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Generated: November 18, 2018

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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-six 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
Generic Entry Opportunity Date for 022512
Generic Entry Date for 022512*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

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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