PRADAXA Drug Patent Profile

✉ Email this page to a colleague

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.

Try a Trial

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

Drug patent expirations by year 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

Film container
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting PRADAXA

TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED
Exclusivity Expiration: ⤷ Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial

NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Try a Trial
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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-006	Jun 21, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	CAPSULE;ORAL	022512-001	Oct 19, 2010	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	PRADAXA	dabigatran etexilate mesylate	PELLETS;ORAL	214358-002	Jun 21, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 PRADAXA

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

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Croatia	P20090311		⤷ Try a Trial
Argentina	079944	ANTICUERPO NEUTRALIZANTE DE LA ACTIVIDAD DE UN ANTICOAGULANTE	⤷ Try a Trial
Norway	326918		⤷ Try a Trial
Colombia	5660265	METANOSULFONATO DEL ESTER ETILICO DEL ACIDO 3-[(2-{[4-(HEXILOXI-CARBONILAMINO-IMINO-METIL)-FENILAMINO]-METIL}-1-METIL-1H-BENCI-MIDAZOL-5-CARBONIL)-PIRIDIN-2-IL-AMINO]-PROPIONICO Y SU UTILIZACION COMO MEDICAMENTO	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PRADAXA

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1870100	122012000047	Germany	⤷ Try a Trial	PRODUCT NAME: DABIGATRAN ETEXILAT MESILAT = 3-((2-((4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO)-METHYL)-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO)-PROPIONSAEURE-ETHYLESTER-METHANSULFONAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
1485094	PA2012021	Lithuania	⤷ Try a Trial	PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/009 - EU/1/08/442/014 20110801
0966454	330	Finland	⤷ Try a Trial
1870100	300538	Netherlands	⤷ Try a Trial	PRODUCT NAME: DABIGATRAN ETEXILAAT MESILAAT; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description