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Generated: December 16, 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 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. 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
Generic Entry Opportunity Date for 022535
Generic Entry Date for 022535*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*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: 022535
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 50242-121-01 1 BOTTLE, PLASTIC in 1 CARTON (50242-121-01) > 270 CAPSULE in 1 BOTTLE, PLASTIC
ESBRIET pirfenidone CAPSULE;ORAL 022535 NDA Genentech, Inc. 50242-121 50242-121-87 1 BLISTER PACK in 1 CARTON (50242-121-87) > 63 CAPSULE in 1 BLISTER PACK

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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