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Generated: December 11, 2017

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 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

Tradename:1
Applicant:1
Ingredient:1
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 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?


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