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Generated: May 30, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205832

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NDA 205832 describes OFEV, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the OFEV profile page.

The generic ingredient in OFEV is nintedanib esylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nintedanib esylate profile page.

Summary for NDA: 205832

Formulation / Manufacturing:see details

Pharmacology for NDA: 205832

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 205832

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
nintedanib esylate
CAPSULE;ORAL 205832 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0143 0597-0143-60 1 BOTTLE in 1 CARTON (0597-0143-60) > 60 CAPSULE in 1 BOTTLE
nintedanib esylate
CAPSULE;ORAL 205832 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0145 0597-0145-60 1 BOTTLE in 1 CARTON (0597-0145-60) > 60 CAPSULE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Oct 15, 2014TE:RLD:Yes
Patent:6,762,180Patent Expiration:Dec 10, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:7,119,093Patent Expiration:Feb 21, 2024Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Oct 15, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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