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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 patent protection?
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.
Summary for dabigatran etexilate mesylate
| International Patents: | 256 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 23 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 33 |
| Clinical Trials: | 671 |
| Patent Applications: | 18 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dabigatran etexilate mesylate |
| DailyMed Link: | dabigatran etexilate mesylate at DailyMed |
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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International Patents for dabigatran etexilate mesylate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2060569 | ➤ Sign Up |
| Slovenia | 0966454 | ➤ Sign Up |
| Luxembourg | 92117 | ➤ Sign Up |
| Argentina | 073225 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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 |
