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Generated: June 28, 2017
What is the patent landscape for Advair Diskus 250/50, and what generic Advair Diskus 250/50 alternatives are available?
Advair Diskus 250/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There is one patent protecting this drug.| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 8 |
| Clinical Trials: see list | 1,400 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | ADVAIR DISKUS 250/50 at DailyMed |
| Drug Class | beta2-Adrenergic Agonist Corticosteroid |
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | RX | Yes | Yes | 5,873,360*PED | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | 7,225,808*PED | ► Subscribe | ||||||||||||||||||||||
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | 7,389,775*PED | ► Subscribe | ||||||||||||||||||||||
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | 5,225,445*PED | ► Subscribe | ||||||||||||||||||||||
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | 6,378,519*PED | ► Subscribe | ||||||||||||||||||||||
Glaxo Grp Ltd | ADVAIR DISKUS 250/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-002 | Aug 24, 2000 | 5,290,815*PED | ► Subscribe | ||||||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,860,419 | Inhalation device | ► Subscribe | |||||||||||||||||||||||||||
| 6,378,519 | Inhalation device | ► Subscribe | |||||||||||||||||||||||||||
| 2,006,107,948 | ► Subscribe | ||||||||||||||||||||||||||||
| 5,590,645 | Inhalation device | ► Subscribe | |||||||||||||||||||||||||||
| 7,389,775 | Inhalation device | ► Subscribe | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Russian Federation | 2075977 | ► Subscribe | |||||||||||||||||||||||||||
| Czech Republic | 9601807 | ► Subscribe | |||||||||||||||||||||||||||
| United Kingdom | 9404023 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 237274 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 9110367 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 269 | Luxembourg | ► Subscribe | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE | ||||||||||||||||||||||||||
| C0067 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C/GB08/026 | United Kingdom | ► Subscribe | 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 | ► Subscribe | PRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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