ASMANEX HFA Drug Patent Profile

Which patents cover Asmanex Hfa, and what generic alternatives are available?

Asmanex Hfa is a drug marketed by Organon and is included in one NDA.

The generic ingredient in ASMANEX HFA is mometasone furoate. There are thirty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Asmanex Hfa

A generic version of ASMANEX HFA was approved as mometasone furoate by PADAGIS US on March 18^th, 2002.

Summary for ASMANEX HFA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	12
Patent Applications:	5,813
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ASMANEX HFA
Drug Sales Revenues:	Drug sales revenues for ASMANEX HFA
What excipients (inactive ingredients) are in ASMANEX HFA?	ASMANEX HFA excipients list
DailyMed Link:	ASMANEX HFA at DailyMed

See drug prices for ASMANEX HFA

See drug sales revenues for ASMANEX HFA

Recent Clinical Trials for ASMANEX HFA

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
Milton S. Hershey Medical Center	Phase 3
University of Dundee	Phase 4

See all ASMANEX HFA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ASMANEX HFA

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

US Patents and Regulatory Information for ASMANEX HFA

ASMANEX HFA is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting ASMANEX HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-003	Aug 12, 2019		RX	Yes	No
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014		RX	Yes	Yes
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-003	Aug 12, 2019		RX	Yes	No

Expired US Patents for ASMANEX HFA

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 HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014

International Patents for ASMANEX HFA

See the table below for patents covering ASMANEX HFA around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	962828
Japan	2003313128	USE OF MOMETASONE FUROATE FOR TREATING AIRWAY PASSAGE AND LUNG DISEASE
Japan	2008031184	USE OF MOMETASONE FUROATE FOR TREATING AIRWAY PASSAGE AND LUNG DISEASE

Supplementary Protection Certificates for ASMANEX HFA

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