Generated: December 13, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205437
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, which is a drug marketed by Celgene Corp and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the OTEZLA profile page.
The generic ingredient in OTEZLA is apremilast. There are fifteen 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
|Formulation / Manufacturing:||see details|
Pharmacology for NDA: 205437
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Summary for product number 001
|Approval Date:||Mar 21, 2014||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Mar 21, 2019
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Sep 23, 2017
|Regulatory Exclusivity Use:||TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY|
|Patent:||► Subscribe||Patent Expiration:||Oct 30, 2018||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
|Patented Use:||USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4|
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