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Last Updated: March 29, 2024

PRADAXA Drug Patent Profile


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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.

Drug patent expirations by year for PRADAXA
Drug Prices for PRADAXA

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Drug Sales Revenue Trends for PRADAXA

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Recent Clinical Trials for PRADAXA

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

SponsorPhase
PfizerPhase 1
Laval UniversityPhase 2
BayerPhase 1

See all PRADAXA clinical trials

Pharmacology for PRADAXA
Drug ClassDirect Thrombin Inhibitor
Mechanism of ActionThrombin 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

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

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
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-004 Jun 21, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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.

Country Patent Number Title Estimated Expiration
Hong Kong 1078792 ⤷  Try a Trial
Colombia 4920237 HETEROCICLICOS BICICLICOS DISUSTITUIDOS, SU PREPARACION Y MEDICAMENTOS QUE LOS CONTIENEN ⤷  Try a Trial
Croatia P980082 DISUBSTITUTED BICYCLIC HETEROCYCLES, THEIR PRODUCTION AND USE AS MEDICAMENTS ⤷  Try a Trial
Japan 5575923 ⤷  Try a Trial
Germany 19751939 ⤷  Try a Trial
Tunisia 2012000366 ANTICOAGULANT ANTIDOTES ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRADAXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2525812 122017000046 Germany ⤷  Try a Trial PRODUCT NAME: LDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 20151120
1870100 C01870100/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
1485094 CA 2012 00054 Denmark ⤷  Try a Trial PRODUCT NAME: DABIGATRAN-ETEXILAT OG SALTENE DERAF; SAERLIGT DABIGATRAN-ETEXILAT-MESYLAT; REG. NO/DATE: EU/1/08/442/009-014 20080318
1870100 C20120013 00068 Estonia ⤷  Try a Trial PRODUCT NAME: PRADAXA - DABIGATRAANETEKSILAAT (MESUELAADINA);REG NO/DATE: K(2008)1180 18.03.2008
0966454 C00966454/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
2525812 627 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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