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, 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-eight patent family members in fifty-two countries.

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

Summary for dabigatran etexilate mesylate

International Patents:	268
US Patents:	5
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	6
Patent Applications:	490
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
		110MG	CAPSULE;ORAL
		150MG	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	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		RX	Yes	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-005	Jun 21, 2021		RX	Yes	No					Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-002	Oct 19, 2010	AB	RX	Yes	Yes					Y
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	214358-002	Jun 21, 2021		RX	Yes	No

International Patents for dabigatran etexilate mesylate

Country	Patent Number	Title	Estimated Expiration
Ukraine	95601	МЕТАНСУЛЬФОНАТ ЭТИЛОВОГО ЭФИРА 3-[(2-{[4-(ГЕКСИЛОКСИКАРБОНИЛАМИНОИМИНОМЕТИЛ)ФЕНИЛАМИНО]МЕТИЛ}-1МЕТИЛ-1Н- БЕНЗИМИДАЗОЛ-5-КАРБОНИЛ)ПИРИДИН-2-ИЛАМИНО]ПРОПИОНОВОЙ КИСЛОТЫ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ ЕГО СОДЕРЖИТ;МЕТАНСУЛЬФОНАТ ЕТИЛОВОГО ЕФІРУ 3-[(2-{[4-(ГЕКСИЛОКСИКАРБОНІЛАМІНОІМІНОМЕТИЛ)ФЕНІЛАМІНО]МЕТИЛ}-1МЕТИЛ-1Н-БЕНЗИМІДАЗОЛ-5-КАРБОНІЛ)ПІРИДИН-2-ІЛАМІНО]ПРОПІОНОВОЇ КИСЛОТИ ТА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ЙОГО МІСТИТЬ (3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO]-PROPIONIC ACID ETHYL ESTER-METHANESULPHONATE AND PHARMACEUTICAL COMPOSITION COMPRISING THEREOF)
Germany	122008000020
Austria	430145
Taiwan	200512206	3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1h-benzimidazol-5-carbonyl)-pyridin-2-yl-amion]-propionic acid ethylester-methanesulfonate and its use as a medicament
Portugal	2525812

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
1485094	132012902112338	Italy		PRODUCT NAME: DABIGATRAN ETEXILATO MESILATO(PRADAXA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/442/009-011-012-013-014, 20110801
1485094	C20120023 00122	Estonia		PRODUCT NAME: DABIGATRAANETEKSILAAT (MESUELAADINA);REG NO/DATE: K(2008)1180 20.03.2008
2525812	32/2017	Austria		PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 (MITTEILUNG) 20151124
1870100	C01870100/01	Switzerland		PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012