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Serving leading biopharmaceutical companies globally:

Merck
Accenture
Farmers Insurance
McKesson
Deloitte
Baxter
Express Scripts
Citi
Colorcon
Daiichi Sankyo

Generated: October 20, 2017

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. 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 NDA: 022535

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:19
Formulation / Manufacturing:see details

Pharmacology for NDA: 022535

Ingredient-typePyridones

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 50242-121-02 1 BLISTER PACK in 1 CARTON (50242-121-02) > 63 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength267MG
Approval Date:Oct 15, 2014TE: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?
Patented Use:DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS


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Serving leading biopharmaceutical companies globally:

Moodys
Queensland Health
McKesson
Boehringer Ingelheim
Citi
Teva
Fish and Richardson
Baxter
Federal Trade Commission
UBS

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