PRADAXA Drug Patent Profile

Which patents cover Pradaxa, and what generic alternatives are available?

Pradaxa is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and forty-two patent family members in forty-four countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pradaxa

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

Summary for PRADAXA

International Patents:	142
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	55
Drug Prices:	Drug price information for PRADAXA
Drug Sales Revenues:	Drug sales revenues for PRADAXA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRADAXA
What excipients (inactive ingredients) are in PRADAXA?	PRADAXA excipients list
DailyMed Link:	PRADAXA at DailyMed

See drug prices for PRADAXA

See drug sales revenues for PRADAXA

Recent Clinical Trials for PRADAXA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 1
Laval University	Phase 2
Bayer	Phase 1

See all PRADAXA clinical trials

Pharmacology for PRADAXA

Drug Class	Direct Thrombin Inhibitor
Mechanism of Action	Thrombin Inhibitors

Paragraph IV (Patent) Challenges for PRADAXA

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 PRADAXA

PRADAXA is protected by three US patents and three FDA Regulatory Exclusivities.

Patents protecting PRADAXA

FDA Regulatory Exclusivity protecting PRADAXA

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	214358-005	Jun 21, 2021		RX	Yes	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-006	Jun 21, 2021		RX	Yes	Yes					Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-001	Oct 19, 2010	AB	RX	Yes	No					Y
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-002	Jun 21, 2021		RX	Yes	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-004	Jun 21, 2021		RX	Yes	No
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-003	Nov 20, 2015	AB	RX	Yes	No					Y

International Patents for PRADAXA

See the table below for patents covering PRADAXA around the world.

Country	Patent Number	Title	Estimated Expiration
Chile	2012001927	Anticuerpo capaz de neutralizar la actividad de un anticoagulante de dabigatran; método de fabricación de anticuerpo; kit que comprende al anticuerpo.
European Patent Office	2525812	ANTIDOTES D'ANTICOAGULANTS (ANTICOAGULANT ANTIDOTES)
Japan	2013517317
Argentina	079944	ANTICUERPO NEUTRALIZANTE DE LA ACTIVIDAD DE UN ANTICOAGULANTE
Malaysia	162323	ANTICOAGULANT ANTIDOTES
Israel	209368	METHANESULFONATE SALT OF ETHYL 3-[(2-{[4-(HEXYLOXYCARBONYLAMINO - IMINO - METHYL)- PHENYLAMINO] METHYL} - 1 - METHYL- 1H - BENZIMIDAZOL - 5 - CARBONYL) - PYRIDIN - 2 - YL - AMINO] PROPIONATE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME

Supplementary Protection Certificates for PRADAXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2525812	122017000046	Germany		PRODUCT NAME: LDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 20151120
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
2525812	LUC00028	Luxembourg		PRODUCT NAME: PRAXBIND - IDARUCIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1056 20151124
1485094	C20120023 00122	Estonia		PRODUCT NAME: DABIGATRAANETEKSILAAT (MESUELAADINA);REG NO/DATE: K(2008)1180 20.03.2008
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