NASONEX Drug Patent Profile

Which patents cover Nasonex, and what generic alternatives are available?

Nasonex is a drug marketed by Organon Llc and Perrigo Pharma Intl and is included in two NDAs.

The generic ingredient in NASONEX is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nasonex

A generic version of NASONEX was approved as mometasone furoate by PADAGIS US on March 18^th, 2002.

Summary for NASONEX

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	60
Patent Applications:	4,548
Drug Prices:	Drug price information for NASONEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NASONEX
What excipients (inactive ingredients) are in NASONEX?	NASONEX excipients list
DailyMed Link:	NASONEX at DailyMed

See drug prices for NASONEX

See drug sales revenues for NASONEX

Recent Clinical Trials for NASONEX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yingu Pharmaceutical Co., Ltd	Phase 4
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4
EMS	Phase 3

See all NASONEX clinical trials

Paragraph IV (Patent) Challenges for NASONEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NASONEX	Nasal Spray	mometasone furoate	50 mcg/ Spray	020762	1	2009-08-07

US Patents and Regulatory Information for NASONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997		DISCN	Yes	No
Perrigo Pharma Intl	NASONEX 24HR ALLERGY	mometasone furoate	SPRAY, METERED;NASAL	215712-001	Mar 17, 2022		OTC	Yes	Yes

Expired US Patents for NASONEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997

International Patents for NASONEX

See the table below for patents covering NASONEX around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2091360	FUORATE DE MOMETASONE MONOHYDRATE, SON PROCEDE DE FABRICATION ET SES COMPOSITIONS PHARMACEUTIQUES (MOMETASONE FUROATE MONOHYDRATE, PROCESS FOR MAKING SAME AND PHARMACEUTICAL COMPOSITIONS)
Spain	2173947
Hungary	9300685
Czech Republic	9300383
Hong Kong	68487	AROMATIC HETEROCYCLIC ESTERS OF STEROIDS,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM

Supplementary Protection Certificates for NASONEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	21C1057	France		PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
0548114	C980012	Netherlands		PRODUCT NAME: MOMETASONI FUROAS MONOHYDRATUM; NAT. REGISTRATION NO/DATE: RVG 21613 19971209; FIRST REGISTRATION: FR NL22055 19970219
0548114	5/1998	Austria		PRODUCT NAME: MOMETASON FUROAT MONOHYDRAT; NAT. REGISTRATION NO/DATE: 1-22208 19971111; FIRST REGISTRATION: FR AMM 343012.6 19970219
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410