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Daiichi Sankyo
Federal Trade Commission
Queensland Health
Covington
Dow
Colorcon
Julphar
Citi
Fish and Richardson

Generated: June 21, 2018

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 four patents protecting this drug. Additional details are available on the OFEV profile page.

The generic ingredient in OFEV is nintedanib esylate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nintedanib esylate profile page.
Summary for 205832
Tradename:OFEV
Applicant:Boehringer Ingelheim
Ingredient:nintedanib esylate
Patents:4
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
OFEV nintedanib esylate CAPSULE;ORAL 205832 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0143 N 0597-0143-60
OFEV nintedanib esylate CAPSULE;ORAL 205832 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0145 N 0597-0145-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Oct 15, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 15, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 15, 2021
Regulatory Exclusivity Use:TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Patent:➤ Sign UpPatent Expiration:Dec 10, 2020Product Flag?YSubstance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
UBS
Baxter
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McKesson
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