Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
Cipla
US Army
Harvard Business School
Colorcon
Federal Trade Commission
Cerilliant
Queensland Health
Novartis

Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022512

« Back to Dashboard
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

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022512

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRADAXA
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
PRADAXA
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
Regulatory Exclusivity Expiration:Nov 20, 2018
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE RE-NOVATE AND RE-NOVATE LL STUDIES (PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM FOLLOWING HIP REPLACEMENT SURGERY)
Regulatory Exclusivity Expiration:Apr 4, 2017
Regulatory Exclusivity Use:TO REDUCE THE RISK OF RECURRENCE OF DVT AND PE IN PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED
Regulatory Exclusivity Expiration:Apr 4, 2017
Regulatory Exclusivity Use:TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) IN PATIENTS WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR 5-10 DAYS


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Healthtrust
Moodys
Queensland Health
Medtronic
Colorcon
Cipla
Novartis
Citi
Cerilliant
Chinese Patent Office

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot