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-two 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:	32
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	141
Patent Applications:	6,223
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
Morten Hostrup, PhD	N/A
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	Phase 2
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4

See all mometasone furoate clinical trials

Generic filers with tentative approvals for MOMETASONE FUROATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Encube	MOMETASONE FUROATE	mometasone furoate	OINTMENT;TOPICAL	076481-001	Nov 14, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	MOMETASONE FUROATE	mometasone furoate	OINTMENT;TOPICAL	077401-001	Jun 20, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	⤷ Sign Up	⤷ Sign Up
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014	⤷ Sign Up	⤷ Sign Up
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	⤷ Sign Up	⤷ Sign Up
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014	⤷ Sign Up	⤷ Sign Up
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008	⤷ Sign Up	⤷ Sign Up
>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
China	101189016	Device and methods for treating paranasal sinus conditions	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2010014834		⤷ Sign Up
Australia	2009276505	Methods and devices for crimping self-expanding devices	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004082525		⤷ Sign Up
European Patent Office	2968877	SYSTÈMES ET DISPOSITIFS DE TRAITEMENT D'UNE AFFECTION SINUSALE (SYSTEMS AND DEVICES FOR TREATING A SINUS CONDITION)	⤷ Sign Up
>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
0548114	SPC/GB97/064	United Kingdom	⤷ Sign Up	PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
3043773	21C1057	France	⤷ Sign Up	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
3043773	2190041-0	Sweden	⤷ Sign Up	PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
0112669	96C0002	Belgium	⤷ Sign Up	PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
3043773	2022C/520	Belgium	⤷ Sign Up	PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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