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Serving 500+ biopharmaceutical companies globally:

Argus Health
Fish and Richardson
US Army
Boehringer Ingelheim
US Department of Justice
Farmers Insurance

Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022512

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NDA 022512 describes PRADAXA, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PRADAXA profile page.

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.

Summary for NDA: 022512

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022512

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
dabigatran etexilate mesylate
CAPSULE;ORAL 022512 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0108 0597-0108-54 1 BOTTLE in 1 CARTON (0597-0108-54) > 60 CAPSULE in 1 BOTTLE
dabigatran etexilate mesylate
CAPSULE;ORAL 022512 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0108 0597-0108-60 10 BLISTER PACK in 1 CARTON (0597-0108-60) > 6 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Oct 19, 2010TE:RLD:Yes
Patent:► SubscribePatent Expiration:Dec 28, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Aug 31, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Sep 7, 2025Product Flag?YSubstance Flag?YDelist Request?

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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo

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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