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 Alkem Labs Ltd, Apotex, and Hetero Labs Ltd Iii. and is included in three NDAs.
The generic ingredient in DABIGATRAN ETEXILATE MESYLATE is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Nine 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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Summary for DABIGATRAN ETEXILATE MESYLATE
![DABIGATRAN ETEXILATE MESYLATE drug patent expirations Drug patent expirations by year for DABIGATRAN ETEXILATE MESYLATE](/p/graph/s/t/DABIGATRAN_ETEXILATE_MESYLATE-patent-expirations.png)
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 |