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Serving leading biopharmaceutical companies globally:

Baxter
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US Army
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Covington
AstraZeneca
Dow
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Generated: December 13, 2017

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 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

Tradename:1
Applicant:1
Ingredient:1
Patents:9
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 59572-630-27 1 KIT in 1 BLISTER PACK (59572-630-27)
OTEZLA apremilast TABLET;ORAL 205437 NDA Celgene Corporation 59572-630 59572-630-99 1 KIT in 1 BLISTER PACK (59572-630-99)

Summary 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
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:► SubscribePatent Expiration:Oct 30, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4


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Serving leading biopharmaceutical companies globally:

Argus Health
Dow
Johnson and Johnson
Farmers Insurance
Novartis
Deloitte
Julphar
McKinsey
Fuji
Merck

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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