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Last Updated: July 4, 2020

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PRADAXA Drug 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 one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and sixty-six 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
Population Health Research InstitutePhase 4
The University of Hong KongPhase 4
University of ZurichPhase 3

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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 CAPSULE;ORAL 022512-001 Oct 19, 2010 AB RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-001 Oct 19, 2010 AB RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start 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
1485094 C20120023 00122 Estonia   Start Trial PRODUCT NAME: DABIGATRAANETEKSILAAT (MESUELAADINA);REG NO/DATE: K(2008)1180 20.03.2008
0966454 91437 Luxembourg   Start Trial 91437, EXPIRES: 20230216
0966454 C00966454/01 Switzerland   Start Trial PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
2525812 1790034-1 Sweden   Start Trial PRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
2525812 LUC00028 Luxembourg   Start Trial PRODUCT NAME: PRAXBIND - IDARUCIZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1056 20151124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Dow
AstraZeneca
Colorcon
Medtronic
Baxter

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