ASMANEX HFA Drug Patent Profile
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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 18th, 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

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 |
Anatomical Therapeutic Chemical (ATC) Classes for ASMANEX HFA
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
NEW STRENGTH
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Organon | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Organon | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-003 | Aug 12, 2019 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 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 | See Plans and Pricing | See Plans and Pricing |
Organon | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | See Plans and Pricing | See Plans and Pricing |
Organon | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | See Plans and Pricing | |
Japan | 2003313128 | USE OF MOMETASONE FUROATE FOR TREATING AIRWAY PASSAGE AND LUNG DISEASE | See Plans and Pricing |
Japan | 2008031184 | USE OF MOMETASONE FUROATE FOR TREATING AIRWAY PASSAGE AND LUNG DISEASE | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ASMANEX HFA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0112669 | 96C0002 | Belgium | See Plans and Pricing | PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622 |
0548114 | SPC/GB97/064 | United Kingdom | See Plans and Pricing | PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |