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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Covington
Citi
McKinsey
Mallinckrodt
Federal Trade Commission
Daiichi Sankyo
Chinese Patent Office

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208780

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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 sixteen 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
Tradename:ESBRIET
Applicant:Genentech Inc
Ingredient:pirfenidone
Patents:16
Formulation / Manufacturing:see details
Pharmacology for NDA: 208780
Ingredient-typePyridones
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 N 50242-122-05
ESBRIET pirfenidone TABLET;ORAL 208780 NDA Genentech, Inc. 50242-122 N 50242-122-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength267MG
Approval Date:Jan 11, 2017TE: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:➤ Try a Free TrialPatent Expiration:Apr 22, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE THEN FULL DAY DAILY DOSE IN TREATMENT OF IPF

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Daiichi Sankyo
Chinese Patent Office
Fish and Richardson
Colorcon
Mallinckrodt
Baxter
QuintilesIMS
Farmers Insurance

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