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ASMANEX HFA Drug Profile
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Which patents cover Asmanex Hfa, and what generic alternatives are available?
Asmanex Hfa is a drug marketed by Merck Sharp Dohme 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. Seventeen suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
US ANDA Litigation and Generic Entry Outlook for Asmanex Hfa
A generic version of ASMANEX HFA was approved as mometasone furoate by PERRIGO NEW YORK on March 18th, 2002.
Summary for ASMANEX HFA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 63 |
| Clinical Trials: | 10 |
| Patent Applications: | 5,433 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ASMANEX HFA |
| Drug Sales Revenues: | Drug sales revenues for ASMANEX HFA |
| 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 |
| Teva Pharmaceuticals USA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-003 | Aug 12, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | Start Trial | Start Trial |
| Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | Start Trial | Start Trial |
| Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | Start Trial | Start Trial |
| Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | Start Trial | Start Trial |
| Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | Start Trial | Start Trial |
| Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ASMANEX HFA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2369516 | Start Trial |
| European Patent Office | 1174138 | Start Trial |
| Portugal | 740550 | Start Trial |
| Mexico | 9602246 | Start Trial |
| Colombia | 4340692 | Start Trial |
| Portugal | 2156840 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ASMANEX HFA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0112669 | 96C0002 | Belgium | Start Trial | PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622 |
| 0548114 | SPC/GB97/064 | United Kingdom | Start Trial | 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 |
