Organon Company Profile

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

ORGANON has fifty-nine approved drugs.

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

There are three hundred and thirteen patent family members on ORGANON drugs in forty-four countries and one hundred and thirty-six supplementary protection certificates in fifteen countries.

Summary for Organon

International Patents:	313
US Patents:	6
Tradenames:	56
Ingredients:	43
NDAs:	59

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	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes	9,757,552		Y
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-003	Oct 20, 2005	AB	RX	Yes	No
Organon Usa Inc	REVERSOL	edrophonium chloride	INJECTABLE;INJECTION	089624-001	May 13, 1988		DISCN	No	No
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013		DISCN	Yes	No
Organon Usa Inc	LIQUAEMIN SODIUM	heparin sodium	INJECTABLE;INJECTION	000552-004	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for Organon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-003	Apr 25, 1997	5,358,941*PED
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000	6,008,207*PED
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409-001	Jul 26, 2002	8,007,830
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	5,595,997*PED
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992	4,900,755
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-002	Sep 29, 1995	6,015,801

Paragraph IV (Patent) Challenges for ORGANON drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	250 mcg/0.5 mL, 1 mL PFS		2012-03-30
	Tablets	10 mg		2007-02-20
	Tablets	5 mg		2006-06-21
	Orally Disintegrating Tablets	5 mg and 10 mg		2006-02-17
	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
	Nasal Spray	50 mcg/ Spray		2009-08-07
	Tablets	5 mg and 10 mg		2004-09-02
	Vaginal Ring	0.015 mg/24 hour and 0.12 mg/24 hour		2013-06-17
	Topical Solution (Lotion)	0.10%		2004-06-10
	Chewable Tablets	4 mg and 5 mg		2006-12-26
	Orally Disintegrating Tablets	2.5 mg and 5 mg		2006-06-21
	Oral Solution	70 mg/75 mL		2007-09-07
	Tablets	100 mg/12.5 mL		2006-04-04
	Tablets	10 mg		2006-10-25
	Tablets	70 mg/2800 IU and 70 mg/5600 IU		2007-11-20

International Patents for Organon Drugs

Country	Patent Number	Estimated Expiration
China	101370550
Slovakia	7702003
Israel	177970
Israel	155771
World Intellectual Property Organization (WIPO)	2017015232
Japan	2008088184

Supplementary Protection Certificates for Organon Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0247633	97C0103	Belgium		PRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
2968172	122021000009	Germany		PRODUCT NAME: CALCIFEDIOL UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE UND HYDRATE DAVON, BEVORZUGT CALCIFEDIOLMONOHYDRAT; REGISTRATION NO/DATE: 2202115.00.00 20200818
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
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
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826

Similar Applicant Names

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

• Organics Lagrange
• Organon
• Organon Llc
• Organon Usa Inc
• Organon Usa Organon