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Last Updated: December 5, 2019

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 six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OFEV profile page.

The generic ingredient in OFEV is nintedanib esylate. There are nine 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:6
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 205832
Generic Entry Date for 205832*:
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.

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 0597-0143-60 1 BOTTLE in 1 CARTON (0597-0143-60) > 60 CAPSULE in 1 BOTTLE
OFEV 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
Paragraph IV (Patent) Challenges for 205832
Tradename Dosage Ingredient NDA Submissiondate
OFEV CAPSULE;ORAL nintedanib esylate 205832 2018-10-15

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:Sep 6, 2022
Regulatory Exclusivity Use:SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE
Regulatory Exclusivity Expiration:Oct 15, 2021
Regulatory Exclusivity Use:TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS

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