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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

PRADAXA Drug Patent Profile


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Which patents cover Pradaxa, and when can generic versions of Pradaxa launch?

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

This drug has two hundred and sixty-seven patent family members in fifty-two countries.

The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Three 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
Laval UniversityPhase 2
Institute of Cardiology, Warsaw, PolandPhase 4
Poznan University of Medical SciencesPhase 4

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Pharmacology for PRADAXA
Paragraph IV (Patent) Challenges for PRADAXA
Tradename Dosage Ingredient NDA Submissiondate
PRADAXA CAPSULE;ORAL dabigatran etexilate mesylate 022512 2015-12-15
PRADAXA CAPSULE;ORAL dabigatran etexilate mesylate 022512 2014-10-20

US Patents and Regulatory Information for 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 214358-004 Jun 21, 2021 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-003 Jun 21, 2021 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-006 Jun 21, 2021 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-005 Jun 21, 2021 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for PRADAXA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1870100 1290025-4 Sweden ⤷  Free Forever Trial PRODUCT NAME: DABIGATRANETEXILATMESILAT; REG. NO/DATE: EU/1/08/442/001-008 20080318
0966454 300349 Netherlands ⤷  Free Forever Trial 300349, 20180216, EXPIRES: 20230215
1485094 PA2012021 Lithuania ⤷  Free Forever Trial PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/009 - EU/1/08/442/014 20110801
0966454 SZ 19/2008 Austria ⤷  Free Forever Trial PRODUCT NAME: DABIGATRANETEXILAT UND DESSEN SALZE, INSBESONDERE DABIGATRANETEXILAT-MESILAT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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