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SPRYCEL Drug 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 five patents protecting this drug and three Paragraph IV challenges.

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.

Summary for SPRYCEL

US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	104
Clinical Trials:	47
Patent Applications:	5,634
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

Drug patent expirations by year for SPRYCEL

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

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Glossary

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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	➤ Sign Up	➤ Sign Up				➤ Sign Up
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-005	Oct 28, 2010		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	AB	RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Paragraph IV (Patent) Challenges for SPRYCEL

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Tablets	80 mg and 140 mg	➤ Subscribe	➤ Sign Up
➤ Subscribe	Tablets	80 mg and 140 mg	➤ Subscribe	➤ Sign Up
➤ Subscribe	Tablets	20 mg, 50 mg, 70 mg and 100 mg	➤ Subscribe	➤ Sign Up

International Patents for SPRYCEL

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Country	Document Number	Estimated Expiration
Russian Federation	2312860	➤ Sign Up
Russian Federation	2006131591	➤ Sign Up
Serbia	20050698	➤ Sign Up
Hong Kong	1091835	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for SPRYCEL

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
13/003	Ireland	➤ Sign Up	PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
2013 00006	Denmark	➤ Sign Up	PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
0567	Netherlands	➤ Sign Up	PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
00567	Netherlands	➤ Sign Up	PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Summary for SPRYCEL

Pharmacology for SPRYCEL

Medical Subject Heading (MeSH) Categories for SPRYCEL

Synonyms for SPRYCEL

Paragraph IV (Patent) Challenges for SPRYCEL

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