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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 six branded drugs marketed by Organon, Merck Sharp Dohme, Anda Repository, Cosette, Fougera Pharms, Glenmark Generics, Taro, Intersect Ent Inc, Padagis Israel, Padagis Us, Torrent, Amneal Pharms, and Apotex Inc, and is included in twenty-seven NDAs. There are thirteen 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 thirty drug master file entries for mometasone furoate. Twenty-one suppliers are listed for this compound.

Summary for mometasone furoate

International Patents:	47
US Patents:	13
Tradenames:	6
Applicants:	13
NDAs:	27
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	112
Patent Applications:	7,207
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for mometasone furoate
Drug Sales Revenues:	Drug sales revenues 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

See drug sales revenues for mometasone furoate

Recent Clinical Trials for mometasone furoate

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

Sponsor	Phase
EMS	Phase 3
Yingu Pharmaceutical Co., Ltd	Phase 4
Suzhou Connect Biopharmaceuticals, Ltd.	Phase 2

See all mometasone furoate clinical trials

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	NDA	Submissiondate
NASONEX	SPRAY, METERED;NASAL	mometasone furoate	020762	2009-08-07
ELOCON	LOTION;TOPICAL	mometasone furoate	019796	2004-06-10
ELOCON	CREAM;TOPICAL	mometasone furoate	019625

US Patents and Regulatory Information for mometasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No			Y
Organon	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008		RX	Yes	No
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No
Anda Repository	MOMETASONE FUROATE	mometasone furoate	CREAM;TOPICAL	076591-001	Apr 18, 2007		DISCN	No	No
Glenmark Generics	MOMETASONE FUROATE	mometasone furoate	CREAM;TOPICAL	078541-001	May 28, 2008	AB	RX	No	Yes

Expired US Patents for mometasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014
Organon	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005
Organon	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008
Organon	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008

International Patents for mometasone furoate

Country	Patent Number	Estimated Expiration
Japan	6399663
Australia	2006231506
Russian Federation	2007140909
European Patent Office	3636227
European Patent Office	2298317

Supplementary Protection Certificates for mometasone furoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410