SPRYCEL Drug Patent Profile

When do Sprycel patents expire, 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. Sixteen 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	178
Patent Applications:	1,548
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
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
Fernando De la Garza Salazar	Phase 2
Odense Patient Data Explorative Network	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 one 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
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010	AB	RX	Yes	No

International Patents for SPRYCEL

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

Country	Patent Number	Title	Estimated Expiration
Argentina	044506	INHIBIDORES CICLICOS DE LA PROTEINA TIROSINA CINASA
Austria	464898
Australia	2004223828	Cyclic protein tyrosine kinase inhibitors
Australia	4233800	Cyclic protein tyrosine kinase inhibitors
Australia	779089

Supplementary Protection Certificates for SPRYCEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	13C0003	France		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
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	C01169038/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
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	92146	Luxembourg		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES

DrugChatter Q&A for SPRYCEL

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Sprycel loss of exclusivity?
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