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PRADAXA Drug Profile

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

This drug has one hundred and fifty-six 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
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-001Oct 19, 2010RXNo6,087,380► subscribeYY ► subscribe
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-002Oct 19, 2010RXYes► subscribe► subscribe
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-001Oct 19, 2010RXNo7,866,474► subscribeY ► 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
6,710,055 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
South Korea20130041381► subscribe
European Patent Office2525812► subscribe
Canada2277949► 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
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
C020/2008Ireland► subscribeSPC020/2008: 20090921, EXPIRES: 20230215
437Luxembourg► subscribe91437, EXPIRES: 20230216
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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