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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

See drug prices for fluocinonide

See drug sales revenues for fluocinonide

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

See all fluocinonide clinical trials

Pharmacology for fluocinonide

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for fluocinonide

Anti-Allergic Agents

Anti-Inflammatory Agents

Glucocorticoids

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			Y
Taro	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	071500-001	Jun 10, 1987	AB1	RX	No	No
Medicis	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	AB	RX	Yes	Yes
Encube Ethicals	FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	209699-001	Nov 29, 2018	AT	RX	No	No
Teva	FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	072511-001	Feb 7, 1989		DISCN	No	No
Cosette	FLUOCINONIDE	fluocinonide	GEL;TOPICAL	072537-001	Feb 7, 1989	AB	RX	No	No
Teligent	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	211758-001	Apr 3, 2019	AB	RX	No	No

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
Cnty Line Pharms	LIDEX	fluocinonide	CREAM;TOPICAL	016908-002	Approved Prior to Jan 1, 1982
Cnty Line Pharms	LIDEX	fluocinonide	OINTMENT;TOPICAL	016909-002	Approved Prior to Jan 1, 1982

International Patents for fluocinonide

Country	Patent Number	Estimated Expiration
Israel	162581
World Intellectual Property Organization (WIPO)	03055445
Mexico	PA04006014
Brazil	0215254
European Patent Office	2363150
Australia	2002360589
Japan	2010280689