Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim
Johnson and Johnson

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208780

« Back to Dashboard

NDA 208780 describes ESBRIET, which is a drug marketed by Genentech Inc and is included in two NDAs. It is available from two suppliers. There are twenty patents protecting this drug. Additional details are available on the ESBRIET profile page.

The generic ingredient in ESBRIET is pirfenidone. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.

Summary for 208780

Formulation / Manufacturing:see details

Pharmacology for NDA: 208780


Suppliers and Packaging for NDA: 208780

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESBRIET pirfenidone TABLET;ORAL 208780 NDA Genentech, Inc. 50242-122 50242-122-05 3 BOTTLE, PLASTIC in 1 CARTON (50242-122-05) > 90 TABLET, COATED in 1 BOTTLE, PLASTIC
ESBRIET pirfenidone TABLET;ORAL 208780 NDA Genentech, Inc. 50242-123 50242-123-01 1 BOTTLE, PLASTIC in 1 CARTON (50242-123-01) > 90 TABLET, COATED in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength267MG
Approval Date:Jan 11, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 16, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 15, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Apr 22, 2029Product Flag?Substance Flag?Delist Request?

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Express Scripts
Chinese Patent Office
Federal Trade Commission

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch: