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Generated: October 18, 2018

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Dabigatran etexilate mesylate - Generic Drug Details

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What are the generic drug sources for dabigatran etexilate mesylate and what is the scope of dabigatran etexilate mesylate freedom to operate?

Dabigatran etexilate mesylate is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for dabigatran etexilate mesylate. Two suppliers are listed for this compound.

Medical Subject Heading (MeSH) Categories for dabigatran etexilate mesylate
Synonyms for dabigatran etexilate mesylate
(Z)-ethyl 3-(2-(((4-(N'-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate methanesulfonate
1-methyl-2-[N-[4-(N-n-hexyloxycarbonylamidino)phenyl]-amino-methyl]-benzimidazol-5-yl-carboxylic acid-N-(2-pyridyl)-N-(2-ethoxycarbonylethyl)-amide mesylate
593282-20-3
728P819
872728-81-9
AB1008443
AC-26434
AKOS015951091
AKOS015994531
beta-Alanine, N-((2-(((4-((((hexyloxy)carbonyl)amino)iminomethyl)phenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)-N-2-pyridinyl-, ethyl ester, methanesulfonate
BIBR 1048 MS
BIBR 1048MS
BIBR-1048
BIBR-1048-MS
BIBR-1048MS
BS-1008
C34H41N7O5.CH4O3S
CCG-213236
CHEBI:70743
CHEMBL1615369
CP0128
CS-1398
CS-W004358
D07082
Dabigatran etexilate (mesylate)
Dabigatran etexilate mesilate
Dabigatran etexilate mesylate (USAN)
Dabigatran etexilate mesylate [USAN]
Dabigatran etexilate mesylate; N-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-|A-alanine ethyl ester monomethanesulfonat
Dabigatran etexilate methanesulfonate
Dabigatran etexilate methanesulfonate (JAN)
DABIGATRAN ETEXILATE; METHANESULFONIC ACID
DTXSID20236248
ethyl (Z)-3-(2-(((4-(N'-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate methanesulfonate
Ethyl 3-(((2-(((4-(((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)(pyridin-2-yl)amino)propanoate, methanesulfonate
ethyl 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1h-benzimidazole-5-carbonyl)-pyridin-2-yl-amino]-propionate methanesulphonate
ethyl 3-[[2-[[4-(N-hexoxycarbonylcarbamimidoyl)anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid
ethyl N-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl]-N-pyridin-2-yl-beta-alaninate methanesulfonate
FT-0660872
HY-10274A
KB-76396
LP114850
MolPort-020-313-389
N-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-|A-alanine Ethyl Ester Methanesulfonate
Pradaxa
Pradaxa mesylate
Pradaxa, Dabigatran etexilate mesylate
Prazaxa
Rendix
SC7NUW5IIT
SCHEMBL1268805
UNII-SC7NUW5IIT
W-5683
X1061
XETBXHPXHHOLOE-UHFFFAOYSA-N

US Patents and Regulatory Information for dabigatran etexilate mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-001 Oct 19, 2010 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
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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International Patents for dabigatran etexilate mesylate

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2005028468 ➤ Try a Free Trial
Denmark 1870100 ➤ Try a Free Trial
Poland 335154 ➤ Try a Free Trial
Norway 326918 ➤ Try a Free Trial
Mexico 2012008360 ➤ Try a Free Trial
Serbia 52088 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for dabigatran etexilate mesylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0 Finland ➤ Try a Free Trial
19/2008 Austria ➤ Try a Free Trial PRODUCT NAME: DABIGATRANETEXILAT UND DESSEN SALZE, INSBESONDERE DABIGATRANETEXILAT-MESILAT
90025-4 Sweden ➤ Try a Free Trial PRODUCT NAME: DABIGATRANETEXILATMESILAT; REG. NO/DATE: EU/1/08/442/001-008 20080318
2017 00031 Denmark ➤ Try a Free Trial PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
2017 00031 Denmark ➤ Try a Free Trial PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
2012021 Lithuania ➤ Try a Free Trial PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/009 - EU/1/08/442/014 20110801
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Dow
Queensland Health
Chubb
Daiichi Sankyo
McKesson
AstraZeneca
Healthtrust
Moodys

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