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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 fifty US patents protecting CELGENE drugs.

Summary for Celgene

US Patents:	50
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	204026-002	Feb 8, 2013		RX	Yes	No	8,198,262
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-005	Dec 21, 2011		RX	Yes	No
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013		RX	Yes	No	6,908,432
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006		RX	Yes	No
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013		RX	Yes	No	7,855,217		Y	Y
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-006	Jun 5, 2013		RX	Yes	No	8,648,095
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-003	Jun 29, 2006		RX	Yes	No	7,189,740

Expired US Patents for Celgene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-001	Jul 16, 1998	8,204,763
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-004	Jun 29, 2006	8,204,763
Celgene	THALOMID	thalidomide	CAPSULE;ORAL	020785-002	Jan 17, 2003	7,874,984
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-001	Dec 27, 2005	8,204,763
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-002	Dec 27, 2005	7,119,106
Celgene	POMALYST	pomalidomide	CAPSULE;ORAL	204026-003	Feb 8, 2013	6,908,432
Celgene	REVLIMID	lenalidomide	CAPSULE;ORAL	021880-005	Dec 21, 2011	6,908,432

Paragraph IV (Patent) Challenges for CELGENE drugs

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

International Patents for Celgene Drugs

Country	Document Number	Estimated Expiration
Australia	2013207289
Hong Kong	1092388
Japan	2009215310
Czech Republic	9904278
European Patent Office	2087891
Australia	2008207659
New Zealand	564480

Supplementary Protection Certificates for Celgene Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0036	France		PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
C/GB07/047	United Kingdom		PRODUCT NAME: LENALIDOMIDE (COMMON NAME) 1-OXO-2-(2,6-DIOXOPIPERIDIN-3-YL)-4-AMINOSOINDOLINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/07/391/001 20070619; UK EU/1/07/391/002 20070619; UK EU/1/07/391/003 20070619; UK EU/1/07/391/004 20070619
0717	Netherlands		PRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2015 00006	Denmark		PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
2007 00054	Denmark		PRODUCT NAME: LENALIDOMID, EVT. I FORM AF SYREADDITIONSSALT
90004-6	Sweden		PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
2015	Austria		PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE; REGISTRATION NO/DATE: EU/1/13/850 20130805

Similar Applicant Names

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

• Celgene
• Celgene Corp