Dabigatran etexilate mesylate - Generic Drug Details

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, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim, and is included in five NDAs. There are three 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 forty-two patent family members in forty-four countries.

There are twenty-four drug master file entries for dabigatran etexilate mesylate. Eight suppliers are listed for this compound. There are ten tentative approvals for this compound.

Summary for dabigatran etexilate mesylate

International Patents:	142
US Patents:	3
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	6
Patent Applications:	303
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
		150MG	CAPSULE;ORAL
		110MG	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

Anatomical Therapeutic Chemical (ATC) Classes for dabigatran etexilate mesylate

B01AE	Direct thrombin inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-003	Nov 20, 2015	AB	RX	Yes	No					Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-005	Jun 21, 2021		RX	Yes	No					Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-001	Jun 21, 2021		RX	Yes	No
Hetero Labs Ltd Iii	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	207961-002	May 6, 2020	AB	RX	No	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-002	Oct 19, 2010	AB	RX	Yes	Yes
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-002	Jun 21, 2021		RX	Yes	No					Y

International Patents for dabigatran etexilate mesylate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1838595	EMBALLAGE EN FEUILLES (FILM CONTAINER)
Netherlands	300882
Spain	2326654
Lithuania	C2525812
European Patent Office	2060569	Hemihydrate de méthanesulfonate d'éthylester d'acide 3-[(2-{[4-hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionique et son utilisation comme médicament (Ethyl 3-[(2-{[4-Hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionate methanesulfonate hemihydrate and its use as a medicament)
Norway	338848

Supplementary Protection Certificates for dabigatran etexilate mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2525812	CR 2017 00031	Denmark		PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
2525812	2017034	Norway		PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: 20151124
1870100	C01870100/01	Switzerland		PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
2525812	300882	Netherlands		PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056/001 20151124
1870100	CA 2012 00027	Denmark		PRODUCT NAME: DABIGATRAN-ETEXILAT (SOM MESILAT); REG. NO/DATE: EU/1/08/442/001-002 20080318
2525812	LUC00028	Luxembourg		PRODUCT NAME: PRAXBIND - IDARUCIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1056 20151124