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 Usa Inc	MAXIBOLIN	ethylestrenol	TABLET;ORAL	014005-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-002	Sep 29, 1995		DISCN	Yes	No
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-002	Jan 12, 2001	AB	RX	Yes	No
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	AB	RX	Yes	No
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002		DISCN	Yes	No
Organon	NEXPLANON	etonogestrel	IMPLANT;IMPLANTATION	021529-002	May 13, 2011		RX	Yes	Yes	8,722,037		Y

Expired US Patents for ORGANON

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
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-004	Oct 20, 2000	5,849,726*PED
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995	5,608,075
Organon Llc	MAXALT	rizatriptan benzoate	TABLET;ORAL	020864-001	Jun 29, 1998	5,602,162*PED
Organon	COZAAR	losartan potassium	TABLET;ORAL	020386-001	Apr 14, 1995	5,210,079*PED
Organon	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-001	Jun 29, 1998	4,305,502

Paragraph IV (Patent) Challenges for ORGANON drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for ORGANON Drugs

Country	Patent Number	Estimated Expiration
Hong Kong	1056696
Norway	338191
Latvia	13521
China	1953770
European Patent Office	1353696
European Patent Office	1363668

Supplementary Protection Certificates for ORGANON Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2021019	Norway		PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216
2435024	15/2021	Austria		PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435024	C02435024/01	Switzerland		PRODUCT NAME: BUDESONID, GLYCOPYRRONIUM UND FORMOTEROL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68388 24.11.2021
0152897	2001C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
2435025	2019026	Norway		PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104
2435024	C202130025	Spain		PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209

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