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Last Updated: July 6, 2020

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 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 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
Paragraph IV (Patent) Challenges for 022535
Tradename Dosage Ingredient NDA Submissiondate
ESBRIET CAPSULE;ORAL pirfenidone 022535 2018-10-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength267MG
Approval Date:Oct 15, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 15, 2021
Regulatory Exclusivity Use:TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Patent:  Start TrialPatent Expiration:Apr 22, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
Patent:  Start TrialPatent Expiration:Apr 22, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS

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