ORGANON Company Profile

What is the competitive landscape for ORGANON, and when can generic versions of ORGANON drugs launch?

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 Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-002	Jul 23, 2004	AB	RX	Yes	No
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992		DISCN	Yes	No
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995		DISCN	Yes	No
Organon Usa Inc	LIQUAEMIN SODIUM PRESERVATIVE FREE	heparin sodium	INJECTABLE;INJECTION	000552-012	Apr 11, 1986		DISCN	No	No

Expired US Patents for ORGANON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	7,214,684*PED
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000	5,849,726*PED
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995	5,608,075
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-001	Jun 29, 1998	5,602,162*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,210,079*PED

Paragraph IV (Patent) Challenges for ORGANON drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for ORGANON Drugs

Country	Patent Number	Estimated Expiration
Hong Kong	1115073
Taiwan	200840563
Brazil	0212907
European Patent Office	1841492
Mexico	PA03006724

Supplementary Protection Certificates for ORGANON Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	98C0022	France		PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
0720599	03C0028	France		PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
2435025	PA2019014	Lithuania		PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218

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