POMALYST Drug Patent Profile

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When do Pomalyst patents expire, and when can generic versions of Pomalyst launch?

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

This drug has three hundred and fifty-seven patent family members in forty-eight 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.

DrugPatentWatch^® Generic Entry Outlook for Pomalyst

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

There have been twenty-eight 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.

There is one tentative approval for the generic drug (pomalidomide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for POMALYST

International Patents:	357
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	147
Clinical Trials:	82
Patent Applications:	2,650
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for POMALYST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for POMALYST
What excipients (inactive ingredients) are in POMALYST?	POMALYST excipients list
DailyMed Link:	POMALYST at DailyMed

Drug patent expirations by year for POMALYST

Recent Clinical Trials for POMALYST

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

Sponsor	Phase
University of Chicago	Phase 2
Regeneron Pharmaceuticals	Phase 3
Bristol-Myers Squibb	Phase 3

See all POMALYST clinical trials

Pharmacology for POMALYST

Drug Class	Thalidomide Analog

Anatomical Therapeutic Chemical (ATC) Classes for POMALYST

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for POMALYST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
POMALYST	Capsules	pomalidomide	1 mg, 2 mg, 3 mg and 4 mg	204026	6	2017-02-08

US Patents and Regulatory Information for POMALYST

POMALYST is protected by four US patents and five FDA Regulatory Exclusivities.

Patents protecting POMALYST

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting POMALYST

ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: ⤷ Sign Up

FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
Exclusivity Expiration: ⤷ Sign Up

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
Exclusivity Expiration: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013	⤷ Sign Up	⤷ Sign Up
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013	⤷ Sign Up	⤷ Sign Up
Bristol	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

EU/EMA Drug Approvals for POMALYST

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Imnovid (previously Pomalidomide Celgene)	pomalidomide	EMEA/H/C/002682 Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.	Authorised	no	no	no	2013-08-05
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for POMALYST

See the table below for patents covering POMALYST around the world.

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Country	Patent Number	Title	Estimated Expiration
Poland	195916		⤷ Sign Up
South Africa	200803700	Methods using 3-(4-amino-1oxo-1,3-dihydro-isoindol-2-yl)-piperdine-2,6-dione for treatment of certain leukemias	⤷ Sign Up
Hong Kong	1202531	-氨基- -氧代- 二氫-異吲哚- -基 -哌啶- -二酮的水合物 (HYDRATES OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE- 2,6-DIONE 3-(4--1--13 --2-)--2,6-)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for POMALYST

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0925294	C00925294/01	Switzerland	⤷ Sign Up	PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
0925294	07C0056	France	⤷ Sign Up	PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
0925294	91359	Luxembourg	⤷ Sign Up	91359, EXPIRES: 20220614
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description