Organon Company Profile

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

ORGANON has forty-three approved drugs.

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

There are three hundred and seventy-one patent family members on ORGANON drugs in forty-six countries and one hundred and twenty-three supplementary protection certificates in sixteen countries.

Summary for Organon

International Patents:	371
US Patents:	8
Tradenames:	46
Ingredients:	38
NDAs:	43

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	PAVULON	pancuronium bromide	INJECTABLE;INJECTION	017015-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	AB	RX	Yes	No
Organon Usa Inc	LYNORAL	ethinyl estradiol	TABLET;ORAL	005490-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991	AB	RX	Yes	No

Expired US Patents for Organon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-004	Jul 23, 2004	4,444,784
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-005	Jul 10, 1998	4,444,784*PED
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	7,265,099
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015	7,265,009
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-001	Jul 23, 2004	5,846,966*PED

Paragraph IV (Patent) Challenges for ORGANON drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	10 mg		2006-10-25
	Injection	250 mcg/0.5 mL, 1 mL PFS		2012-03-30
	Tablets	10 mg		2007-02-20
	Nasal Spray	50 mcg/ Spray		2009-08-07
	Orally Disintegrating Tablets	2.5 mg and 5 mg		2006-06-21
	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
	Chewable Tablets	4 mg and 5 mg		2006-12-26
	Tablets	5 mg		2006-06-21
	Tablets	70 mg/2800 IU and 70 mg/5600 IU		2007-11-20
	Tablets	100 mg/12.5 mL		2006-04-04

International Patents for Organon Drugs

Country	Patent Number	Estimated Expiration
Czech Republic	20032030
Israel	184586
European Patent Office	3417905
World Intellectual Property Organization (WIPO)	02058733
Slovakia	286282

Supplementary Protection Certificates for Organon Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	300689	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
1003503	05C0048	France		PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
0720599	C300172	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402

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