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

Pharmacology for NDA: 205437

Mechanism of Action	Phosphodiesterase 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:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 21, 2014	TE:	AB	RLD:	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:	Apr 25, 2027
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Jan 19, 2027
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 205437

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-001	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	205437-001	Mar 21, 2014	⤷ Sign Up	⤷ Sign Up
Amgen Inc	OTEZLA	apremilast	TABLET;ORAL	205437-003	Mar 21, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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