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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
Cerilliant
Mallinckrodt
UBS
US Department of Justice
Argus Health
Chubb
Covington

Generated: June 21, 2018

DrugPatentWatch Database Preview

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 patent protection?

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.

Dabigatran etexilate mesylate has two hundred and fifty-six patent family members in fifty-one countries.

There are twenty-three 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 022512-001 Oct 19, 2010 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ 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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Non-Orange Book US Patents for dabigatran etexilate mesylate

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
8,486,398 Anticoagulant antidotes comprising antibodies that bind dabigatran and/or related compounds ➤ Sign Up
6,414,008 Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions ➤ Sign Up
6,469,039 Disubstituted bicyclic heterocycles, the preparation and the use thereof as pharmaceutical compositions ➤ Sign Up
6,710,055 Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for dabigatran etexilate mesylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C020/2008 Ireland ➤ Sign Up SPC020/2008: 20090921, EXPIRES: 20230215
C0025 France ➤ Sign Up PRODUCT NAME: DABIGATRAN - ETEXILATE ET SES SELS EN PARTICULIER DABIGATRAN ETEXILATE MESILATE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/442/001 DU 20080318; REGISTRATION NO/DATE AT EEC: EU/1/08/442/001 DU 20080318
00560 Netherlands ➤ Sign Up PRODUCT NAME: DABIGATRAN-ETEXILAAT, DESGEWENST IN DE VORM VAN EEN ZOUT-IN HET BIJZONDER DABIGATRAN-ETEXILAAT-MESYLAAT; REGISTRATION NO/DATE: EU/1/08/442/009-014 20110801
2017 00031 Denmark ➤ Sign Up PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Citi
Daiichi Sankyo
Chinese Patent Office
UBS
Cipla
Colorcon
US Department of Justice
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.