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 Usa Organon	NUVARING	ethinyl estradiol; etonogestrel	RING;VAGINAL	021187-001	Oct 3, 2001	AB	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	AB	RX	Yes	Yes	7,612,058*PED	⤷ Sign Up			Y	⤷ Sign Up
Organon	ELOCON	mometasone furoate	CREAM;TOPICAL	019625-001	May 6, 1987		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	MAXALT-MLT	rizatriptan benzoate	TABLET, ORALLY DISINTEGRATING;ORAL	020865-002	Jun 29, 1998	5,457,895*PED	⤷ Sign Up
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-001	May 30, 1991	4,900,755	⤷ Sign Up
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	6,057,307*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	132021000000095	Italy	⤷ Sign Up	PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
1304992	PA2013025,C1304992	Lithuania	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
0613371	SPC/GB02/033	United Kingdom	⤷ Sign Up	PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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