Fluocinolone acetonide - Generic Drug Details
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What are the generic sources for fluocinolone acetonide and what is the scope of freedom to operate?
Fluocinolone acetonide
is the generic ingredient in seventeen branded drugs marketed by Alpharma Us Pharms, Allied, Cosette, Fougera Pharms Inc, MLV, Perrigo New York, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Eyepoint Pharms, Hill Dermac, Anda Repository, Akorn, Amneal, Lyne, Padagis Israel, Quagen, Tasman Pharma, Glenmark Pharms Ltd, Pharmaderm, Galderma Labs Lp, Actavis Labs Ut Inc, Encube Ethicals, Glasshouse Pharms, Lupin, and Pai Holdings Pharm, and is included in seventy-seven NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fluocinolone acetonide has one hundred and seventy-seven patent family members in twenty-seven countries.
There are eleven drug master file entries for fluocinolone acetonide. Twenty-one suppliers are listed for this compound.
Summary for fluocinolone acetonide
International Patents: | 177 |
US Patents: | 6 |
Tradenames: | 17 |
Applicants: | 31 |
NDAs: | 77 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 21 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
Clinical Trials: | 32 |
Patent Applications: | 6,808 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for fluocinolone acetonide |
What excipients (inactive ingredients) are in fluocinolone acetonide? | fluocinolone acetonide excipients list |
DailyMed Link: | fluocinolone acetonide at DailyMed |
Recent Clinical Trials for fluocinolone acetonide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
CBCC Global Research | Phase 4 |
EyePoint Pharmaceuticals, Inc. | Phase 4 |
Centre Hospitalier Universitaire Dijon | Phase 4 |
Pharmacology for fluocinolone acetonide
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for fluocinolone acetonide
US Patents and Regulatory Information for fluocinolone acetonide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Usl Pharma | FLUOCINOLONE ACETONIDE | fluocinolone acetonide | CREAM;TOPICAL | 088757-001 | Feb 11, 1985 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Savage Labs | FLUOTREX | fluocinolone acetonide | SOLUTION;TOPICAL | 088171-001 | Mar 9, 1983 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for fluocinolone acetonide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Eyepoint Pharms | YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331-001 | Oct 12, 2018 | See Plans and Pricing | See Plans and Pricing |
Bausch And Lomb | RETISERT | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 021737-001 | Apr 8, 2005 | See Plans and Pricing | See Plans and Pricing |
Alimera Sciences Inc | ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923-001 | Sep 26, 2014 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fluocinolone acetonide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | PA02010442 | DISPOSITIVO DE ADMINISTRACION DE FARMACOS DE LIBERACION PROLONGADA, METODOS DE USO, Y METODOS DE FABRICACION DE LOS MISMOS. (SUSTAINED RELEASE DRUG DELIVERY DEVICES, METHODS OF USE, AND METHODS OF MANUFACTURING THEREOF.) | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2004066979 | See Plans and Pricing | |
Poland | 2233112 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fluocinolone acetonide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2233112 | 122014000063 | Germany | See Plans and Pricing | PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504 |
2233112 | 132014902285293 | Italy | See Plans and Pricing | PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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