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Last Updated: May 10, 2024

MOMETASONE FUROATE - Generic Drug Details

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What are the generic sources for mometasone furoate and what is the scope of patent protection?

Mometasone furoate is the generic ingredient in eight branded drugs marketed by Organon Llc, Organon, Anda Repository, Cosette, Fougera Pharms, Glenmark Pharms Inc, Taro, Intersect Ent Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, Padagis Us, Torrent, Amneal, Amneal Pharms, Apotex, Aurobindo Pharma, Perrigo Pharma Intl, and Glenmark Specialty, and is included in thirty-one NDAs. There are twenty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mometasone furoate has forty-seven patent family members in twelve countries.

There are twenty-seven drug master file entries for mometasone furoate. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for MOMETASONE FUROATE

International Patents:	47
US Patents:	27
Tradenames:	8
Applicants:	19
NDAs:	31
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	140
Patent Applications:	7,358
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for MOMETASONE FUROATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOMETASONE FUROATE
What excipients (inactive ingredients) are in MOMETASONE FUROATE?	MOMETASONE FUROATE excipients list
DailyMed Link:	MOMETASONE FUROATE at DailyMed

See drug prices for MOMETASONE FUROATE

Drug Sales Revenue Trends for MOMETASONE FUROATE

See drug sales revenues for MOMETASONE FUROATE

Recent Clinical Trials for MOMETASONE FUROATE

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

Sponsor	Phase
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	Phase 2
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4
Sandoz	Phase 1

See all MOMETASONE FUROATE clinical trials

Generic filers with tentative approvals for MOMETASONE FUROATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	0.05MG/SPRAY	SPRAY, METERED;NASAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for MOMETASONE FUROATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for MOMETASONE FUROATE

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Paragraph IV (Patent) Challenges for MOMETASONE FUROATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NASONEX	Nasal Spray	mometasone furoate	50 mcg/ Spray	020762	1	2009-08-07
ELOCON	Topical Solution (Lotion)	mometasone furoate	0.1%	019796	1	2004-06-10

US Patents and Regulatory Information for MOMETASONE FUROATE

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Glossary

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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
Perrigo Pharma Intl	NASONEX 24HR ALLERGY	mometasone furoate	SPRAY, METERED;NASAL	215712-001	Mar 17, 2022		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Organon	ELOCON	mometasone furoate	OINTMENT;TOPICAL	019543-001	Apr 30, 1987		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	MOMETASONE FUROATE	mometasone furoate	SPRAY, METERED;NASAL	091161-001	Mar 22, 2016	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for MOMETASONE FUROATE

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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	⤷ Try a Trial	⤷ Try a Trial
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	⤷ Try a Trial	⤷ Try a Trial
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	⤷ Try a Trial	⤷ Try a Trial
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for MOMETASONE FUROATE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2429624	Combinaison d'un dispositif expansible et dispositif de mise en place (A combination of an expandable device and a delivery device.)	⤷ Try a Trial
Mexico	2007012324	DISPOSITIVO Y METODO PARA TRATAR CONDICIONES DEL SENO PARANASAL. (DEVICE AND METHODS FOR TREATING PARANASAL SINUS CONDITIONS.)	⤷ Try a Trial
Australia	2019201045	Systems, devices, and method for treating a sinus condition	⤷ Try a Trial
Japan	2008537695		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MOMETASONE FUROATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	132021000000191	Italy	⤷ Try a Trial	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
0548114	SPC/GB97/064	United Kingdom	⤷ Try a Trial	PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
3043773	2022C/520	Belgium	⤷ Try a Trial	PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0112669	96C0002	Belgium	⤷ Try a Trial	PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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