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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Covington
Teva
Deloitte
Accenture
Boehringer Ingelheim
Cerilliant
Daiichi Sankyo
Colorcon

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205437

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NDA 205437 describes OTEZLA, which is a drug marketed by Celgene Corp and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the OTEZLA profile page.

The generic ingredient in OTEZLA is apremilast. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the apremilast profile page.
Summary for 205437
Tradename:OTEZLA
Applicant:Celgene Corp
Ingredient:apremilast
Patents:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 205437
Suppliers and Packaging for NDA: 205437
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OTEZLA apremilast TABLET;ORAL 205437 NDA Celgene Corporation 59572-630 N 59572-630-27
OTEZLA apremilast TABLET;ORAL 205437 NDA Celgene Corporation 59572-630 N 59572-630-99

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 21, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 21, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Oct 30, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
Patent:➤ Sign UpPatent Expiration:Mar 19, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Julphar
Federal Trade Commission
Harvard Business School
Dow
Chinese Patent Office
Covington
Accenture

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