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 are two patents 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. One supplier is 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 November 23^rd, 2021.

Summary for SPRYCEL

International Patents:	47
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	171
Patent Applications:	1,896
Formulation / Manufacturing:	see details
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
Astex Pharmaceuticals, Inc.	Phase 2
Butler University	Phase 1
National Institutes of Health (NIH)	Phase 2

See all SPRYCEL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SPRYCEL

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

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 two US patents and five FDA Regulatory Exclusivities.

Patents protecting SPRYCEL

FDA Regulatory Exclusivity protecting SPRYCEL

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	021986-006	Oct 28, 2010	AB	RX	Yes	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008		RX	Yes	Yes
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010	AB	RX	Yes	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008		RX	Yes	Yes
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008		RX	Yes	Yes					Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006		RX	Yes	No					Y

Expired US Patents for SPRYCEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010

International Patents for SPRYCEL

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

Country	Patent Number	Title	Estimated Expiration
China	1989969	Cyclic protein tyrosine kinase inhibitors
European Patent Office	1169038	INHIBITEURS CYCLIQUES DE PROTEINE TYROSINE KINASE (CYCLIC PROTEIN TYROSINE KINASE INHIBITORS)
Czech Republic	20013677	Cyklické inhibitory protein tyrosin kinasy (Cyclic inhibitors of protein tyrosine kinase)
New Zealand	542171	Cyclic protein tyrosine kinase inhibitors
Argentina	044506	INHIBIDORES CICLICOS DE LA PROTEINA TIROSINA CINASA
Japan	2002542193

Supplementary Protection Certificates for SPRYCEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	6/2013	Austria		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	92146	Luxembourg		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
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	2013C/005	Belgium		PRODUCT NAME: DASATINIB SOUS TOUTES FORMES COUVERTES PAR LA PROTECTION DU BREVET DE BASE INCLUANT LES SOLVATES, LES HYDRATES, TEL QUE LA FORME MONOHYDRATEE, ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/06/363/001 20061122
1169038	13C0003	France		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122