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. Nine 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:	9
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	PELLETS;ORAL	214358-004	Jun 21, 2021		RX	Yes	No					Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-003	Jun 21, 2021		RX	Yes	No					Y
Apotex	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208070-001	Dec 15, 2023	AB	RX	No	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-003	Nov 20, 2015	AB	RX	Yes	No					Y
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	214358-006	Jun 21, 2021		RX	Yes	Yes					Y

International Patents for dabigatran etexilate mesylate

Country	Patent Number	Title	Estimated Expiration
Ecuador	SP12012105	Antídotos de Anticoagulantes
Norway	20061420
Austria	430145
European Patent Office	2525812	ANTIDOTES D'ANTICOAGULANTS (ANTICOAGULANT ANTIDOTES)
South Africa	200704195	Film container
Eurasian Patent Organization	200600381	МЕТАНСУЛЬФОНАТ ЭТИЛОВОГО ЭФИРА 3-[(2-{[4-(ГЕКСИЛОКСИКАРБОНИЛАМИНОИМИНОМЕТИЛ)ФЕНИЛАМИНО]МЕТИЛ}-1-МЕТИЛ-1Н-БЕНЗИМИДАЗОЛ-5-КАРБОНИЛ)ПИРИДИН-2-ИЛАМИНО]ПРОПИОНОВОЙ КИСЛОТЫ И ЕГО ПРИМЕНЕНИЕ В КАЧЕСТВЕ ЛЕКАРСТВЕННОГО СРЕДСТВА

Supplementary Protection Certificates for dabigatran etexilate mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2525812	C20170024 00247	Estonia		PRODUCT NAME: IDARUTSIZUMAB;REG NO/DATE: EU/1/15/1056 24.11.2015
2525812	C201730027	Spain		PRODUCT NAME: IDARUCIZUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1056; DATE OF AUTHORISATION: 20151120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1056; DATE OF FIRST AUTHORISATION IN EEA: 20151120
0966454	08C0025	France		PRODUCT NAME: DABIGATRAN - ETEXILATE ET SES SELS EN PARTICULIER DABIGATRAN ETEXILATE MESILATE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/442/001 DU 20080318; REGISTRATION NO/DATE AT EEC: EU/1/08/442/001 DU 20080318
1485094	CA 2012 00054	Denmark		PRODUCT NAME: DABIGATRAN-ETEXILAT OG SALTENE DERAF; SAERLIGT DABIGATRAN-ETEXILAT-MESYLAT; REG. NO/DATE: EU/1/08/442/009-014 20080318
1870100	122012000047	Germany		PRODUCT NAME: DABIGATRAN ETEXILAT MESILAT = 3-((2-((4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO)-METHYL)-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO)-PROPIONSAEURE-ETHYLESTER-METHANSULFONAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
1870100	132012902065811	Italy		PRODUCT NAME: DABIGATRAN ETEXILATO MESILATO(PRADAXA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/442/001-2-3-4-5-6-7-8, 20080318