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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 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

International Patents:	267
US Patents:	5
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	6
Patent Applications:	88
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

Sponsor	Phase
Daiichi Sankyo Co., Ltd.	Early Phase 1
Mayo Clinic	Phase 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
		EQ 150MG BASE	CAPSULE;ORAL
		EQ 75MG BASE	CAPSULE;ORAL
		EQ 150MG BASE	CAPSULE;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 Class	Direct Thrombin Inhibitor
Mechanism of Action	Thrombin Inhibitors

Medical Subject Heading (MeSH) Categories for dabigatran etexilate mesylate

Antithrombins

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					Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-005	Jun 21, 2021		RX	Yes	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-003	Jun 21, 2021		RX	Yes	No

International Patents for dabigatran etexilate mesylate

Country	Patent Number	Estimated Expiration
Portugal	1485094
Denmark	2060569
Czech Republic	297768

Supplementary Protection Certificates for dabigatran etexilate mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2525812	CA 2017 00031	Denmark		PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
2525812	627	Finland
2525812	C201730027	Spain		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