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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 nineteen patent family members in thirty-nine countries.

The generic ingredient in SPRYCEL is dasatinib. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dasatinib profile page.

Summary for SPRYCEL

International Patents:	119
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	105
Clinical Trials:	47
Patent Applications:	4,545
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPRYCEL
DailyMed Link:	SPRYCEL at DailyMed

Pharmacology for SPRYCEL

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

Medical Subject Heading (MeSH) Categories for SPRYCEL

Antineoplastic Agents

Protein Kinase Inhibitors

Synonyms for SPRYCEL

(18F)-N-(2-chloro-6-methylphenyl)-2-(6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-ylamino)thiazole-5-carboxamide

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

AK-47532

AKOS015902363

AM20080877

AmbotzLS-1203

AN-5289

anh. dasatinib

anhydrous dasatinib

ANW-43935

AOB87355

API0002220

AX8035158

BCB03_000715

BCP9000589

BCPP000263

BDBM13216

BMS 345825

BMS 354825

BMS 354825|||Sprycel

BMS 35482513

BMS Dasatinib

BMS-354825

BMS-354825-03

BMS-354825, Sprycel, BMS354825, Dasatinib

BMS-354825;BMS354825;BMS 354825

BMS354825

BR-47532

BRD-K49328571-001-07-7

CAS-302962-49-8

CD0138

CHEBI:49375

CHEMBL1421

cid_3062316

CS-0100

CTK8B4120

D-3307

D03658

D0E6XR

Dasatinib

Dasatinib - BMS-354825

dasatinib (anh.)

Dasatinib (anhydrous)

Dasatinib (BMS-354825)

Dasatinib (INN)

Dasatinib (USAN)

Dasatinib [USAN:INN]

Dasatinib [USAN]

Dasatinib anhydrous

Dasatinib BMS-354825

Dasatinib, BMS 354825

Dasatinib,BMS-354825

Dasatinib;

dasatinibum

DB01254

DR003007

DSSTox_CID_20979

DSSTox_GSID_40979

DSSTox_RID_79608

DTXSID4040979

EN002710

EX-A401

FC0026

FT-0084503

FT-0650671

GS-6548

GTPL5678

HE333223

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

MFCD11046566

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)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate

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

NSC-732517

NSC-759877

NSC732517

NSC759877

Pharmakon1600-01502275

Q-101345

QCR-106

RTR-013021

RTR-021205

s1021

SC-22079

SCHEMBL8226

SMR002529551

Sprycel (Bristol Meyers)

SPRYCEL (TN)

Spyrcel

SR-00000000554

SR-00000000554-5

ST2419212

SYN1036

Tox21_112736

Tox21_112736_1

TR-013021

TRA0075817

UNII-X78UG0A0RN

X78UG0A0RN

Z2786158251

ZBNZXTGUTAYRHI-UHFFFAOYSA-N

ZINC3986735

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

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Paragraph IV (Patent) Challenges for SPRYCEL

Drugname	Dosage	Strength	RLD	Date
	Tablets	80 mg and 140 mg
	Tablets	80 mg and 140 mg
	Tablets	20 mg, 50 mg, 70 mg and 100 mg

Non-Orange Book US Patents for SPRYCEL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,993,567	Cyclic protein tyrosine kinase inhibitors
9,382,219	Cyclic protein tyrosine kinase inhibitors
8,242,270	Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
6,979,694	Cyclic protein tyrosine kinase inhibitors

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International Patents for SPRYCEL

Country	Document Number	Estimated Expiration
Germany	602004026703
Mexico	PA01010292
Spain	2391550
Australia	2005212405

Supplementary Protection Certificates for SPRYCEL

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038/01	Switzerland		FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
00567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120
2013 00006	Denmark		PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
0567	Netherlands		PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120