Details for New Drug Application (NDA): 204026

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NDA 204026 describes POMALYST, which is a drug marketed by Bristol and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the POMALYST profile page.

The generic ingredient in POMALYST is pomalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pomalidomide profile page.

Summary for 204026

Tradename:	POMALYST
Applicant:	Bristol
Ingredient:	pomalidomide
Patents:	4

Pharmacology for NDA: 204026

Suppliers and Packaging for NDA: 204026

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POMALYST	pomalidomide	CAPSULE;ORAL	204026	NDA	Celgene Corporation	59572-501	59572-501-00	100 CAPSULE in 1 BOTTLE (59572-501-00)
POMALYST	pomalidomide	CAPSULE;ORAL	204026	NDA	Celgene Corporation	59572-501	59572-501-21	21 CAPSULE in 1 BOTTLE (59572-501-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1MG
Approval Date:	Feb 8, 2013	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 20, 2023
Regulatory Exclusivity Use:	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Regulatory Exclusivity Expiration:	May 14, 2027
Regulatory Exclusivity Use:	FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
Regulatory Exclusivity Expiration:	May 14, 2027
Regulatory Exclusivity Use:	INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)

Expired US Patents for NDA 204026

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	⤷ Sign Up	⤷ Sign Up
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	⤷ Sign Up	⤷ Sign Up
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013	⤷ Sign Up	⤷ Sign Up
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	⤷ Sign Up	⤷ Sign Up
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013	⤷ Sign Up	⤷ Sign Up
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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