PRADAXA Drug Patent Profile

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

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. 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 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:	3
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	55
Patent Applications:	96
Formulation / Manufacturing:	see details
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

Anatomical Therapeutic Chemical (ATC) Classes for PRADAXA

B01AE	Direct thrombin inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-001	Oct 19, 2010	AB	RX	Yes	No

International Patents for PRADAXA

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

Country	Patent Number	Title	Estimated Expiration
Australia	6399198
Denmark	2060569
Czech Republic	297768	Disubstituované bicyklické heterocyklické deriváty (Disubstituted bicyclic heterocyclic derivatives)
Serbia	52088	OBLIK ZA ORALNU PRIMENU ETILESTRA 3-[(2-{[4-(HEKSILOKSIKARBONILAMINO-IMINO-METIL)-FENILAMINO]-METIL}-1-METIL-1H-BENZIMIDAZOL-5-KARBONIL)-PIRIDIN-2-IL-AMINO]PROPIONSKE KISELINE I NJEGOVIH SOLI (FORM OF PRESENTATION FOR 3-/(2-(/4-(HEXYLOXYCARBONYLAMINO- IMINO-METHYL)-PHENYLAMINO/-METHYL)-1-METHYL-1H-BENZIMIDAZOL -5-CARBONYL)PYRIDIN-2-YL-AMINO/PROPIONIC ACID ETHYL ESTER TO BE ADMINISTERED ORALLY)
New Zealand	556336	Blister card with two parallel lines of weakness transverse to central line of weakness
Norway	334115
Poland	394601

Supplementary Protection Certificates for PRADAXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0966454	CA 2008 00032	Denmark
0966454	PA2008008,C0966454	Lithuania		PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
2525812	627	Finland
2525812	CA 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
1870100	92025	Luxembourg		92025, EXPIRES: 20230318
1870100	300538	Netherlands		PRODUCT NAME: DABIGATRAN ETEXILAAT MESILAAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318