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SPRYCEL Drug Profile

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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 five patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and twenty-four patent family members in thirty-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.

US ANDA Litigation and Generic Entry Outlook for Sprycel

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

There have been five 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.

Indicators of Generic Entry

Summary for SPRYCEL

International Patents:	124
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	116
Clinical Trials:	54
Patent Applications:	5,027
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SPRYCEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPRYCEL
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
National Cancer Institute (NCI)	Phase 1
Anne Noonan	Phase 1
Jorge J. Castillo, MD	Phase 1

See all SPRYCEL clinical trials

Recent Litigation for SPRYCEL

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Wyeth LLC v. Sun Pharmaceutical Industries, Inc.	2016-12-23
Pfizer Inc. v. Zydus Pharmaceuticals USA Inc.	2012-06-22
BRISTOL-MYERS SQUIBB COMPANY v. APOTEX, INC.	2010-11-08

See all SPRYCEL litigation

Pharmacology for SPRYCEL

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

Synonyms for SPRYCEL

1N1

2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)-N-(2-chloro-6-methylphenyl)thiazole-5-carboxamide

2-{6-[4-(2-Hydroxy-ethyl)-piperazin-1-yl]-2-methyl-pyrimidin-4-ylamino}-thiazole-5-carboxylic acid (2-chloro-6-methyl-phenyl)-amide

2359AH

302962-49-8

302962-49-8 pound not863127-77-9

49310-EP2270008A1

49310-EP2292617A1

49310-EP2311840A1

5-Thiazolecarboxamide, monohydrate

5-Thiazolecarboxamide, N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)-1-piperazinyl)-2-methyl-4-pyrimidinyl)amino)-

5-Thiazolecarboxamide, N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-

A-2429

AB0066750

AB01273956_03

AB01273956-01

AB01273956-02

AC-22749

AC1MI3ET

AC1Q2P0C

AKOS015902363

AM20080877

AN-5289

anh. dasatinib

anhydrous dasatinib

ANW-43935

AOB87355

API0002220

AX8035158

BCB03_000715

BCP01797

BCP9000589

BCPP000263

BDBM13216

BMS 345825

BMS 354825

BMS 354825; Sprycel

BMS 354825|||Sprycel

BMS 35482513

BMS Dasatinib

BMS-354825

BMS-354825-03

BMS-354825;BMS354825;BMS 354825

BMS354825

BR-47532

BRD-K49328571-001-05-1

BRD-K49328571-001-07-7

CAS-302962-49-8

CD0138

CHEBI:49375

CHEMBL1421

cid_3062316

CS-0100

CTK8B4120

D-3307

D03658

Dasatinib

Dasatinib - BMS-354825

dasatinib (anh.)

Dasatinib (anhydrous)

Dasatinib (BMS-354825)

Dasatinib (JAN/INN)

Dasatinib [USAN:INN]

Dasatinib [USAN]

Dasatinib anhydrous

Dasatinib BMS-354825

Dasatinib D8

Dasatinib, BMS 354825

Dasatinib,BMS-354825

Dasatinib;

dasatinibum

DB01254

DSSTox_CID_20979

DSSTox_GSID_40979

DSSTox_RID_79608

DTXSID4040979

EN002710

EX-A401

FC0026

FT-0084503

FT-0650671

GS-6548

GTPL5678

HMS2043N05

HMS3244A05

HMS3244A06

HMS3244B05

HMS3265C19

HMS3265C20

HMS3265D19

HMS3265D20

HMS3654K05

HY-10181

I14-1972

KB-274688

KB-76415

Kinome_3650

KS-0000027F

LS-186641

LS-187028

LS-187773

MLS003915609

MLS004774145

MLS006010904

MolPort-003-846-143

N-(2-chloro-6-methyl-phenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methyl-pyrimidin-4-yl]amino]thiazole-5-carboxamide

n-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)amino)-1,3-thiazole-5-carboxamide

N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)amino)thiazole-5-carboxamide

N-(2-CHLORO-6-METHYLPHENYL)-2-({6-[4-(2-HYDROXYETHYL)PIPERAZIN-1-YL]-2-METHYLPYRIMIDIN-4-YL}AMINO)-1,3-THIAZOLE-5-CARBOXAMIDE

N-(2-chloro-6-methylphenyl)-2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thia

N-(2-chloro-6-methylphenyl)-2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thiazole-5-carboxamide

N-(2-Chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl)]-2-methyl-4-pyrimidinyl]amino)]-1,3-thiazole-5-carboxamide

N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl]amino]-1,3-thiazole-5-carboxamide

NCGC00181129-01

NCGC00181129-02

NCGC00181129-03

NCGC00181129-05

NCGC00181129-06

NCGC00181129-12

NSC-732517

NSC-759877

NSC732517

NSC759877

OR302638

Pharmakon1600-01502275

Q-101345

QCR-106

RTR-013021

RTR-021205

s1021

SB17284

SC-22079

SCHEMBL8226

SMR002529551

Sprycel (Bristol Meyers)

SR-00000000554

SR-00000000554-5

ST2419212

SW208076-5

SYN1036

Tox21_112736

Tox21_112736_1

TR-013021

TRA0075817

UNII-X78UG0A0RN

X78UG0A0RN

Z2786158251

ZBNZXTGUTAYRHI-UHFFFAOYSA-N

ZINC3986735

Paragraph IV (Patent) Challenges for SPRYCEL

Tradename	Dosage	Ingredient	NDA	Submissiondate
SPRYCEL	TABLET;ORAL	dasatinib	021986	2011-06-17
SPRYCEL	TABLET;ORAL	dasatinib	021986	2010-06-28

US Patents and Regulatory Information for 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
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010		RX	Yes	No					Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006		RX	Yes	No
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010		RX	Yes	No

International Patents for SPRYCEL

Country	Patent Number	Estimated Expiration
Austria	453630
Australia	2005212405
Peru	10682004
Norway	322470

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	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	1390004-8	Sweden		PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
1169038	300567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120