.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

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 three 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-one 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 NDA: 022512

Tradename:
PRADAXA
Applicant:
Boehringer Ingelheim
Ingredient:
dabigatran etexilate mesylate
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 0597-0108-60 10 BLISTER PACK in 1 CARTON (0597-0108-60) > 6 CAPSULE in 1 BLISTER PACK
PRADAXA
dabigatran etexilate mesylate
CAPSULE;ORAL 022512 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0135 0597-0135-12 2 BLISTER PACK in 1 CARTON (0597-0135-12) > 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:No
Patent:7,866,474Patent Expiration:Aug 31, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:7,932,273Patent Expiration:Sep 7, 2025Product Flag?YSubstance Flag?YDelist Request?
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)


Complete Access Available with Subscription
« Back to Dashboard

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

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.

`abc