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 Llc, Organon, Anda Repository, Cosette, Fougera Pharms, Glenmark Generics, Taro, Intersect Ent Inc, Encube, Padagis Israel, Padagis Us, Torrent, Amneal, Amneal Pharms, Apotex, Perrigo Pharma Intl, and Glenmark Specialty, and is included in thirty 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-three 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:	17
NDAs:	30
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	23
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
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
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
		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

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
Glenmark Specialty	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes			Y
Cosette	MOMETASONE FUROATE	mometasone furoate	LOTION;TOPICAL	077678-001	Nov 21, 2007	AB	RX	No	No
Fougera Pharms	MOMETASONE FUROATE	mometasone furoate	OINTMENT;TOPICAL	077061-001	Mar 28, 2005	AB	RX	No	No

Expired US Patents for mometasone furoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-001	Mar 30, 2005
Organon Llc	ASMANEX TWISTHALER	mometasone furoate	POWDER;INHALATION	021067-002	Feb 1, 2008
Organon Llc	NASONEX	mometasone furoate	SPRAY, METERED;NASAL	020762-001	Oct 1, 1997

International Patents for mometasone furoate

Country	Patent Number	Title	Estimated Expiration
Canada	3001814	DISPOSITIFS EXPANSIBLES ET PROCEDES POUR LES UTILISER (EXPANDABLE DEVICES AND METHODS THEREFOR)
World Intellectual Property Organization (WIPO)	2006107957
European Patent Office	1871383	DISPOSITIFS ET PROCEDES DE TRAITEMENT DES AFFECTIONS SINUS PARANASAUX (DEVICE AND METHODS FOR TREATING PARANASAL SINUS CONDITIONS)

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
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
3043773	21C1057	France		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