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Last Updated: November 13, 2019

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 eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OTEZLA profile page.

The generic ingredient in OTEZLA is apremilast. There are twenty-eight 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:11
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 205437
Generic Entry Date for 205437*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)
Paragraph IV (Patent) Challenges for 205437
Tradename Dosage Ingredient NDA Submissiondate
OTEZLA TABLET;ORAL apremilast 205437 2018-03-22

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
Regulatory Exclusivity Expiration:Jul 19, 2022
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE
Regulatory Exclusivity Expiration:Jul 19, 2026
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE

Expired US Patents for NDA 205437

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-001 Mar 21, 2014   Start Trial   Start Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014   Start Trial   Start Trial
Celgene Corp OTEZLA apremilast TABLET;ORAL 205437-003 Mar 21, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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