➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Baxter
Mallinckrodt
McKesson
Johnson and Johnson

Last Updated: July 12, 2020

DrugPatentWatch Database Preview

Dabigatran etexilate mesylate - Generic Drug Details

» See Plans and Pricing

« 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 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
Mayo ClinicPhase 1
Huons Co.,Ltd.Phase 1
Janssen Research & Development, LLCPhase 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
Alkem Labs Ltd DABIGATRAN ETEXILATE MESYLATE dabigatran etexilate mesylate CAPSULE;ORAL 208040-002 Mar 11, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-001 Oct 19, 2010 AB RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 AB RX Yes Yes   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
>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
0966454 91437 Luxembourg   Start Trial 91437, EXPIRES: 20230216
1870100 300538 Netherlands   Start Trial PRODUCT NAME: DABIGATRAN ETEXILAAT MESILAAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
2525812 LUC00028 Luxembourg   Start Trial PRODUCT NAME: PRAXBIND - IDARUCIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1056 20151124
2525812 PA2017021,C2525812 Lithuania   Start Trial PRODUCT NAME: IDARUCIZUMABAS; REGISTRATION NO/DATE: EU/1/15/1056/001 20151120
0966454 PA2008008,C0966454 Lithuania   Start Trial PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Baxter
Mallinckrodt
McKesson
Johnson and Johnson

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.