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Celgene Company Profile

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What is the competitive landscape for CELGENE, and what generic alternatives to CELGENE drugs are available?

CELGENE has seven approved drugs.

There are forty-seven US patents protecting CELGENE drugs.

There are six hundred and fifty-three patent family members on CELGENE drugs in fifty-one countries and twenty supplementary protection certificates in twelve countries.

Summary for Celgene

International Patents:	653
US Patents:	47
Tradenames:	7
Ingredients:	7
NDAs:	7
Patent Litigation for Celgene:	See patent lawsuits for Celgene
PTAB Cases with Celgene as patent owner:	See PTAB cases with Celgene as patent owner

Drugs and US Patents for Celgene

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	204026-004	Feb 8, 2013		RX	Yes	Yes	6,045,501
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013		RX	Yes	No	8,626,531
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-004	Jun 29, 2006		RX	Yes	Yes	7,468,363
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-002	Dec 27, 2005		RX	Yes	No	7,468,363

Expired US Patents for Celgene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-004	Jan 10, 2007	8,143,283
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-001	Feb 8, 2013	8,158,653
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-004	Jun 29, 2006	8,288,415
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-002	Feb 8, 2013	5,635,517

Paragraph IV (Patent) Challenges for CELGENE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	50 mg and 100 mg		2006-12-18
	Capsules	25 mg		2010-07-12
	Injection	10 mg/vial		2013-11-05
	Capsules	2.5 mg and 20 mg		2016-07-12
	Tablets	10 mg, 20 mg and30 mg		2018-03-22
	Capsules	200 mg		2006-09-25
	Capsules	5 mg, 10 mg and 15 mg		2010-08-30
	Capsules	150 mg		2014-02-03
	Capsules	1 mg, 2 mg, 3 mg and 4 mg		2017-02-08

Non-Orange Book US Patents for Celgene

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,335,349	Substituted 2(2,6-dioxopiperidin-3-yl)isoindolines
9,371,361	Method of producing FR901228
8,188,118	Method for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with antibodies
8,198,306	Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with a proteasome inhibitor

International Patents for Celgene Drugs

Country	Document Number	Estimated Expiration
European Patent Office	2177517
European Patent Office	1505973
Russian Federation	2406501
Spain	2331991

Supplementary Protection Certificates for Celgene Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0925294/01	Switzerland		PRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
C0056	France		PRODUCT NAME: LENALIDOMIDE; REGISTRATION NO/DATE: EU/1/07/391/001-004 20070614
359	Luxembourg		91359, EXPIRES: 20220614
2 50002-2015	Slovakia		PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Celgene
• Celgene Corp