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Last Updated: February 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 four patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and eleven 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. Seven 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

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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 four 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

Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-me- thyl-1 H-benzimidazol acid ethyl ester and the salts thereof
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 214358-004 Jun 21, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-003 Jun 21, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-005 Jun 21, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 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
Malaysia 143734 ADMINISTRATION FORM FOR THE ORAL APPLICATION OF 3-[(2-<[4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO]-METHYL>-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO]-PROPIONIC ACID ETHYL ESTER AND THE SALTS THEREOF ⤷  Try a Trial
Argentina 045520 METALSULFONATO DE ESTER ETILICO DEL ACIDO 3-[(2-{[4-(HEXILOXI-CARBONILAMINO-IMINO- METIL)-FENILAMINO] - METIL}-1-METIL -1H-BENCIMIDAZOL-5- CARBONIL ) - PIRIDIN -2-IL- AMINO] - PROPIONICO Y SU UTILIZACION COMO MEDICAMENTO ⤷  Try a Trial
Germany 19706229 ⤷  Try a Trial
South Africa 200406071 FORM OF PRESENTATION FOR 3-[(2-{[4-(HEXYLOXYCARBONYLAMINO-METHYL)-PHENY-LAMINO -METHYL-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO]PROPIONIC ACID ETHYL ESTER TO BE ADMINISTERED ORALLY ⤷  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
1485094 C300560 Netherlands ⤷  Try a Trial PRODUCT NAME: DABIGATRAN-ETEXILAAT, DESGEWENST IN DE VORM VAN EEN ZOUT-IN HET BIJZONDER DABIGATRAN-ETEXILAAT-MESYLAAT; REGISTRATION NO/DATE: EU/1/08/442/009-014 20110801
1870100 CA 2012 00027 Denmark ⤷  Try a Trial PRODUCT NAME: DABIGATRAN-ETEXILAT (SOM MESILAT); REG. NO/DATE: EU/1/08/442/001-002 20080318
1870100 1290025-4 Sweden ⤷  Try a Trial PRODUCT NAME: DABIGATRANETEXILATMESILAT; REG. NO/DATE: EU/1/08/442/001-008 20080318
2525812 CR 2017 00031 Denmark ⤷  Try a Trial PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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