DABIGATRAN Drug Patent Profile

When do Dabigatran patents expire, and when can generic versions of Dabigatran launch?

Dabigatran is a drug marketed by Alembic, Alkem Labs Ltd, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys, Hetero Labs Ltd Iii, MSN, and Mylan. and is included in nine NDAs.

The generic ingredient in DABIGATRAN is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Eighteen 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

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

Summary for DABIGATRAN

US Patents:	0
Applicants:	9
NDAs:	9
Drug Prices:	Drug price information for DABIGATRAN
DailyMed Link:	DABIGATRAN at DailyMed

See drug prices for DABIGATRAN

See drug sales revenues for DABIGATRAN

US Patents and Regulatory Information for DABIGATRAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	215233-001	Jun 14, 2024	AB	RX	No	No
Dr Reddys	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208048-003	Jan 28, 2025	AB	RX	No	No
Msn	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	213879-002	May 22, 2024	AB	RX	No	No
Apotex	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208070-001	Dec 15, 2023	AB	RX	No	No
Alkem Labs Ltd	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208040-001	Mar 11, 2020	AB	RX	No	No
Aurobindo Pharma	DABIGATRAN ETEXILATE MESYLATE	dabigatran etexilate mesylate	CAPSULE;ORAL	208039-003	May 14, 2025	AB	RX	No	No