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 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-four 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.
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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: | 4,548 |
| 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 |
|---|---|
| Milton S. Hershey Medical Center | Phase 3 |
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 |
| University of Dundee | Phase 4 |
Pharmacology for ASMANEX HFA
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | 205641-002 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Israel | 112459 | Use of mometasone furoate in the manufacture of a medicament for treating airway passage and lung diseases | ⤷ Sign Up |
| Austria | 518520 | ⤷ Sign Up | |
| European Patent Office | 1192946 | ⤷ Sign Up | |
| Portugal | 740550 | ⤷ Sign Up | |
| Japan | H09501700 | ⤷ Sign Up | |
| Hungary | 227837 | USE OF MOMETASONE FUROATE FOR THE PREPARATION OF PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OR AIRWAY PASSAGE AND LUNG DISEASES | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ASMANEX HFA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0548114 | SPC/GB97/064 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410 |
| 3043773 | 21C1057 | France | ⤷ Sign Up | 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 | 2190041-0 | Sweden | ⤷ Sign Up | 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 |
| 0112669 | 96C0002 | Belgium | ⤷ Sign Up | PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622 |
| 3043773 | 2022C/520 | Belgium | ⤷ Sign Up | PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203 |
| 3043773 | 132021000000191 | Italy | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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