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Last Updated: December 12, 2024

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
Recent Clinical Trials for dabigatran etexilate mesylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Daiichi Sankyo Co., Ltd.Early Phase 1
Mayo ClinicPhase 1
Huons Co.,Ltd.Phase 1

See all dabigatran etexilate mesylate clinical trials

Generic filers with tentative approvals for DABIGATRAN ETEXILATE MESYLATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up150MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign Up110MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign UpEQ 150MG BASECAPSULE;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 ClassDirect Thrombin Inhibitor
Mechanism of ActionThrombin 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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