POMALIDOMIDE - Generic Drug Details

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What are the generic drug sources for pomalidomide and what is the scope of freedom to operate?

Pomalidomide is the generic ingredient in two branded drugs marketed by Apotex, Breckenridge, Eugia Pharma, Hetero Labs Ltd V, Mylan, Teva Pharms Usa, and Bristol, and is included in seven NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pomalidomide has three hundred and fifty-seven patent family members in forty-eight countries.

There are eleven drug master file entries for pomalidomide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for POMALIDOMIDE

International Patents:	357
US Patents:	4
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	147
Clinical Trials:	253
Patent Applications:	5,655
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for POMALIDOMIDE
What excipients (inactive ingredients) are in POMALIDOMIDE?	POMALIDOMIDE excipients list
DailyMed Link:	POMALIDOMIDE at DailyMed

Recent Clinical Trials for POMALIDOMIDE

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

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

See all POMALIDOMIDE clinical trials

Generic filers with tentative approvals for POMALIDOMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	2MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	1MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	4MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for POMALIDOMIDE

Drug Class	Thalidomide Analog

Anatomical Therapeutic Chemical (ATC) Classes for POMALIDOMIDE

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

Paragraph IV (Patent) Challenges for POMALIDOMIDE

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 POMALIDOMIDE

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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	204026-001	Feb 8, 2013	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Hetero Labs Ltd V	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	210236-001	Sep 26, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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 POMALIDOMIDE

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

EU/EMA Drug Approvals for POMALIDOMIDE

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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 POMALIDOMIDE

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Country	Patent Number	Title	Estimated Expiration
Canada	2537092	FORMES POLYMORPHES DE 3-(4-AMINO-1-OXO-1,3-DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE)	⤷ Sign Up
Eurasian Patent Organization	009922	ПОЛИМОРФНЫЕ ФОРМЫ 3-(4-АМИНО-1-ОКСО-1,3-ДИГИДРОИЗОИНДОЛ-2-ИЛ)ПИПЕРИДИН-2,6-ДИОНА (POLYMORPHIC FORMS OF 3-(4-AMINO-1-OXO-1,3 DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE)	⤷ Sign Up
South Korea	20050072801	METHODS AND COMPOSITIONS USING IMMUNOMODULATORY COMPOUNDS FOR TREATMENT AND MANAGEMENT OF CANCERS AND OTHER DISEASES	⤷ Sign Up
New Zealand	536907	Methods and compositions using immunomodulatory compounds for treatment and management of cancers and other diseases	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for POMALIDOMIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2105135	1590004-6	Sweden	⤷ Sign Up	PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
2105135	122015000013	Germany	⤷ Sign Up	PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135	00140	Estonia	⤷ Sign Up
2105135	C20150005 00140	Estonia	⤷ Sign Up	PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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