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Chinese Patent Office
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Generated: June 21, 2018

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 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-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 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 N 0597-0108-54
PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0108 N 0597-0108-60

Profile 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)
Patent:➤ Sign UpPatent Expiration:Dec 28, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OR TREATMENT OF VENOUS AND ARTERIAL THROMBOTIC DISEASE
Patent:➤ Sign UpPatent Expiration:Aug 31, 2027Product Flag?YSubstance Flag?Delist Request?Y

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Chubb
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Fish and Richardson
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