Organon Company Profile

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ORGANON has fifty-eight 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-seven supplementary protection certificates in fifteen countries.

International Patents:	313
US Patents:	6
Tradenames:	52
Ingredients:	42
NDAs:	58
Patent Litigation for Organon:	See patent lawsuits for Organon

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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	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	020864-002	Jun 29, 1998	AB	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-003	Mar 17, 1997		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Organon Usa Inc	PAVULON	pancuronium bromide	INJECTABLE;INJECTION	017015-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-002	Jun 14, 1996	AB	RX	Yes	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	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-005	Oct 20, 2000	5,994,329*PED	⤷ Sign Up
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-002	Jun 29, 1998	4,371,516	⤷ Sign Up
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	7,030,106*PED	⤷ Sign Up
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005	8,173,172*PED	⤷ Sign Up
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004	RE42461*PED	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	C02435024/01	Switzerland	⤷ Sign Up	PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
0277829	2000C/030	Belgium	⤷ Sign Up	PRODUCT NAME: GANIRELIX; REGISTRATION NO/DATE: EU/1/00/130/001 20000518
1453521	39/2015	Austria	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2968172	SPC/GB20/043	United Kingdom	⤷ Sign Up	PRODUCT NAME: CALCIFEDIOL, AND/OR A SALT OR HYDRATE THEREOF, IN PARTICULAR CALCIFEDIOL MONOHYDRATE; REGISTERED: UK PL 50784/0005-0001 20200721
0720599	26/2005	Austria	⤷ Sign Up	PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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