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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Harvard Business School
AstraZeneca
Fuji
Mallinckrodt
Cerilliant
Daiichi Sankyo
Covington
QuintilesIMS
US Department of Justice

Generated: December 17, 2017

DrugPatentWatch Database Preview

PRADAXA Drug Profile

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Which patents cover Pradaxa, and what generic alternatives 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 eighty-four patent family members in fifty-one countries and fifteen supplementary protection certificates in eleven countries.

The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Drug patent expirations by year for PRADAXA

Medical Subject Heading (MeSH) Categories for PRADAXA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-001Oct 19, 2010RXYesNo► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-001Oct 19, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-001Oct 19, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-003Nov 20, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-003Nov 20, 2015RXYesNo► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-002Oct 19, 2010RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-002Oct 19, 2010RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-002Oct 19, 2010RXYesYes► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-001Oct 19, 2010RXYesNo► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-001Oct 19, 2010RXYesNo► Subscribe► SubscribeYY► Subscribe
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Paragraph IV (Patent) Challenges 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
6,469,039 Disubstituted bicyclic heterocycles, the preparation and the use thereof 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
Taiwan201202217► Subscribe
MontenegroP50608► Subscribe
Lithuania2525812► Subscribe
Germany19706229► Subscribe
China1088702► Subscribe
Hong Kong1173957► Subscribe
Austria430145► Subscribe
New Zealand578586► Subscribe
Germany122008000020► Subscribe
Australia2005318231► 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
0966454/01Switzerland► SubscribePRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
C020/2008Ireland► SubscribeSPC020/2008: 20090921, EXPIRES: 20230215
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
2008008,C0966454Lithuania► SubscribePRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
437Luxembourg► Subscribe91437, EXPIRES: 20230216
0349Netherlands► Subscribe300349, 20180216, EXPIRES: 20230215
0882Netherlands► SubscribePRODUCT NAME: IDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056/001 20151124
0Finland► Subscribe
2017000046Germany► SubscribePRODUCT NAME: LDARUCIZUMAB; REGISTRATION NO/DATE: EU/1/15/1056 20151120
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
AstraZeneca
US Department of Justice
Novartis
Julphar
Queensland Health
Colorcon
McKesson
Johnson and Johnson

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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