You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 11, 2024

Dabigatran etexilate mesylate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Alkem Labs Ltd DABIGATRAN ETEXILATE MESYLATE dabigatran etexilate mesylate CAPSULE;ORAL 208040-002 Mar 11, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-003 Jun 21, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alembic DABIGATRAN ETEXILATE MESYLATE dabigatran etexilate mesylate CAPSULE;ORAL 215233-003 Aug 12, 2024 AB RX No 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
>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
Malaysia 145632 3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO]-PROPIONIC ACID ETHYLESTER-METHANESULFONATE AND ITS USE AS A MEDICAMENT ⤷  Sign Up
France 17C1026 ⤷  Sign Up
South Korea 101781787 ⤷  Sign Up
Peru 20121516 ANTIDOTOS DE ANTICOAGULANTES ⤷  Sign Up
Denmark 1660482 ⤷  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
0966454 C00966454/01 Switzerland ⤷  Sign Up PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
1870100 300538 Netherlands ⤷  Sign Up PRODUCT NAME: DABIGATRAN ETEXILAAT MESILAAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
2525812 C02525812/01 Switzerland ⤷  Sign Up PRODUCT NAME: IDARUCIZUMABUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65804 20.07.2016
0966454 PA2008008,C0966454 Lithuania ⤷  Sign Up PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
2525812 1790034-1 Sweden ⤷  Sign Up PRODUCT NAME: IDARUCIZUMAB GODKAENNANDE EU/1/15/1056
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.