Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Johnson and Johnson
Merck
Accenture
Cerilliant
Argus Health
Healthtrust
Covington

Generated: August 19, 2018

DrugPatentWatch Database Preview

Dabigatran etexilate mesylate - Generic Drug Details

see a sample report or, see our see our flat-rate plans

« Back to Dashboard

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-five 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 ➤ 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 ➤ 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 022512-001 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 022512-003 Nov 20, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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 ➤ 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

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

see a sample report or, see our see our flat-rate plans

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 ➤ Try a Free Trial
6,414,008 Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions ➤ Try a Free Trial
6,469,039 Disubstituted bicyclic heterocycles, the preparation and the use thereof as pharmaceutical compositions ➤ Try a Free Trial
6,710,055 Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

see a sample report or, see our see our flat-rate plans

International Patents for dabigatran etexilate mesylate

Country Document Number Estimated Expiration
South Korea 20130041382 ➤ Try a Free Trial
Australia 2003210400 ➤ Try a Free Trial
New Zealand 545984 ➤ Try a Free Trial
Luxembourg 92025 ➤ Try a Free Trial
Norway 20042361 ➤ Try a Free Trial
Germany 10245624 ➤ Try a Free Trial
Spain 2614992 ➤ Try a Free Trial
Country Document Number Estimated Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Supplementary Protection Certificates for dabigatran etexilate mesylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00027 Denmark ➤ Try a Free Trial PRODUCT NAME: DABIGATRAN-ETEXILAT (SOM MESILAT); REG. NO/DATE: EU/1/08/442/001-002 20080318
2012000103 Germany ➤ Try a Free Trial PRODUCT NAME: DABIGATRANETEXILAT-MESYLAT; REGISTRATION NO/DATE: EU/1/08/442/009-014 20110801
0966454/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
2017021 Lithuania ➤ Try a Free Trial PRODUCT NAME: IDARUCIZUMABAS; REGISTRATION NO/DATE: EU/1/15/1056/001 20151120
90025-4 Sweden ➤ Try a Free Trial PRODUCT NAME: DABIGATRANETEXILATMESILAT; REG. NO/DATE: EU/1/08/442/001-008 20080318
117 Luxembourg ➤ Try a Free Trial
0120023 00122 Estonia ➤ Try a Free Trial PRODUCT NAME: DABIGATRAANETEKSILAAT (MESUELAADINA);REG NO/DATE: K(2008)1180 20.03.2008
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Mallinckrodt
McKinsey
Farmers Insurance
Colorcon
Boehringer Ingelheim
Fuji
UBS
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.