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Serving leading biopharmaceutical companies globally:

Fuji
Baxter
Johnson and Johnson
Cantor Fitzgerald
Boehringer Ingelheim
Citi
Farmers Insurance
Merck
Colorcon
Harvard Business School

Generated: October 19, 2017

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 eighteen 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 nine 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 NDA: 204026

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:18
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)

Summary 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:Feb 8, 2020
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
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

Expired Orange Book Patents for NDA: 204026

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-003Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-004Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-001Feb 8, 2013► Subscribe► Subscribe
Celgene
POMALYST
pomalidomide
CAPSULE;ORAL204026-002Feb 8, 2013► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo
Chinese Patent Office
UBS
Citi
McKesson
Colorcon
Mallinckrodt
Dow
Julphar

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.

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