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Serving leading biopharmaceutical companies globally:

Healthtrust
Federal Trade Commission
Johnson and Johnson
US Army
AstraZeneca
McKesson
Mallinckrodt
Colorcon
Moodys
Boehringer Ingelheim

Generated: December 16, 2017

DrugPatentWatch Database Preview

Dabigatran etexilate mesylate - Generic Drug Details

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What are the generic drug sources for dabigatran etexilate mesylate and what is the scope of dabigatran etexilate mesylate patent protection?

Dabigatran etexilate mesylate
is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dabigatran etexilate mesylate has one hundred and eighty-four patent family members in fifty-one countries and fifteen supplementary protection certificates in eleven countries.

There are twenty-three drug master file entries for dabigatran etexilate mesylate. Two suppliers are listed for this compound.

Medical Subject Heading (MeSH) Categories for dabigatran etexilate mesylate

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;ORAL022512-003Nov 20, 2015RXYesNo► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-003Nov 20, 2015RXYesNo► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-001Oct 19, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-003Nov 20, 2015RXYesNo► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-001Oct 19, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-001Oct 19, 2010RXYesNo► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-003Nov 20, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Boehringer IngelheimPRADAXAdabigatran etexilate mesylateCAPSULE;ORAL022512-001Oct 19, 2010RXYesNo► 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
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Non-Orange Book Patents for Generic Ingredient: dabigatran etexilate mesylate

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 Ingredient: dabigatran etexilate mesylate

Country Document Number Estimated Expiration
EcuadorSP066399► Subscribe
TaiwanI375674► Subscribe
Colombia6571889► Subscribe
Serbia49686► Subscribe
Norway334115► Subscribe
Yugoslavia38799► Subscribe
Saudi Arabia503► Subscribe
Czech Republic9902915► Subscribe
Slovenia0966454► Subscribe
TaiwanI513466► 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: DABIGATRAN ETEXILATE MESYLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
19/2008Austria► SubscribePRODUCT NAME: DABIGATRANETEXILAT UND DESSEN SALZE, INSBESONDERE DABIGATRANETEXILAT-MESILAT
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
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
C020/2008Ireland► SubscribeSPC020/2008: 20090921, EXPIRES: 20230215
0Finland► Subscribe
2008008,C0966454Lithuania► SubscribePRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REGISTRATION NO/DATE: EU/1/08/442/001-008 20080318
437Luxembourg► Subscribe91437, EXPIRES: 20230216
0966454/01Switzerland► SubscribePRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
2008 00032Denmark► Subscribe
2017 00031Denmark► SubscribePRODUCT NAME: IDARUCIZUMAB; REG. NO/DATE: EU/1/15/1056 20151124
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Federal Trade Commission
McKesson
Daiichi Sankyo
Johnson and Johnson
AstraZeneca
Cerilliant
Farmers Insurance
Boehringer Ingelheim
US Department of Justice

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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