DrugPatentWatch Database Preview➤ Get the DrugPatentWatch Daily Briefing
« Back to Dashboard
Dabigatran etexilate mesylateis the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Hetero Labs Ltd Iii, and Boehringer Ingelheim, and is included in four 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-seven 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 six tentative approvals for this compound.
Summary for dabigatran etexilate mesylate
|Drug Master File Entries:||26|
|Finished Product Suppliers / Packagers:||3|
|Raw Ingredient (Bulk) Api Vendors:||75|
|Formulation / Manufacturing:||see details|
|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
|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
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
|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||⤷ Free Forever Trial||⤷ Free Forever Trial||Y||⤷ Free Forever Trial|
|Boehringer Ingelheim||PRADAXA||dabigatran etexilate mesylate||PELLETS;ORAL||214358-005||Jun 21, 2021||RX||Yes||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Boehringer Ingelheim||PRADAXA||dabigatran etexilate mesylate||PELLETS;ORAL||214358-003||Jun 21, 2021||RX||Yes||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|2525812||CA 2017 00031||Denmark||⤷ Free Forever Trial||PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124|
|2525812||627||Finland||⤷ Free Forever Trial|
|2525812||C201730027||Spain||⤷ Free Forever Trial||PRODUCT NAME: IDARUCIZUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1056/001; DATE OF AUTHORISATION: 20151120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1056; DATE OF FIRST AUTHORISATION IN EEA: 20151120|
|>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:
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.