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	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991	AB	RX	Yes	No
Organon	ELOCON	mometasone furoate	CREAM;TOPICAL	019625-002	Apr 19, 2013		DISCN	Yes	No
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes	11,129,896
Organon Usa Inc	NORCURON	vecuronium bromide	INJECTABLE;INJECTION	018776-002	Apr 30, 1984		DISCN	Yes	No
Organon	CELESTONE SOLUSPAN	betamethasone acetate; betamethasone sodium phosphate	INJECTABLE;INJECTION	014602-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008		RX	Yes	No
Organon Usa Inc	NORCURON	vecuronium bromide	INJECTABLE;INJECTION	018776-003	Jan 3, 1992		DISCN	Yes	No

Expired US Patents for Organon

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	DIPROLENE	betamethasone dipropionate	LOTION, AUGMENTED;TOPICAL	019716-001	Aug 1, 1988	4,775,529
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-002	Jul 23, 2004	RE37721*PED
Organon	LOTRISONE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	018827-001	Jul 10, 1984	3,705,172
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-003	Oct 13, 1998	5,608,075*PED
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014	6,057,307*PED
Organon	PROPECIA	finasteride	TABLET;ORAL	020788-001	Dec 19, 1997	5,571,817
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-002	Jul 23, 2004	RE42461*PED

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
	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
	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

International Patents for Organon Drugs

Country	Patent Number	Estimated Expiration
Japan	2009286801
Australia	2002247019
Spain	2308460
Slovenia	1413331
Hungary	E052622
Brazil	PI0706472
Brazil	0206654

Supplementary Protection Certificates for Organon Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0613371	2002C/022	Belgium		PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
0480717	9890027-7	Sweden		PRODUCT NAME: MONTELUKAST, R-(E)-1-1-3-2-(7-KLOR-2KINOLINYL)-ETENYL)-FENYL)-3-(2-(1-HYDROXI-1-METYLETYL)-FENYL)-PROPYL)-TIO)METYL)-CYKLOPROPANAETTIKSYRA, ELLER ETT FARMACEUTISKT GODDTAGBART SALT DAERAV, FOERETRAEDESVIS NATRIUMSALTET; NAT REG./DATE: 13944 19880111; FIRST REG.: FI EG 12766 19970825
2435025	CA 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
0277829	C300016	Netherlands		PRODUCT NAME: GANIRELIX, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517
0480717	19/1999	Austria		PRODUCT NAME: MONTELUKAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MONTELUKASTNATRIUM; NAT. REGISTRATION NO/DATE: 1-22765 UND 1-22766 19981030; FIRST REGISTRATION: FI 12766 UND 12767 19970825
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220

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