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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022458

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NDA 022458 describes ELELYSO, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ELELYSO profile page.

The generic ingredient in ELELYSO is taliglucerase alfa. One supplier is listed for this compound. Additional details are available on the taliglucerase alfa profile page.

Summary for 022458


Pharmacology for NDA: 022458


Suppliers and Packaging for NDA: 022458

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELELYSO taliglucerase alfa POWDER;IV (INFUSION) 022458 NDA Pfizer Laboratories Div Pfizer Inc 0069-0106 0069-0106-01 1 VIAL, GLASS in 1 BOX (0069-0106-01) > 5 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength200 UNITS/VIAL
Approval Date:May 1, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:May 1, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 27, 2017
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:► SubscribePatent Expiration:Feb 24, 2024Product Flag?YSubstance Flag?YDelist Request?

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