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. Sixteen 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:	5,176
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NASONEX
Drug Sales Revenues:	Drug sales revenues 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

Anatomical Therapeutic Chemical (ATC) Classes for NASONEX

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XC	Corticosteroids, potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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
New Zealand	199600	17-(HETEROCYCLIC CARBOXYLATE)-SUBSTITUTED STEROIDS
Norway	820263
European Patent Office	0740550	UTILISATION DU FUROATE DE MOMETASONE POUR LE TRAITEMENT DES AFFECTIONS PULMONAIRES ET DES VOIES RESPIRATOIRES (USE OF MOMETASONE FUROATE FOR TREATING AIRWAY PASSAGE AND LUNG DISEASES)
Denmark	0740550
Bulgaria	60755

Supplementary Protection Certificates for NASONEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773	132021000000191	Italy		PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426
0057401	94C0004	Belgium		PRODUCT NAME: MOMETASONI FUROAS; NAT REG.: 304 S 133 F 7 19930813; FIRST REG.: GR 10682/89 19900622