SPRYCEL Drug Patent Profile

When do Sprycel patents expire, and what generic alternatives are available?

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^® Generic Entry Outlook for Sprycel

Sprycel was eligible for patent challenges on June 28, 2010.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (dasatinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for SPRYCEL

International Patents:	47
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	176
Patent Applications:	3,095
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
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
Fernando De la Garza Salazar	Phase 2
Lew Lipsitz	Phase 1/Phase 2

See all SPRYCEL clinical trials

Pharmacology for SPRYCEL

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

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 four 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		RX	Yes	No					Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008		RX	Yes	Yes
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010		RX	Yes	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008		RX	Yes	Yes

Expired US Patents for SPRYCEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006

International Patents for SPRYCEL

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2005107463	ЦИКЛИЧЕСКИЕ ПРОТЕИНЫ ИНГИБИТОРОВ ТИРОЗИНКИНАЗЫ
Denmark	1610780
World Intellectual Property Organization (WIPO)	2006052810
Ukraine	87456	ЦИКЛІЧНІ ІНГІБІТОРИ ПРОТЕЇНТИРОЗИНКІНАЗ[ЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ПРОТЕИНТИРОЗИНКИНАЗЫ (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	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	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	92146	Luxembourg		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES