DrugPatentWatch Database Preview
Dabigatran etexilate mesylate - Generic Drug Details
What are the generic drug sources for dabigatran etexilate mesylate and what is the scope of freedom to operate?
Dabigatran etexilate mesylate
is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Hetero Labs Ltd Iii, and Boehringer Ingelheim, and is included in three NDAs. 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 sixty-six patent family members in fifty-two countries.
There are twenty-six drug master file entries for dabigatran etexilate mesylate. Three suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for dabigatran etexilate mesylate
| International Patents: | 266 |
| US Patents: | 5 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 5 |
| Patent Applications: | 88 |
| 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 |
Recent Clinical Trials for dabigatran etexilate mesylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mayo Clinic | Phase 1 |
| Huons Co.,Ltd. | Phase 1 |
| Janssen Research & Development, LLC | Phase 1 |
Generic filers with tentative approvals for DABIGATRAN ETEXILATE MESYLATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 150MG BASE | CAPSULE;ORAL |
| Start Trial | Start Trial | EQ 75MG BASE | CAPSULE;ORAL |
| Start Trial | Start Trial | EQ 150MG BASE | CAPSULE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Medical Subject Heading (MeSH) Categories for dabigatran etexilate mesylate
Paragraph IV (Patent) Challenges for DABIGATRAN ETEXILATE MESYLATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PRADAXA | CAPSULE;ORAL | dabigatran etexilate mesylate | 022512 | 2015-12-15 |
| PRADAXA | CAPSULE;ORAL | dabigatran etexilate mesylate | 022512 | 2014-10-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208040-002 | Mar 11, 2020 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-001 | Oct 19, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-002 | Oct 19, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-002 | Oct 19, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-002 | Oct 19, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2011178803 | Start Trial |
| Croatia | P20170613 | Start Trial |
| Austria | 239712 | Start Trial |
| Brazil | 0306559 | Start Trial |
| Japan | 2005519099 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for dabigatran etexilate mesylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0966454 | 91437 | Luxembourg | Start Trial | 91437, EXPIRES: 20230216 |
| 1870100 | 300538 | Netherlands | Start Trial | PRODUCT NAME: DABIGATRAN ETEXILAAT MESILAAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318 |
| 2525812 | LUC00028 | Luxembourg | Start Trial | PRODUCT NAME: PRAXBIND - IDARUCIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1056 20151124 |
| 2525812 | PA2017021,C2525812 | Lithuania | Start Trial | PRODUCT NAME: IDARUCIZUMABAS; REGISTRATION NO/DATE: EU/1/15/1056/001 20151120 |
| 0966454 | PA2008008,C0966454 | Lithuania | Start Trial | PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
