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Last Updated: February 28, 2020

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 one supplier. There are twenty-one patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ESBRIET profile page.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pirfenidone profile page.
Summary for 208780
Applicant:Genentech Inc
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208780
Generic Entry Date for 208780*:
Constraining patent/regulatory exclusivity:

*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: 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 50242-122-06 1 BOTTLE, PLASTIC in 1 CARTON (50242-122-06) > 270 TABLET, COATED in 1 BOTTLE, PLASTIC
ESBRIET pirfenidone TABLET;ORAL 208780 NDA Genentech, Inc. 50242-122 50242-122-86 1 BOTTLE, PLASTIC in 1 CARTON (50242-122-86) > 189 TABLET, COATED in 1 BOTTLE, PLASTIC
Paragraph IV (Patent) Challenges for 208780
Tradename Dosage Ingredient NDA Submissiondate
ESBRIET TABLET;ORAL pirfenidone 208780 2018-10-15

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
Patent:  Start TrialPatent Expiration:Mar 28, 2037Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Express Scripts
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