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, 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:	263
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
⤷ Sign Up	⤷ Sign Up	110MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	150MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208040-002	Mar 11, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-005	Jun 21, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-004	Jun 21, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-001	Oct 19, 2010	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-002	Oct 19, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Hetero Labs Ltd Iii	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	207961-002	May 6, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for dabigatran etexilate mesylate

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	009736	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 (3-[(2-{[4-HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDINE-2-YL-AMINO]-PROPIONIC ACID ETHYL ESTER METHANE SULPHONATE AND USE THEREOF AS A MEDICAMENT)	⤷ Sign Up
Australia	2005318231	Film container	⤷ Sign Up
Poland	2525812		⤷ Sign Up
Hong Kong	1173957	抗凝血劑抗體 (ANTICOAGULANT ANTIDOTES)	⤷ Sign Up
Montenegro	00340	ETIL 3-[(2-{[4-(HEKSILOKSIKARBONILAMINO-IMINO-METIL)-FENILAMINO]-METIL}-l-METIL-IH-BENZIMIDAZOL-5-KARBONIL)-PIRIDIN-2-IL-AMINO]-PROPIONAT-METANSULFONAT I NJEGOVA PRIMJENA KAO LIJEKA (3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL}-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDINE-2-YL-AMINO]-PROPIONIC ACID ETHYL ESTER METHANE SULPHONATE AND USE THEREOF AS A MEDICAMENT)	⤷ Sign Up
Australia	2004274139	3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridine-2-yl-amino]-propionic acid ethyl ester methane sulphonate and use thereof as a medicament	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for dabigatran etexilate mesylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0966454	PA2008008,C0966454	Lithuania	⤷ Sign Up	PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
2525812	2017034	Norway	⤷ Sign Up	PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: 20151124
2525812	PA2017021,C2525812	Lithuania	⤷ Sign Up	PRODUCT NAME: IDARUCIZUMABAS; REGISTRATION NO/DATE: EU/1/15/1056/001 20151120
2525812	32/2017	Austria	⤷ Sign Up	PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 (MITTEILUNG) 20151124
1870100	C300538	Netherlands	⤷ Sign Up	PRODUCT NAME: DABIGATRAN ETEXILAAT MESILAAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
2525812	300882	Netherlands	⤷ Sign Up	PRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056/001 20151124
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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