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Dabigatran etexilate mesylate - Generic Drug Details
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-six drug master file entries for dabigatran etexilate mesylate. Three 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: | 26 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 34 |
| Clinical Trials: | 4 |
| 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 | 022512-003 | Nov 20, 2015 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| 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 | 022512-001 | Oct 19, 2010 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ 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 |
International Patents for dabigatran etexilate mesylate
Supplementary Protection Certificates for dabigatran etexilate mesylate
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 068 | Estonia | ➤ Sign Up | |
| 025 | Luxembourg | ➤ Sign Up | 92025, EXPIRES: 20230318 |
| 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 |
| 122 | Estonia | ➤ Sign Up | |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
