Organon Company Profile

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ORGANON has fifty-nine approved drugs.

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

There are four hundred and twenty-five patent family members on ORGANON drugs in forty-nine countries and one hundred and thirty-six supplementary protection certificates in sixteen 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	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998	AB	RX	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Organon	PROSCAR	finasteride	TABLET;ORAL	020180-001	Jun 19, 1992	AB	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Organon Usa Inc	LYNORAL	ethinyl estradiol	TABLET;ORAL	005490-002	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Organon	CELESTONE SOLUSPAN	betamethasone acetate; betamethasone sodium phosphate	INJECTABLE;INJECTION	014602-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Organon	DIPROLENE	betamethasone dipropionate	LOTION, AUGMENTED;TOPICAL	019716-001	Aug 1, 1988		DISCN	Yes	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	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	5,686,104*PED	⤷ Try a Trial
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	5,687,710*PED	⤷ Try a Trial
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013	RE42461*PED	⤷ Try a Trial
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,210,079*PED	⤷ Try a Trial
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	Approved Prior to Jan 1, 1982	RE29892	⤷ Try a Trial
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004	RE42461*PED	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Country	Patent Number	Estimated Expiration
Hungary	227451	⤷ Try a Trial
Russian Federation	2007132008	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006077242	⤷ Try a Trial
Israel	156585	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	02058685	⤷ Try a Trial
Czech Republic	20032031	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0152897	2001C/013	Belgium	⤷ Try a Trial	PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
1003503	05C0048	France	⤷ Try a Trial	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
0720599	05C0040	France	⤷ Try a Trial	PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
2481400	C02481400/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: CALCIFEDIOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67614 22.12.2020
0277829	C300016	Netherlands	⤷ Try a Trial	PRODUCT NAME: GANIRELIX, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517
0277829	27/2000	Austria	⤷ Try a Trial	PRODUCT NAME: GANIRELIX ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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