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Fuji
McKesson
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Express Scripts
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Cantor Fitzgerald
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Accenture
AstraZeneca
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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

Tradename:1
Applicant:1
Ingredient:1
Patents:3

Pharmacology for NDA: 022458

Ingredient-typeGlucosylceramidase

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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Serving leading biopharmaceutical companies globally:

Deloitte
Cerilliant
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US Army
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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