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Serving leading biopharmaceutical companies globally:

Citi
Teva
Moodys
Argus Health
Express Scripts
McKesson
Julphar
Harvard Business School
Chinese Patent Office
Farmers Insurance

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022535

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NDA 022535 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 thirteen 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 022535
Tradename:ESBRIET
Applicant:Genentech Inc
Ingredient:pirfenidone
Patents:19
Formulation / Manufacturing:see details
Pharmacology for NDA: 022535
Ingredient-typePyridones
Suppliers and Packaging for NDA: 022535
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESBRIET pirfenidone CAPSULE;ORAL 022535 NDA Genentech, Inc. 50242-121 N 50242-121-01
ESBRIET pirfenidone CAPSULE;ORAL 022535 NDA Genentech, Inc. 50242-121 N 50242-121-87

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength267MG
Approval Date:Oct 15, 2014TE: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:➤ Sign UpPatent Expiration:Apr 22, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Baxter
Julphar
AstraZeneca
Fish and Richardson
Citi
Teva
Mallinckrodt
Queensland Health

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