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Last Updated: August 8, 2020

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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 Alkem Labs Ltd, Hetero Labs Ltd Iii, and Boehringer Ingelheim, and is included in three NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dabigatran etexilate mesylate has two hundred and sixty-six patent family members in fifty-two countries.

There are twenty-six drug master file entries for dabigatran etexilate mesylate. Three suppliers are listed for this compound. There are two tentative approvals for this compound.

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
  Start Trial  Start TrialEQ 150MG BASECAPSULE;ORAL
  Start Trial  Start TrialEQ 75MG BASECAPSULE;ORAL
  Start Trial  Start TrialEQ 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.

Medical Subject Heading (MeSH) Categories for dabigatran etexilate mesylate
Paragraph IV (Patent) Challenges for DABIGATRAN ETEXILATE MESYLATE
Tradename Dosage Ingredient NDA Submissiondate
PRADAXA CAPSULE;ORAL dabigatran etexilate mesylate 022512 2015-12-15
PRADAXA CAPSULE;ORAL dabigatran etexilate mesylate 022512 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 022512-003 Nov 20, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for dabigatran etexilate mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2525812 300882 Netherlands   Start Trial PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056/001 20151124
2525812 CA 2017 00031 Denmark   Start Trial PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
2525812 C20170024 00247 Estonia   Start Trial PRODUCT NAME: IDARUTSIZUMAB;REG NO/DATE: EU/1/15/1056 24.11.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Express Scripts
AstraZeneca
Dow
Mallinckrodt

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