216261-004	Nov 6, 2025	AB	RX	No	No

International Patents for dasatinib

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0515721	uso de um inibidor de src cinase e um inibidor de bcr-abl, composição farmacêutica e combinação
Canada	2555291	PROCEDE DE PREPARATION DE CARBOXAMIDES 2-AMINOTHIAZOLE-5-AROMATIQUES UTILES COMME INHIBITEURS DE KINASES (PROCESS FOR PREPARING 2-AMINOTHIAZOLE-5-AROMATIC CARBOXAMIDES AS KINASE INHIBITORS)
Australia	2005304863	Combination of a Src Kinase Inhibitor and a BCR-ABL inhibitor for the treatment of proliferative diseases
Norway	20072179

Supplementary Protection Certificates for dasatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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

Investment Scenario and Fundamentals Analysis for Dasatinib

Last updated: February 19, 2026

Summary:
Dasatinib, marketed as Sprycel, is a kinase inhibitor approved for certain leukemias. It is a key product with patent exclusivity in major markets, but faces generic competition as patents expire. The compound's market depends on the pipeline, pricing strategies, and regulatory environment. Investors must weigh current sales, patent landscapes, competitive dynamics, and upcoming clinical developments.

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Market Overview and Competitive Landscape

Dasatinib is approved for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The global CML drug market was valued at approximately USD 3.2 billion in 2022 and is projected to grow modestly.

Major competitors include:

• Imatinib (Gleevec)
• Bosutinib (Bosulif)
• Nilotinib (Tasigna)
• Ponatinib (Iclusig)

Dasatinib's market share relies on its potency, safety profile, and resistance patterns. In 2022, dasatinib had approximately USD 1.2 billion in sales globally.

Competitor	Approximate Market Share (2022)	Key Features
Dasatinib	40%	Broad activity, efficacy in resistant cases
Imatinib	30%	First-generation, legacy product
Nilotinib	15%	Twice daily dosing, some resistance issues
Bosutinib	10%	Favorable side effect profile
Ponatinib	5%	Active on T315I mutation, third-line treatment

Patent expiry timelines critically impact the competitive dynamics. The primary dasatinib patent in the US expired in 2023, opening market space for generics.

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Patent and Regulatory Considerations

• Patent Status: The key composition of matter patent for dasatinib expired in the US in 2023. Other jurisdictions, such as Europe and Japan, have extended patent protections until 2024–2026 via supplementary patents and data exclusivity.
• Market Entry: Several generic manufacturers have launched dasatinib generics in the US post-2023; initial impact seen in 2023–2024 sales decline.
• Regulatory Environment: The FDA grants 180-day exclusivity for first generic entrants, encouraging rapid competition. Regulatory delays in other markets can prolong brand dominance.

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Sales and Revenue Dynamics

Sales are sensitive to patent cliffs, pricing, and uptake of generics:

Year	Dasatinib Sales (USD millions)	Comments
2020	1,300	Stable, patent protection active
2022	1,200	Post-patent expiry in US; decline begins
2023	900	Generic competition increases
2024+	Decline estimated to 50-70% initially	Market stabilizes based on generics

Additional revenue streams include:

• Expanded indications (e.g., new leukemia subtypes)
• Combination therapy trials
• Development of next-generation kinase inhibitors

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Pipeline and Clinical Development

The future value depends on ongoing research:

• SUNITRANS: Ongoing Phase 3 trial for resistance and intolerance cases.
• New Formulations: Once-daily formulations aim to improve adherence.
• Combination Regimens: Trials combining dasatinib with immunotherapies, targeting resistant cases.

If these projects lead to regulatory approval, revenue potential may rebound even amidst generic competition.

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Investment Risks and Opportunities

Risks:

• Patent expiration: Leads to revenue erosion once generics enter the market.
• Generic competition: Price erosion and market share loss.
• Clinical trial results: Negative or delayed results may reduce future prospects.
• Regulatory barriers: Delays or denials impact pipeline success.

Opportunities:

• Pipeline success: Next-generation inhibitors or new indications could create premium pricing.
• Market penetration: Growth in emerging markets with fewer patent protections.
• Combination therapies: Expanded use cases to boost sales.
• Acquisition or partnership: Leverage licensing for pipeline expansion.

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Valuation Considerations

Investors should consider:

• Sales trajectory post-patent expiry.
• Patent protection extensions in key markets.
• Earnings contribution from pipeline candidates.
• Competitive landscape shifts.
• Cost structure and margins, especially pertaining to generic price erosion.

Presently, dasatinib's valuation is conservative, factoring in patent expirations and generic entrant risks. Long-term value hinges on pipeline success and geographic expansion.

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Key Takeaways

• Dasatinib faces imminent patent expiry in key markets, risking significant revenue decline.
• The drug maintains current sales through market share and pricing strategies but must innovate or expand indications to sustain value.
• Generics in the US post-2023 have introduced pricing pressure; other markets follow suit in the coming years.
• Pipeline development offers potential upside but remains uncertain pending trial outcomes.
• Strategic partnerships, new formulations, and combination therapies can mitigate patent cliff risks.

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FAQs

Q1: When does dasatinib lose patent protection in major markets?
A1: US patent protection expired in 2023; Europe and Japan extend until 2024–2026 through supplementary patents.

Q2: How does generic entry affect dasatinib sales?
A2: Generic competition typically causes a rapid decline in sales volume and price, often eroding 50–70% of revenue within two years of entry.

Q3: What pipeline developments could bolster dasatinib’s future revenue?
A3: Trials for resistant leukemia subtypes, new formulations, and combination therapies hold promise for sustaining or growing sales.

Q4: How does market share compare among CML drugs?
A4: Dasatinib holds about 40% of the global market; imatinib leads with ~30%, and others follow, depending on resistance profiles and approval status.

Q5: What are the principal risks for investors in dasatinib?
A5: Patent expiry, aggressive generic competition, regulatory setbacks, and disappointing clinical trial results.

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References

1. MarketWatch. (2022). Global Chronic Myeloid Leukemia Drugs Market Analysis.
2. US Patent and Trademark Office. (2023). Patent expiration listings for dasatinib.
3. Evaluate Pharma. (2022). Oncology drug market insights.
4. Food and Drug Administration. (2023). List of approved leukemia therapies.
5. ClinicalTrials.gov. (2023). Dasatinib efficacy and safety studies.

Note: Data are estimates based on publicly available reports as of Q1 2023.