Generated: December 13, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022535
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, 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 022535
|Formulation / Manufacturing:||see details|
Pharmacology for NDA: 022535
Suppliers and Packaging for NDA: 022535
||National Drug Code
||1 BOTTLE, PLASTIC in 1 CARTON (50242-121-01) > 270 CAPSULE in 1 BOTTLE, PLASTIC
||1 BLISTER PACK in 1 CARTON (64116-121-02) > 63 CAPSULE in 1 BLISTER PACK
|Complete Access Available with Subscription
Summary for product number 001
|Approval Date:||Oct 15, 2014||TE:||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:||► Subscribe||Patent Expiration:||Apr 22, 2029||Product Flag?||Substance Flag?||Delist Request?|
|Patented Use:||DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS|
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