ORGANON Company Profile

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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.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Organon Usa Inc	NORCURON	vecuronium bromide	INJECTABLE;INJECTION	018776-003	Jan 3, 1992		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes	8,722,037	⤷ Sign Up	Y			⤷ Sign Up
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-001	Jun 29, 1998		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Organon Usa Inc	DOCA	desoxycorticosterone acetate	INJECTABLE;INJECTION	001104-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004	4,444,784	⤷ Sign Up
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005	4,659,716*PED	⤷ Sign Up
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995	5,681,590*PED	⤷ Sign Up
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	5,977,099	⤷ Sign Up
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	Jun 29, 1998	4,758,598	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	10 mg	➤ Subscribe	2007-02-20
➤ Subscribe	Tablets	5 mg	➤ Subscribe	2006-06-21
➤ Subscribe	Orally Disintegrating Tablets	5 mg and 10 mg	➤ Subscribe	2006-02-17
➤ Subscribe	Tablets	50 mg/12.5 mg and 100 mg/25 mg	➤ Subscribe	2004-05-24
➤ Subscribe	Tablets	10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg	➤ Subscribe	2009-07-27
➤ Subscribe	Nasal Spray	50 mcg/ Spray	➤ Subscribe	2009-08-07
➤ Subscribe	Tablets	5 mg and 10 mg	➤ Subscribe	2004-09-02
➤ Subscribe	Vaginal Ring	0.015 mg/24 hour and 0.12 mg/24 hour	➤ Subscribe	2013-06-17
➤ Subscribe	Topical Solution (Lotion)	0.10%	➤ Subscribe	2004-06-10
➤ Subscribe	Chewable Tablets	4 mg and 5 mg	➤ Subscribe	2006-12-26
➤ Subscribe	Orally Disintegrating Tablets	2.5 mg and 5 mg	➤ Subscribe	2006-06-21
➤ Subscribe	Oral Solution	70 mg/75 mL	➤ Subscribe	2007-09-07
➤ Subscribe	Tablets	100 mg/12.5 mL	➤ Subscribe	2006-04-04
➤ Subscribe	Tablets	10 mg	➤ Subscribe	2006-10-25
➤ Subscribe	Tablets	70 mg/2800 IU and 70 mg/5600 IU	➤ Subscribe	2007-11-20
➤ Subscribe	Injection	250 mcg/0.5 mL, 1 mL PFS	➤ Subscribe	2012-03-30

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0497512	99C0011	Belgium	⤷ Sign Up	PRODUCT NAME: RIZATRIPTAN BENZOAS EQ. RIZATRIPTAN; REGISTRATION NO/DATE: 922 IS 181 F 3 19981130; FIRST REGISTRATION: NL RVG 21815 19980211
2435025	36/2019	Austria	⤷ Sign Up	PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
0277829	2000C/030	Belgium	⤷ Sign Up	PRODUCT NAME: GANIRELIX; REGISTRATION NO/DATE: EU/1/00/130/001 20000518
1453521	300814	Netherlands	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0720599	122014000088	Germany	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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