ASMANEX HFA Drug Patent Profile
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When do Asmanex Hfa patents expire, and what generic alternatives are available?
Asmanex Hfa is a drug marketed by Organon Llc 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. Twenty-three 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 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 79 |
Clinical Trials: | 12 |
Patent Applications: | 5,430 |
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 |
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 |
Teva Pharmaceuticals USA | Phase 4 |
Pharmacology for ASMANEX HFA
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ASMANEX HFA
US Patents and Regulatory Information for 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 Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-003 | Aug 12, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
European Patent Office | 1174139 | Utilisation du furoate de mometasone pour le traitement des affections pulmonaires et des voies respiratoires (Use of mometasone furoate for treating airway passage and lung diseases) | ⤷ Try a Trial |
Slovakia | 82296 | USE OF MOMETASONE FLUROATE FOR TREATING AIRWAY PASSAGE AND LUNG DISEASES | ⤷ Try a Trial |
Israel | 112459 | Use of mometasone furoate in the manufacture of a medicament for treating airway passage and lung diseases | ⤷ Try a Trial |
Germany | 69526425 | ⤷ Try a Trial | |
New Zealand | 279979 | Aerosolized formulation of mometasone furoate and it's use in treating airway passage and lung disease | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ASMANEX HFA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3043773 | 2190041-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426 |
3043773 | 132021000000191 | Italy | ⤷ Try a Trial | 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 |
0548114 | SPC/GB97/064 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410 |
3043773 | 21C1057 | France | ⤷ Try a Trial | 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 |
3043773 | 2022C/520 | Belgium | ⤷ Try a Trial | PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |