Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: September 18, 2019

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 ten 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:10
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, 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.
Patent:  Try a Free TrialPatent Expiration:Oct 23, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
Patent:  Try a Free TrialPatent Expiration:Oct 23, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE

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   Try a Free Trial   Try a Free Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013   Try a Free Trial   Try a Free Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013   Try a Free Trial   Try a Free Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-002 Feb 8, 2013   Try a Free Trial   Try a Free Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013   Try a Free Trial   Try a Free Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-001 Feb 8, 2013   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Mallinckrodt
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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. thinkBiotech performs no independent verifification 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.