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Organon Company Profile

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

ORGANON has thirty-three approved drugs.

There are eight US patents protecting ORGANON drugs. There is one tentative approval on ORGANON drugs.

There are three hundred and forty-five patent family members on ORGANON drugs in forty-six countries and seventy-eight supplementary protection certificates in eleven countries.

Summary for Organon

International Patents:	345
US Patents:	8
Tradenames:	36
Ingredients:	31
NDAs:	33
Patent Litigation for Organon:	See patent lawsuits for Organon

Drugs and US Patents for Organon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-003	Mar 17, 1994		DISCN	Yes	No
Organon Usa Inc	LIQUAEMIN LOCK FLUSH	heparin sodium	INJECTABLE;INJECTION	000552-007	Approved Prior to Jan 1, 1982		DISCN	No	No
Organon Usa Inc	LIQUAEMIN SODIUM PRESERVATIVE FREE	heparin sodium	INJECTABLE;INJECTION	000552-013	Apr 11, 1986		DISCN	No	No
Organon Usa Inc	DOCA	desoxycorticosterone acetate	INJECTABLE;INJECTION	001104-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Organon Usa Inc	METHYLPREDNISOLONE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	087535-002	Jun 25, 1982		DISCN	No	No

Expired US Patents for Organon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-005	Jul 10, 1998	RE36481*PED
Organon Usa Inc	IMPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-001	Jul 17, 2006	4,957,119
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,608,075*PED
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-004	Jul 23, 2004	RE42461*PED
Organon Usa Inc	PAVULON	pancuronium bromide	INJECTABLE;INJECTION	017015-001	Approved Prior to Jan 1, 1982	3,553,212

Paragraph IV (Patent) Challenges for ORGANON drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	50 mg/12.5 mg and 100 mg/25 mg		2004-05-24
	Tablets	10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg		2009-07-27
	Vaginal Ring	0.015 mg/24 hour and 0.12 mg/24 hour		2013-06-17
	Nasal Spray	50 mcg/ Spray		2009-08-07
	Tablets	100 mg/12.5 mL		2006-04-04
	Tablets	10 mg		2006-10-25
	Injection	250 mcg/0.5 mL, 1 mL PFS		2012-03-30

International Patents for Organon Drugs

Country	Patent Number	Estimated Expiration
Norway	20033357
Canada	2434436
Czech Republic	20031674
Poland	364178
South Africa	200203538

Supplementary Protection Certificates for Organon Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	122014000088	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
1259550	C01259550/01	Switzerland		FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL
0720599	C300132	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION: RVG 28626 20030418; FIRST REGISTRATION: DE 54486.00.00, 54487.00.00, 54488.00.00, 54489.00.00 20021017
1259550	SPC/GB08/057	United Kingdom		PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725

Similar Applicant Names

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

• Organics Lagrange
• Organon
• Organon Sub Merck
• Organon Usa Inc