Details for New Drug Application (NDA): 204026

✉ Email this page to a colleague

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. Three suppliers are 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:		RLD:	Yes
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)
Regulatory Exclusivity Expiration:	Nov 14, 2027
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 204026

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	6,561,977	⤷ Get Started Free
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	6,315,720	⤷ Get Started Free
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	6,908,432	⤷ Get Started Free
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	8,589,188	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.