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Serving 500+ biopharmaceutical companies globally:

Covington
Boehringer Ingelheim
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McKinsey
Teva
Johnson and Johnson
US Department of Justice
Baxter
Healthtrust
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Generated: June 23, 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 five 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 sixty-two patent family members in fifty-one countries.

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

Summary for Generic Name: dabigatran etexilate mesylate

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list22
Suppliers / Packagers: see list2
Bulk Api Vendors: see list44
Clinical Trials: see list655
Patent Applications: see list137
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dabigatran etexilate mesylate at DailyMed
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;ORAL022512-002Oct 19, 2010RXYesYes9,034,822► Subscribe ► Subscribe
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-002Oct 19, 2010RXYesYes7,866,474► SubscribeY ► Subscribe
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-002Oct 19, 2010RXYesYes► Subscribe► Subscribe
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-001Oct 19, 2010RXYesNo9,034,822► Subscribe ► Subscribe
Boehringer Ingelheim
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL022512-002Oct 19, 2010RXYesYes7,932,273► SubscribeYY ► 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
8,486,398Anticoagulant antidotes comprising antibodies that bind dabigatran and/or related compounds► Subscribe
6,414,008 Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions► 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
Uruguay33196► Subscribe
Taiwan201136606► Subscribe
Israel173885► Subscribe
China1088702► Subscribe
Canada2592057► 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
0349Netherlands► Subscribe300349, 20180216, EXPIRES: 20230215
2008008Lithuania► SubscribePRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REG. NO/DATE: EU/1/08/442/001-008 20080509
C020/2008Ireland► SubscribeSPC020/2008: 20090921, EXPIRES: 20230215
0966454/01Switzerland► SubscribePRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012
2008 00032Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Teva
Citi
Federal Trade Commission
Harvard Business School
Merck
AstraZeneca
Accenture
Cipla
Express Scripts
Farmers Insurance

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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