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Generated: June 23, 2017
What are the generic drug sources for fluticasone propionate and what is the scope of fluticasone propionate patent protection?
Fluticasone propionate is the generic ingredient in fifteen branded drugs marketed by Fougera Pharms, West-ward Pharms Int, Glaxosmithkline, Glaxo Grp Ltd, Tolmar, Glaxosmithkline Cons, Apotex Inc, Taro Pharm Inds, Perrigo Israel, G And W Labs, Glenmark Generics, Nesher Pharms, Perrigo New York, Hi Tech Pharma, Wockhardt, and Teva Pharm, and is included in thirty NDAs. There are thirty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 15 |
| Patents: | 33 |
| Applicants: | 16 |
| NDAs: | 30 |
| Drug Master File Entries: see list | 22 |
| Suppliers / Packagers: see list | 72 |
| Bulk Api Vendors: see list | 52 |
| Clinical Trials: see list | 562 |
| Patent Applications: see list | 6,573 |
| Therapeutic Class: | Respiratory Tract Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | fluticasone propionate at DailyMed |
| Drug Class | Corticosteroid |
| Mechanism of Action | 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-003 | Jan 27, 2017 | RX | Yes | Yes | 6,446,627 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-001 | Jan 27, 2017 | RX | Yes | No | 8,714,149 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-003 | Jan 27, 2017 | RX | Yes | Yes | 9,463,288 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Taro Pharm Inds | FLUTICASONE PROPIONATE | fluticasone propionate | OINTMENT;TOPICAL | 077145-001 | Jun 14, 2005 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-001 | Jan 27, 2017 | RX | Yes | No | 9,216,260 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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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 | 021433-003 | May 14, 2004 | 6,251,368*PED | ► Subscribe | ||||||||||||||||||||||
Fougera Pharms | CUTIVATE | fluticasone propionate | OINTMENT;TOPICAL | 019957-001 | Dec 14, 1990 | 4,335,121*PED | ► Subscribe | ||||||||||||||||||||||
Glaxosmithkline | FLOVENT | fluticasone propionate | AEROSOL, METERED;INHALATION | 020548-001 | Mar 27, 1996 | 4,335,121*PED | ► Subscribe | ||||||||||||||||||||||
Glaxo Grp Ltd | FLOVENT DISKUS 250 | fluticasone propionate | POWDER;INHALATION | 020833-003 | Sep 29, 2000 | 5,590,645*PED | ► Subscribe | ||||||||||||||||||||||
Fougera Pharms | CUTIVATE | fluticasone propionate | CREAM;TOPICAL | 019958-001 | Dec 18, 1990 | 4,335,121*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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2,007,107,724 | ► Subscribe | ||||||||||||||||||||||||||||
| 9,526,850 | Dose counters for inhalers, inhalers and methods of assembly thereof | ► Subscribe | |||||||||||||||||||||||||||
| 5,860,419 | Inhalation device | ► Subscribe | |||||||||||||||||||||||||||
| 6,032,666 | Inhalation device | ► Subscribe | |||||||||||||||||||||||||||
| 7,101,534 | Suspension aerosol formulations | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 69218455 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2529358 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2559760 | ► Subscribe | |||||||||||||||||||||||||||
| Eurasian Patent Organization | 201291267 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2002528418 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||||||||||||||||||
| C0014 | France | ► Subscribe | PRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111 | ||||||||||||||||||||||||||
| 269 | Luxembourg | ► Subscribe | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
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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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