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ADVAIR DISKUS 100/50 Drug Profile
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This drug has seventy-eight patent family members in forty-one countries.
The generic ingredient in ADVAIR DISKUS 100/50 is fluticasone propionate; salmeterol xinafoate. There are twenty-one drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for Tradename: ADVAIR DISKUS 100/50
| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 9 |
| Formulation / Manufacturing: | see details |
| Drug Prices: : | see details |
Pharmacology for Tradename: ADVAIR DISKUS 100/50
| Drug Class | beta2-Adrenergic Agonist Corticosteroid |
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Clinical Trials for: ADVAIR DISKUS 100/50
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | RX | Yes | 5,873,360*PED | Aug 23, 2016 | Y | |||||||||||||||||||
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Expired Patents for Tradename: ADVAIR DISKUS 100/50
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | 7,225,808*PED | <disabled> | ||||||||||||||||||||||
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | 4,335,121*PED | <disabled> | ||||||||||||||||||||||
Glaxo Grp Ltd | ADVAIR DISKUS 100/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-001 | Aug 24, 2000 | 5,860,419*PED | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Tradename: ADVAIR DISKUS 100/50
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2,006,107,948 | <disabled in preview> | ||||||||||||||||||||||||||||
| 6,792,945 | Inhalation device | <disabled in preview> | |||||||||||||||||||||||||||
| 7,225,808 | Inhalation device | <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: ADVAIR DISKUS 100/50
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Denmark | 175075 | <disabled in preview> | |||||||||||||||||||||||||||
| Poland | 167736 | <disabled in preview> | |||||||||||||||||||||||||||
| Canada | 2037421 | <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.
Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: ADVAIR DISKUS 100/50
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0014 | France | <disabled> | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 | ||||||||||||||||||||||||||
| 269 | Luxembourg | <disabled> | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
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