FLUOCINONIDE - Generic Drug Details
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What are the generic sources for fluocinonide and what is the scope of patent protection?
Fluocinonide
is the generic ingredient in five branded drugs marketed by Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Taro, Teva, Zydus Lifesciences, Fougera Pharms, Alvogen, Bausch, Padagis Us, Chartwell Rx, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Teva Pharms, and Zydus Pharms, and is included in forty-six NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for fluocinonide. Twenty-nine suppliers are listed for this compound.
Summary for FLUOCINONIDE
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 22 |
NDAs: | 46 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 29 |
Raw Ingredient (Bulk) Api Vendors: | 72 |
Clinical Trials: | 9 |
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 |
---|---|
University of Catania | N/A |
Rochester General Hospital | N/A |
Bausch Health Americas, Inc. | N/A |
Pharmacology for FLUOCINONIDE
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for FLUOCINONIDE
Anatomical Therapeutic Chemical (ATC) Classes for FLUOCINONIDE
Paragraph IV (Patent) Challenges for FLUOCINONIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VANOS | Cream | fluocinonide | 0.1% | 021758 | 1 | 2008-01-31 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Taro | FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 071500-001 | Jun 10, 1987 | AB1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Zydus Pharms | FLUOCINONIDE | fluocinonide | SOLUTION;TOPICAL | 208948-001 | Jul 17, 2018 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fougera Pharms Inc | FLUOCINONIDE | fluocinonide | SOLUTION;TOPICAL | 072934-001 | Feb 27, 1995 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Alvogen | LIDEX | fluocinonide | SOLUTION;TOPICAL | 018849-001 | Apr 6, 1984 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Fougera Pharms | FLUOCINONIDE | fluocinonide | OINTMENT;TOPICAL | 074905-001 | Aug 26, 1997 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chartwell Rx | FLUOCINONIDE | fluocinonide | OINTMENT;TOPICAL | 207538-001 | Jul 31, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 |
---|---|---|---|---|---|---|---|
Alvogen | LIDEX | fluocinonide | CREAM;TOPICAL | 016908-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | VANOS | fluocinonide | CREAM;TOPICAL | 021758-001 | Feb 11, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | VANOS | fluocinonide | CREAM;TOPICAL | 021758-001 | Feb 11, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Alvogen | LIDEX | fluocinonide | OINTMENT;TOPICAL | 016909-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | VANOS | fluocinonide | CREAM;TOPICAL | 021758-001 | Feb 11, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | VANOS | fluocinonide | CREAM;TOPICAL | 021758-001 | Feb 11, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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