Mometasone furoate - Generic Drug Details

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, Merck Sharp Dohme, Anda Repository, Cosette, Fougera Pharms, Glenmark Generics, Taro, Intersect Ent Inc, Padagis Israel, Padagis Us, Torrent, Amneal Pharms, Apotex Inc, Perrigo Pharma Intl, and Glenmark Specialty, and is included in twenty-nine NDAs. There are twenty-five 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. Eighteen suppliers are listed for this compound.

Summary for mometasone furoate

International Patents:	47
US Patents:	25
Tradenames:	8
Applicants:	15
NDAs:	29
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	133
Patent Applications:	8,109
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
Pi Research Consultancy Center, Bangladesh	Early Phase 1
Hvidovre University Hospital	Phase 4
Xijing Hospital	N/A

See all mometasone furoate clinical trials

Pharmacology for mometasone furoate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for mometasone furoate

Anti-Allergic Agents

Anti-Inflammatory Agents

Dermatologic Agents

Anatomical Therapeutic Chemical (ATC) Classes for mometasone furoate

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 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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Anda Repository	MOMETASONE FUROATE	mometasone furoate	CREAM;TOPICAL	076591-001	Apr 18, 2007		DISCN	No	No
Taro	MOMETASONE FUROATE	mometasone furoate	CREAM;TOPICAL	076679-001	Dec 21, 2004	AB	RX	No	No
Fougera Pharms	MOMETASONE FUROATE	mometasone furoate	LOTION;TOPICAL	075919-001	Nov 29, 2007	AB	RX	No	No
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No

Expired US Patents for mometasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014
Organon	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008
Organon	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008
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	Title	Estimated Expiration
China	106039547	可展开装置及其使用方法 (Expandable devices and methods therefor)
Japan	6757761
Japan	2016512129	副鼻腔状態を処置するためのシステム、デバイスおよび方法
Canada	2761769	DISPOSITIFS EXPANSIBLES ET PROCEDES POUR LES UTILISER (EXPANDABLE DEVICES AND METHODS THEREFOR)
World Intellectual Property Organization (WIPO)	2010132648

Supplementary Protection Certificates for mometasone furoate

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