SPRYCEL Drug Patent Profile

Which patents cover Sprycel, and when can generic versions of Sprycel launch?

Sprycel is a drug marketed by Bristol Myers Squibb and is included in one NDA. There is one patent 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. Fifteen 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:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPRYCEL

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 zero US patents and two 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	021986-001	Jun 28, 2006	AB	RX	Yes	No					Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010	AB	RX	Yes	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006	AB	RX	Yes	No					Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006	AB	RX	Yes	No					Y

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
Australia	2005304863	Combination of a Src Kinase Inhibitor and a BCR-ABL inhibitor for the treatment of proliferative diseases
Mexico	PA05010145	INHIBIDORES DE LA PROTEINA TIROSINA CINASA CICLICA. (CYCLIC PROTEIN TYROSINE KINASE INHIBITORS.)
Australia	2004223828	Cyclic protein tyrosine kinase inhibitors

Supplementary Protection Certificates for SPRYCEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	C01169038/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
1169038	2013/003	Ireland		PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
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	6/2013	Austria		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120

Investment Scenario and Fundamentals Analysis for SPRYCEL (Dasatinib)

Last updated: February 20, 2026

What is the current market and pipeline status for SPRYCEL?

Sprycel (dasatinib) is a tyrosine kinase inhibitor (TKI) primarily used for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Developed by Bristol-Myers Squibb (BMS), it was approved by the U.S. Food and Drug Administration (FDA) in 2006 for CML in chronic phase and accelerated phase.

Market Position

• Global sales in 2022: approximately $850 million.
• Leading indications include first-line treatment for CML, especially in patients resistant or intolerant to prior therapies.
• Competitive landscape: Includes drugs like imatinib, nilotinib, bosutinib, and newer agents such as asciminib.

Pipeline and Label Expansion

• Additional indications: Investigational use in pulmonary arterial hypertension (PAH), with Phase 2 trials ongoing.
• Potential expansion: Research into resistance mechanisms and combination therapies could open new markets.

What are the key drug fundamentals and financials?

Parameter	Details
Patent expiry	Protection until 2024-2025 in major markets
Manufacturing	BMS owns global manufacturing rights, no significant supply constraints reported
Pricing	Cost per month ranges from $10,000 to $15,000, depending on region and dosage
Market penetration	Established in USA, Europe, Japan, with emerging markets in Asia
R&D investments	Approx. $100 million annually, mostly for combination studies and resistance mechanisms

What are the competitive and regulatory risks?

• Patent cliff: Patent expiry around 2024-2025 could lead to generic erosion.
• Regulatory environment: Stringent approval processes for new indications or combination therapies.
• Market competition: Emergence of next-generation TKIs with better safety or efficacy profiles could diminish SPRYCEL market share.
• Resistance development: Resistance mutations such as T315I limit long-term effectiveness.

What is the regulatory outlook and manufacturing landscape?

• Regulatory approvals: Widely approved in key markets with ongoing supplemental filings for expanded indications.
• Manufacturing capacity: Sufficient to meet current demand; no supply chain issues reported.
• Compliance and safety: Post-marketing surveillance indicates a stable safety profile, with adverse events like myelosuppression and fluid retention being manageable.

What are the investment implications?

• Near-term: Strong sales driven by existing approvals; patent expiry approaching.
• Long-term: Potential for growth if new indications or combination therapies succeed; risk of generic competition after 2024.
• Strategic moves: BMS's pipeline activities aimed at resistance mutation targets (e.g., asciminib) could mitigate patent risks and sustain revenue.

Critical data points

• Annual sales (2022): $850 million.
• Patent expiry: 2024–2025.
• Key competitors: Imetinib, nilotinib, bosutinib, asciminib.
• Pipeline: Phase 2 trials for PAH; exploration of combination regimens for resistant CML.

Key considerations for investors

• Patents effective until 2024-2025, after which generics could erode sales.
• Continued market penetration in Asia may support revenue.
• Pipeline expansion into PAH and resistance mutation therapies offers growth pathways.
• Market competition and resistance mutations pose long-term risks.

Key Takeaways

• SPRYCEL remains a profitable asset for BMS but faces patent expiration risks.
• The drug holds a dominant position in CML with steady revenues.
• Pipeline developments could extend the lifecycle but remain uncertain.
• Competitive drugs and resistance development threaten future market share.
• Strategic options include pipeline focus and geographic expansion to offset patent expiry declines.

Frequently Asked Questions

1. When does SPRYCEL patent protection expire?
Protection is set to expire in major markets around 2024–2025, potentially opening the market to generics.

2. What are the primary competitors?
Imatinib, nilotinib, bosutinib, and asciminib are leading competitors, with asciminib showing promise as a novel mechanism.

3. What new indications are under development?
Research into pulmonary arterial hypertension and addressing resistance mutations in CML.

4. How vulnerable is the drug to generic competition?
Patents nearing expiration create significant risk of generic erosion in revenue.

5. What strategies may BMS adopt to sustain revenue?
Pipeline expansion, especially into resistant mutation therapies, and geographic growth in emerging markets.

References

[1] Bristol-Myers Squibb. (2022). Annual report.
[2] U.S. Food and Drug Administration. (2006). SPRYCEL approval letter.
[3] EvaluatePharma. (2023). Oncology market report.
[4] European Medicines Agency. (2019). SPRYCEL summary.
[5] ClinicalTrials.gov. (2023). Dasatinib pipeline trials.