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, 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:	8
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

Anatomical Therapeutic Chemical (ATC) Classes for fluocinonide

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

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
Amneal	FLUOCINONIDE	fluocinonide	CREAM;TOPICAL	211111-001	Jun 4, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	FLUOCINONIDE	fluocinonide	OINTMENT;TOPICAL	212976-001	Nov 26, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	FLUOCINONIDE	fluocinonide	OINTMENT;TOPICAL	073481-001	Dec 27, 1991	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	CREAM;TOPICAL	016908-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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