➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Medtronic
Boehringer Ingelheim
Baxter
Mallinckrodt

Last Updated: August 3, 2020

DrugPatentWatch Database Preview

POMALYST Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

When do Pomalyst patents expire, and what generic alternatives are available?

Pomalyst is a drug marketed by Celgene and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and seventy-two patent family members in forty-seven countries.

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.

US ANDA Litigation and Generic Entry Outlook for Pomalyst

Pomalyst was eligible for patent challenges on February 8, 2017.

There have been twenty-nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Drug patent expirations by year for POMALYST
Drug Prices for POMALYST

See drug prices for POMALYST

Recent Clinical Trials for POMALYST

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Medical College of WisconsinPhase 1
Janssen Research & Development, LLCPhase 2
Andrew Yee, MDPhase 2

See all POMALYST clinical trials

Pharmacology for POMALYST
Paragraph IV (Patent) Challenges for POMALYST
Tradename Dosage Ingredient NDA Submissiondate
POMALYST CAPSULE;ORAL pomalidomide 204026 2017-02-08

US Patents and Regulatory Information for POMALYST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-003 Feb 8, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Celgene POMALYST pomalidomide CAPSULE;ORAL 204026-004 Feb 8, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for POMALYST

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

Supplementary Protection Certificates for POMALYST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2105135 300717 Netherlands   Start Trial PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135 122015000013 Germany   Start Trial PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294 56/2007 Austria   Start Trial PRODUCT NAME: 1-OXO-2(2,6-DIOXOPIPERIDIN-3-YL)-4- AMINOISOINDOLIN, AUCH 3-(4'AMINOISOINDOLIN-1'-ON)- 1-PIPERIDIN-2,6DION GENANNT, GEGEBENENFALLS IN FORM EINES SAEUREADDITIONSSALZES; REGISTRATION NO/DATE: EU/1/07/391/001 - EU/1/07/391/004 20070614
2105135 C300717 Netherlands   Start Trial PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
AstraZeneca
McKesson
Dow
Johnson and Johnson

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 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.