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Last Updated: February 4, 2023

Details for New Drug Application (NDA): 204026


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NDA 204026 describes POMALYST, which is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are six 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:Celgene
Ingredient:pomalidomide
Patents:6
Formulation / Manufacturing:see details
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:RXDosage:CAPSULE;ORALStrength1MG
Approval Date:Feb 8, 2013TE: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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 See Plans and Pricing See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 See Plans and Pricing See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 See Plans and Pricing See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 See Plans and Pricing See Plans and Pricing
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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