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Generated: June 27, 2017
What are the generic drug sources for fluocinolone acetonide and what is the scope of fluocinolone acetonide patent protection?
Fluocinolone acetonide is the generic ingredient in thirteen branded drugs marketed by Allergan Herbert, Galderma Labs Lp, Taro, Akorn, Pharmafair, Identi Pharms Inc, Perrigo New York, Morton Grove, Gavis Pharms Llc, Alimera Sciences Inc, G And W Labs, Bausch And Lomb, G And W Labs Inc, Usl Pharma, Pharmaderm, Perrigo Israel, Hill Dermac, Alpharma Us Pharms, Medimetriks Pharms, Fougera Pharms Inc, Savage Labs, Lyne, and Actavis Labs Ut Inc, and is included in sixty-four NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 13 |
| Patents: | 10 |
| Applicants: | 23 |
| NDAs: | 64 |
| Drug Master File Entries: see list | 12 |
| Suppliers / Packagers: see list | 22 |
| Bulk Api Vendors: see list | 42 |
| Clinical Trials: see list | 149 |
| Patent Applications: see list | 5,522 |
| Therapeutic Class: | Otic Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | fluocinolone acetonide 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galderma Labs Lp | CAPEX | fluocinolone acetonide | SHAMPOO;TOPICAL | 020001-001 | Aug 27, 1990 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Pharmaderm | FLUOCINOLONE ACETONIDE | fluocinolone acetonide | CREAM;TOPICAL | 088047-001 | Dec 16, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | 8,247,395 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Hill Dermac | DERMA-SMOOTHE/FS | fluocinolone acetonide | OIL;TOPICAL | 019452-001 | Feb 3, 1988 | AT | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Medimetriks Pharms | SYNALAR | fluocinolone acetonide | CREAM;TOPICAL | 012787-004 | Approved Prior to Jan 1, 1982 | AT | RX | Yes | Yes | ► Subscribe | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,815,284 | Bioerodible sustained release drug delivery systems | ► Subscribe | |||||||||||||||||||||||||||
| 9,566,336 | In situ gelling drug delivery system | ► Subscribe | |||||||||||||||||||||||||||
| 7,439,249 | Inhibitors of phosphatases | ► Subscribe | |||||||||||||||||||||||||||
| 8,574,659 | Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof | ► Subscribe | |||||||||||||||||||||||||||
| 9,192,579 | Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 4174800 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5661226 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 2233112 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | I290054 | ► Subscribe | |||||||||||||||||||||||||||
| Cyprus | 1114534 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014000063 | Germany | ► Subscribe | PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504 | ||||||||||||||||||||||||||
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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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