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	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-002	Jun 29, 1998	AB	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Organon Usa Inc	LIQUAEMIN SODIUM	heparin sodium	INJECTABLE;INJECTION	000552-004	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Organon	ELOCON	mometasone furoate	LOTION;TOPICAL	019796-001	Mar 30, 1989		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Organon Usa Inc	RAPLON	rapacuronium bromide	INJECTABLE;INJECTION	020984-002	Aug 18, 1999		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
>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 Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	7,214,684*PED	⤷ Try a Trial
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000	5,849,726*PED	⤷ Try a Trial
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995	5,608,075	⤷ Try a Trial
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-001	Jun 29, 1998	5,602,162*PED	⤷ Try a Trial
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,210,079*PED	⤷ Try a Trial
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	Jun 29, 1998	4,305,502	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	C300132	Netherlands	⤷ Try a Trial	PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION: RVG 28626 20030418; FIRST REGISTRATION: DE 54486.00.00, 54487.00.00, 54488.00.00, 54489.00.00 20021017
0443983	C00443983/03	Switzerland	⤷ Try a Trial	PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0253310	96C0020	Belgium	⤷ Try a Trial	PRODUCT NAME: KALII LOSARTAN; NAT. REGISTRATION NO/DATE: 922 IS 169 F3 19960130; FIRST REGISTRATION: SE 12209 19940902
1175904	2007C/048	Belgium	⤷ Try a Trial	PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
0287150	96C0038	Belgium	⤷ Try a Trial	PRODUCT NAME: ROCURONIUMBROMIDE; NAT. REGISTRATION NO/DATE: 63 IS 9 F 12 19960709; FIRST REGISTRATION: NL RVG 16946 19940406
2435025	PA2019014,C2435025	Lithuania	⤷ Try a Trial	PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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