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 Breckenridge, Eugia Pharma, Mylan, Teva Pharms Usa, and Celgene, and is included in five NDAs. There are six 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-six 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:	356
US Patents:	6
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	242
Patent Applications:	7,466
Formulation / Manufacturing:	see details
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
Maarten Seefat	Phase 4
Institute of Hematology & Blood Diseases Hospital	Phase 1
Rajshekhar Chakraborty, MD	Phase 1/Phase 2

See all pomalidomide clinical trials

Generic filers with tentative approvals for POMALIDOMIDE

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	4MG	CAPSULE;ORAL
See Plans and Pricing	See Plans and Pricing	3MG	CAPSULE;ORAL
See Plans and Pricing	See Plans and Pricing	2MG	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

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
Teva Pharms Usa	POMALIDOMIDE	pomalidomide	CAPSULE;ORAL	209956-002	May 4, 2022	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	AB	RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-004	Feb 8, 2013	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing			Y	See Plans and Pricing
>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
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	See Plans and Pricing	See Plans and Pricing
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	See Plans and Pricing	See Plans and Pricing
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	See Plans and Pricing	See Plans and Pricing
>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	yes	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
Taiwan	I492748		See Plans and Pricing
Denmark	2391355		See Plans and Pricing
Russian Federation	2011134499	КОМПОЗИЦИЯ 4-АМИНО-2-(2,6-ДИОКСОПИПЕРИДИН-3-ИЛ)ИЗОИНДОЛИН-1,3-ДИОНА	See Plans and Pricing
>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	212 50002-2015	Slovakia	See Plans and Pricing	PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
2105135	C300717	Netherlands	See Plans and Pricing	PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2105135	C20150005 00140	Estonia	See Plans and Pricing	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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