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FLOVENT HFA Drug Profile
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This drug has eighty-one patent family members in thirty-four countries.
The generic ingredient in FLOVENT HFA is fluticasone propionate. There are twenty-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
Summary for Tradename: FLOVENT HFA
| Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 5 |
| Drug Prices: : | see details |
Pharmacology for Tradename: FLOVENT HFA
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Clinical Trials for: FLOVENT HFA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-001 | May 14, 2004 | RX | Yes | 7,107,986*PED | Dec 8, 2018 | Y | |||||||||||||||||||
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-001 | May 14, 2004 | RX | Yes | 6,170,717*PED | Jun 23, 2018 | Y | |||||||||||||||||||
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-001 | May 14, 2004 | RX | Yes | 7,832,351*PED | Dec 19, 2023 | Y | |||||||||||||||||||
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Expired Patents for Tradename: FLOVENT HFA
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-001 | May 14, 2004 | 6,546,928*PED | <disabled> | ||||||||||||||||||||||
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | 5,674,472*PED | <disabled> | ||||||||||||||||||||||
Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | May 14, 2004 | 5,658,549*PED | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Tradename: FLOVENT HFA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,101,534 | Suspension aerosol formulations | <disabled in preview> | |||||||||||||||||||||||||||
| 7,105,152 | Suspension aerosol formulations | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Tradename: FLOVENT HFA
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 1234297 | <disabled in preview> | |||||||||||||||||||||||||||
| New Zealand | 246421 | <disabled in preview> | |||||||||||||||||||||||||||
| European Patent Office | 1086688 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: FLOVENT HFA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB08/026 | United Kingdom | <disabled> | PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111 | ||||||||||||||||||||||||||
| C0014 | France | <disabled> | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 | ||||||||||||||||||||||||||
| C0067 | France | <disabled> | PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215 | ||||||||||||||||||||||||||
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