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Last Updated: June 24, 2024

Details for New Drug Application (NDA): 205437


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NDA 205437 describes OTEZLA, which is a drug marketed by Amgen Inc and is included in one NDA. It is available from one supplier. There are three 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:Amgen Inc
Ingredient:apremilast
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 205437
Mechanism of ActionPhosphodiesterase 4 Inhibitors
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 Amgen Inc 55513-137 55513-137-60 60 TABLET, FILM COATED in 1 BOTTLE (55513-137-60)
OTEZLA apremilast TABLET;ORAL 205437 NDA Amgen Inc 55513-137 55513-137-95 1 BLISTER PACK in 1 CARTON (55513-137-95) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 21, 2014TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jul 20, 2026
Regulatory Exclusivity Use:CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS
Regulatory Exclusivity Expiration:Dec 20, 2024
Regulatory Exclusivity Use:REVISIONS TO THE LABELING TO INCLUDE DATA FOR SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS, AND TO ALLOW FOR AN EXPANSION OF THE INDICATION
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
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 ⤷  Sign Up ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 ⤷  Sign Up ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 ⤷  Sign Up ⤷  Sign Up
Amgen Inc OTEZLA apremilast TABLET;ORAL 205437-002 Mar 21, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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