➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Merck
AstraZeneca
Boehringer Ingelheim
Moodys

Last Updated: September 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205832

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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 five 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:5
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:Sep 6, 2026
Regulatory Exclusivity Use:INDICATED TO SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
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:Mar 9, 2023
Regulatory Exclusivity Use:TREATMENT FOR CHRONIC FIBROSING INTERSTITIAL LUNG DISEASES WITH A PROGRESSIVE PHENOTYPE

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Baxter
AstraZeneca
Mallinckrodt
Harvard Business School
Medtronic

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 verification 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.