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Generated: April 20, 2019

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Dasatinib - Generic Drug Details

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What are the generic sources for dasatinib and what is the scope of dasatinib freedom to operate?

Dasatinib is the generic ingredient in two branded drugs marketed by Apotex Inc and Bristol Myers Squibb, and is included in two NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dasatinib has one hundred and twenty-one patent family members in thirty-nine countries.

There are fourteen drug master file entries for dasatinib. One supplier is listed for this compound.

Pharmacology for dasatinib
Medical Subject Heading (MeSH) Categories for dasatinib
Synonyms for dasatinib
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 - 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
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

US Patents and Regulatory Information for dasatinib

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 021986-001 Jun 28, 2006 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-003 Jun 28, 2006 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 RX Yes Yes ➤ 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

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Supplementary Protection Certificates for dasatinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1169038 6/2013 Austria ➤ Sign Up PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038 92146 Luxembourg ➤ Sign Up PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1169038 13C0003 France ➤ Sign Up PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
1169038 C01169038/01 Switzerland ➤ Sign Up FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Harvard Business School
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Mallinckrodt
Merck

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