➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Medtronic
Baxter
Express Scripts
Mallinckrodt

Last Updated: July 2, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022512


Email this page to a colleague

» See Plans and Pricing

« 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 three suppliers. There are five 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-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Summary for 022512
Tradename:PRADAXA
Applicant:Boehringer Ingelheim
Ingredient:dabigatran etexilate mesylate
Patents:5
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022512
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
Paragraph IV (Patent) Challenges for 022512
Tradename Dosage Ingredient NDA Submissiondate
PRADAXA CAPSULE;ORAL dabigatran etexilate mesylate 022512 2015-12-15
PRADAXA CAPSULE;ORAL dabigatran etexilate mesylate 022512 2014-10-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Oct 19, 2010TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 28, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OR TREATMENT OF VENOUS AND ARTERIAL THROMBOTIC DISEASE
Patent:  Start TrialPatent Expiration:Aug 31, 2027Product Flag?YSubstance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Sep 7, 2025Product Flag?YSubstance Flag?YDelist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Johnson and Johnson
Express Scripts
Colorcon
Medtronic

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 verification 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.