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PRADAXA Drug Profile

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Which patents cover Pradaxa, and what substitute generic drugs are available?

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

This drug has one hundred and fifty-eight patent family members in forty-nine countries.

The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-one 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.

Summary for Tradename: PRADAXA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list86
Clinical Trials: see list20
Patent Applications: see list95
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:PRADAXA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-001Oct 19, 2010RXYesNo9,034,822► Subscribe ► Subscribe
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-001Oct 19, 2010RXYesNo► Subscribe► Subscribe
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-001Oct 19, 2010RXYesNo7,866,474► SubscribeY ► Subscribe
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-003Nov 20, 2015RXYesNo► Subscribe► Subscribe
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-003Nov 20, 2015RXYesNo9,034,822► Subscribe ► Subscribe
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Paragraph IV activity for: PRADAXA

Drugname Dosage Strength RLD Submissiondate
dabigatran etexilate mesylateCapsuleseq. to 110 mg basePradaxa12/15/2015
dabigatran etexilate mesylateCapsuleseq. to 75 mg base and 150 mg basePradaxa10/20/2014

Non-Orange Book Patents for Tradename: PRADAXA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,414,008 Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions► Subscribe
8,486,398Anticoagulant antidotes comprising antibodies that bind dabigatran and/or related compounds► Subscribe
6,469,039 Disubstituted bicyclic heterocycles, the preparation and the use thereof as pharmaceutical compositions► Subscribe
6,710,055 Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: PRADAXA

Country Document Number Estimated Expiration
Japan2007504106► Subscribe
Argentina010896► Subscribe
Austria529420► Subscribe
Germany502004009431► Subscribe
Norway20072669► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PRADAXA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0025France► SubscribePRODUCT NAME: DABIGATRAN - ETEXILATE ET SES SELS EN PARTICULIER DABIGATRAN ETEXILATE MESILATE; REGISTRATION NO/DATE IN FRANCE: EU/1/08/442/001 DU 20080318; REGISTRATION NO/DATE AT EEC: EU/1/08/442/001 DU 20080318
437Luxembourg► Subscribe91437, EXPIRES: 20230216
0966454/01Switzerland► SubscribePRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
C/GB08/037United Kingdom► SubscribePRODUCT NAME: DABIGATRAN ETEXILATE, OPTIONALLY IN THE FORM OF A SALT, PREFERABLY DABIGATRAN ETEXILATE MESYLATE; REGISTERED: UK EU/1/08/442/001 20080318; UK EU/1/08/442/002 20080318; UK EU/1/08/442/003 20080318; UK EU/1/08/442/004 20080318; UK EU/1/08/442/005 20080318; UK EU/1/08/442/006 20080318; UK EU/1/08/442/007 20080318; UK EU/1/08/442/008 20080318
2008008Lithuania► SubscribePRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REG. NO/DATE: EU/1/08/442/001-008 20080509
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