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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. One supplier is listed for this compound. Additional details are available on the nintedanib esylate profile page.

Summary for NDA: 205832

Tradename:
OFEV
Applicant:
Boehringer Ingelheim
Ingredient:
nintedanib esylate
Patents:3
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 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Oct 15, 2014TE:RLD:No
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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