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Serving leading biopharmaceutical companies globally:

McKesson
Argus Health
Fuji
Daiichi Sankyo
Colorcon
Farmers Insurance
Julphar
Healthtrust
Express Scripts
Accenture

Generated: February 22, 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 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 208780
Tradename:ESBRIET
Applicant:Genentech Inc
Ingredient:pirfenidone
Patents:15
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

Expired US Patents for NDA 208780

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 ➤ Try a Free Trial ➤ Try a Free Trial
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Fuji
Farmers Insurance
AstraZeneca
Dow
Cantor Fitzgerald
US Army
Federal Trade Commission
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 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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