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Fluocinonide - Generic Drug Details
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What are the generic drug sources for fluocinonide and what is the scope of freedom to operate?
Fluocinonide
is the generic ingredient in five branded drugs marketed by Amneal, Cadila, Cosette, Fougera Pharms Inc, Glenmark Generics, Perrigo Israel, Perrigo New York, Taro, Teligent, Teva, Fougera Pharms, Taro Pharm Inds Ltd, Cnty Line Pharms, Medicis, Novel Labs Inc, Xiromed, Encube Ethicals, Glasshouse Pharms, Macleods Pharms Ltd, Teva Pharms, and Zydus Pharms, and is included in forty-six NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Fluocinonide has eleven patent family members in nine countries.
There are nine drug master file entries for fluocinonide. Thirty-three suppliers are listed for this compound.
Summary for fluocinonide
International Patents: | 11 |
US Patents: | 4 |
Tradenames: | 5 |
Applicants: | 21 |
NDAs: | 46 |
Drug Master File Entries: | 9 |
Suppliers / Packagers: | 33 |
Bulk Api Vendors: | 61 |
Clinical Trials: | 8 |
Patent Applications: | 6,723 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for fluocinonide |
Drug Sales Revenues: | Drug sales revenues for fluocinonide |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for fluocinonide |
What excipients (inactive ingredients) are in fluocinonide? | fluocinonide excipients list |
DailyMed Link: | fluocinonide at DailyMed |
Recent Clinical Trials for fluocinonide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Rochester General Hospital | N/A |
Rochester Skin Lymphoma Medical Group, PLLC | N/A |
Valeant Pharmaceuticals International, Inc. | N/A |
Pharmacology for fluocinonide
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for fluocinonide
Paragraph IV (Patent) Challenges for FLUOCINONIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
VANOS | CREAM;TOPICAL | fluocinonide | 021758 | 2008-01-31 |
LIDEX | OINTMENT;TOPICAL | fluocinonide | 016909 |
US Patents and Regulatory Information for fluocinonide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Medicis | VANOS | fluocinonide | CREAM;TOPICAL | 021758-001 | Feb 11, 2005 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Taro | FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 071500-001 | Jun 10, 1987 | AB1 | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Medicis | VANOS | fluocinonide | CREAM;TOPICAL | 021758-001 | Feb 11, 2005 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Encube Ethicals | FLUOCINONIDE | fluocinonide | SOLUTION;TOPICAL | 209699-001 | Nov 29, 2018 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Teva | FLUOCINONIDE | fluocinonide | SOLUTION;TOPICAL | 072511-001 | Feb 7, 1989 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Cosette | FLUOCINONIDE | fluocinonide | GEL;TOPICAL | 072537-001 | Feb 7, 1989 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Teligent | FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 211758-001 | Apr 3, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
>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 fluocinonide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cnty Line Pharms | LIDEX | fluocinonide | CREAM;TOPICAL | 016908-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Cnty Line Pharms | LIDEX | fluocinonide | CREAM;TOPICAL | 016908-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
Cnty Line Pharms | LIDEX | fluocinonide | OINTMENT;TOPICAL | 016909-002 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fluocinonide
Country | Patent Number | Estimated Expiration |
---|---|---|
Israel | 162581 | Start Trial |
World Intellectual Property Organization (WIPO) | 03055445 | Start Trial |
Mexico | PA04006014 | Start Trial |
Brazil | 0215254 | Start Trial |
European Patent Office | 2363150 | Start Trial |
Australia | 2002360589 | Start Trial |
Japan | 2010280689 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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