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 freedom to operate?
Dabigatran etexilate mesylate
is the generic ingredient in two branded drugs marketed by Alembic, Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, MSN, and Boehringer Ingelheim, and is included in seven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Dabigatran etexilate mesylate has one hundred and twenty patent family members in forty-four countries.
There are twenty-four drug master file entries for dabigatran etexilate mesylate. Thirteen suppliers are listed for this compound. There are six tentative approvals for this compound.
Summary for dabigatran etexilate mesylate
International Patents: | 120 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 7 |
Drug Master File Entries: | 24 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 69 |
Clinical Trials: | 6 |
Patent Applications: | 264 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dabigatran etexilate mesylate |
What excipients (inactive ingredients) are in dabigatran etexilate mesylate? | dabigatran etexilate mesylate excipients list |
DailyMed Link: | dabigatran etexilate mesylate at DailyMed |
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 |
Generic filers with tentative approvals for DABIGATRAN ETEXILATE MESYLATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 150MG | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 110MG | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-001 | Oct 19, 2010 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | PELLETS;ORAL | 214358-005 | Jun 21, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | PELLETS;ORAL | 214358-006 | Jun 21, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | PELLETS;ORAL | 214358-001 | Jun 21, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | |||
>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 | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1109299 | ⤷ Sign Up | |
Norway | 20061420 | ⤷ Sign Up | |
Singapore | 182552 | ANTICOAGULANT ANTIDOTES | ⤷ Sign Up |
Taiwan | 201202217 | 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amion]-propionic acid ethylester-methanesulfonate and its use as a medicament | ⤷ Sign Up |
Japan | 5348842 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dabigatran etexilate mesylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1870100 | CA 2012 00027 | Denmark | ⤷ Sign Up | PRODUCT NAME: DABIGATRAN-ETEXILAT (SOM MESILAT); REG. NO/DATE: EU/1/08/442/001-002 20080318 |
2525812 | 1790034-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: IDARUCIZUMAB GODKAENNANDE EU/1/15/1056 |
2525812 | 300882 | Netherlands | ⤷ Sign Up | PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056/001 20151124 |
2525812 | 283 14-2017 | Slovakia | ⤷ Sign Up | PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 20151124 |
2525812 | 2017034 | Norway | ⤷ Sign Up | PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: 20151124 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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