DABIGATRAN ETEXILATE MESYLATE Drug Patent Profile

When do Dabigatran Etexilate Mesylate patents expire, and what generic alternatives are available?

Dabigatran Etexilate Mesylate is a drug marketed by Alkem Labs Ltd, Apotex, and Hetero Labs Ltd Iii. and is included in three NDAs.

The generic ingredient in DABIGATRAN ETEXILATE MESYLATE is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dabigatran Etexilate Mesylate

A generic version of DABIGATRAN ETEXILATE MESYLATE was approved as dabigatran etexilate mesylate by ALKEM LABS LTD on March 11^th, 2020.

Summary for DABIGATRAN ETEXILATE MESYLATE

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	6
Patent Applications:	141
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DABIGATRAN ETEXILATE MESYLATE
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

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
Alkem Labs Ltd	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208040-001	Mar 11, 2020	AB	RX	No	No
Hetero Labs Ltd Iii	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	207961-002	May 6, 2020	AB	RX	No	No
Apotex	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208070-002	Dec 15, 2023	AB	RX	No	No
Alkem Labs Ltd	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208040-002	Mar 11, 2020	AB	RX	No	No
Apotex	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208070-001	Dec 15, 2023	AB	RX	No	No
Hetero Labs Ltd Iii	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	207961-001	May 6, 2020	AB	RX	No	No
Apotex	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208070-003	Dec 15, 2023	AB	RX	No	No