DABIGATRAN ETEXILATE MESYLATE Drug Patent Profile
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When do Dabigatran Etexilate Mesylate patents expire, and what generic alternatives are available?
Dabigatran Etexilate Mesylate is a drug marketed by Alembic, Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and MSN. and is included in five NDAs.
The generic ingredient in DABIGATRAN ETEXILATE MESYLATE is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dabigatran Etexilate Mesylate
A generic version of DABIGATRAN ETEXILATE MESYLATE was approved as dabigatran etexilate mesylate by ALKEM LABS LTD on March 11th, 2020.
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Questions you can ask:
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Summary for DABIGATRAN ETEXILATE MESYLATE
Recent Clinical Trials for DABIGATRAN ETEXILATE MESYLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Daiichi Sankyo Co., Ltd. | Early Phase 1 |
| Mayo Clinic | Phase 1 |
| Huons Co.,Ltd. | Phase 1 |
Pharmacology for DABIGATRAN ETEXILATE MESYLATE
| Drug Class | Direct Thrombin Inhibitor |
| Mechanism of Action | Thrombin Inhibitors |
Medical Subject Heading (MeSH) Categories for DABIGATRAN ETEXILATE MESYLATE
Anatomical Therapeutic Chemical (ATC) Classes for DABIGATRAN ETEXILATE MESYLATE
Paragraph IV (Patent) Challenges for DABIGATRAN ETEXILATE MESYLATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PRADAXA | Capsules | dabigatran etexilate mesylate | eq. to 110 mg base | 022512 | 2 | 2015-12-15 |
| PRADAXA | Capsules | dabigatran etexilate mesylate | eq. to 75 mg base and 150 mg base | 022512 | 17 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 215233-001 | Jun 14, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208070-001 | Dec 15, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208040-001 | Mar 11, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd Iii | DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 207961-002 | May 6, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208070-002 | Dec 15, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
