POMALYST Drug Patent Profile

Which patents cover Pomalyst, 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^® Litigation and Generic Entry Outlook for Pomalyst

A generic version of POMALYST was approved as pomalidomide by APOTEX on June 11^th, 2024.

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:	83
Patent Applications:	2,650
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

See drug prices for POMALYST

Recent Clinical Trials for POMALYST

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

Sponsor	Phase
Megalabs	Phase 1
University of Chicago	Phase 2
Regeneron Pharmaceuticals	Phase 3

See all POMALYST clinical trials

Pharmacology for POMALYST

Drug Class

Thalidomide Analog

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

FDA Regulatory Exclusivity protecting POMALYST

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	AB	RX	Yes	Yes					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	AB	RX	Yes	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes					Y
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	AB	RX	Yes	No
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	AB	RX	Yes	No					Y

Expired US Patents for POMALYST

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

EU/EMA Drug Approvals for POMALYST

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

International Patents for POMALYST

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

Country	Patent Number	Title	Estimated Expiration
Japan	2013209407	POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE
South Korea	20060087543	POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE
Argentina	102756	FORMAS POLIMÓRFICAS DE 3-(4-AMINO-1-OXO-1,3-DIHIDRO-ISOINDOL-2-IL)-PIPERIDIN-2,6-DIONA Y COMPOSICIONES QUE LAS COMPRENDEN
Russian Federation	2010137395	СПОСОБЫ ПРИМЕНЕНИЯ 3-(4-АМИНО-1-ОКСО-1,3-ДИГИДРОИЗОИНДОЛ-2-ИЛ)ПИПЕРИДИН-2,6-ДИОНА ДЛЯ ЛЕЧЕНИЯ ОПРЕДЕЛЕННЫХ ТИПОВ ЛЕЙКОЗА
Canada	2476983	METHODES ET COMPOSITIONS FAISANT APPEL A DES COMPOSES IMMUNOMODULATEURS POUR LE TRAITEMENT ET LA PRISE EN CHARGE DES CANCERS ET D'AUTRESMALADIES (METHODS AND COMPOSITIONS USING IMMUNOMODULATORY COMPOUNDS FOR TREATMENT AND MANAGEMENT OF CANCERS AND OTHER DISEASES)

Supplementary Protection Certificates for POMALYST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2105135	212 50002-2015	Slovakia		PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2105135	1590004-6	Sweden		PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
2105135	5/2015	Austria		PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805
0925294	07C0056	France		PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070618
2105135	92642	Luxembourg		PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805