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Generated: November 14, 2018

DrugPatentWatch Database Preview

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 fifteen 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 ten 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:15
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204026
Generic Entry Date for 204026*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND BORTEZOMIB AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY.
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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:Feb 8, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Apr 23, 2018
Regulatory Exclusivity Use:POMALYST, IN COMBINATION WITH DEXAMETHASONE, IS INDICATED FOR PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 2 PRIOR THERAPIES AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
Regulatory Exclusivity Expiration:Feb 8, 2020
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND BORTEZOMIB AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY.

Expired US Patents for NDA 204026

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013 ➤ Sign Up ➤ Sign Up
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ➤ Sign Up ➤ Sign Up
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ➤ Sign Up ➤ Sign Up
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 ➤ Sign Up ➤ Sign Up
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013 ➤ Sign Up ➤ Sign Up
Celgene 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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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
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Queensland Health
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Julphar

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