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, Encube, Fougera Pharms Inc, Glenmark Generics, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Taro, Teva, Fougera Pharms, Taro Pharm Inds Ltd, Alvogen, Bausch, 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 three 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-one suppliers are listed for this compound.

Summary for fluocinonide

International Patents:	11
US Patents:	3
Tradenames:	5
Applicants:	22
NDAs:	46
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	8
Patent Applications:	6,637
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

Drug Sales Revenue Trends for fluocinonide

See drug sales revenues for fluocinonide

Recent Clinical Trials for fluocinonide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rochester Skin Lymphoma Medical Group, PLLC	N/A
Rochester General Hospital	N/A
Bausch Health Americas, 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	Strength	NDA	ANDAs Submitted	Submissiondate
VANOS	Cream	fluocinonide	0.1%	021758	1	2008-01-31

US Patents and Regulatory Information for fluocinonide

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xiromed	FLUOCINONIDE	fluocinonide	OINTMENT;TOPICAL	212976-001	Nov 26, 2019	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Novel Labs Inc	FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	206003-001	Jul 21, 2017	AT	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Teva Pharms	FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	072522-001	Sep 28, 1990		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Pai Holdings Pharm	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	211758-001	Apr 3, 2019	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				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 fluocinonide

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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	See Plans and Pricing	See Plans and Pricing
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	See Plans and Pricing	See Plans and Pricing
Bausch	VANOS	fluocinonide	CREAM;TOPICAL	021758-001	Feb 11, 2005	See Plans and Pricing	See Plans and Pricing
Alvogen	LIDEX	fluocinonide	OINTMENT;TOPICAL	016909-002	Approved Prior to Jan 1, 1982	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fluocinonide

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Country	Patent Number	Title	Estimated Expiration
Israel	162581		See Plans and Pricing
Japan	2005524614		See Plans and Pricing
China	1617730		See Plans and Pricing
Canada	2471041	COMPOSITIONS ET PROCEDES FAVORISANT L'ADMINISTRATION DE CORTICOSTEROIDES (COMPOSITIONS AND METHODS FOR ENHANCING CORTICOSTERIOD DELIVERY)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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