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Fluocinolone acetonide - Generic Drug Details

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What are the generic sources for fluocinolone acetonide and what is the scope of freedom to operate?

Fluocinolone acetonide is the generic ingredient in seventeen branded drugs marketed by Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Eyepoint Pharms, Hill Dermac, Anda Repository, Akorn, Amneal, Lyne, Padagis Israel, Solaris Pharma Corp, Tasman Pharma, Glenmark Pharms Ltd, Pharmaderm, Galderma Labs Lp, Actavis Labs Ut Inc, Encube Ethicals, Glasshouse Pharms, Lupin, and Morton Grove, and is included in seventy-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluocinolone acetonide has one hundred and seventy-six patent family members in twenty-seven countries.

There are twelve drug master file entries for fluocinolone acetonide. Twenty-one suppliers are listed for this compound.

Summary for fluocinolone acetonide

International Patents:	176
US Patents:	5
Tradenames:	17
Applicants:	30
NDAs:	77
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	30
Patent Applications:	6,778
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fluocinolone acetonide
What excipients (inactive ingredients) are in fluocinolone acetonide?	fluocinolone acetonide excipients list
DailyMed Link:	fluocinolone acetonide at DailyMed

See drug prices for fluocinolone acetonide

Recent Clinical Trials for fluocinolone acetonide

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

Sponsor	Phase
Centre Hospitalier Universitaire Dijon	Phase 4
Lee's Pharmaceutical Limited	Phase 3
Pradeepa Yoganathan	Phase 2

See all fluocinolone acetonide clinical trials

Pharmacology for fluocinolone acetonide

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for fluocinolone acetonide

Anti-Inflammatory Agents

Glucocorticoids

US Patents and Regulatory Information for fluocinolone acetonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmafair	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OINTMENT;TOPICAL	088507-001	Feb 27, 1984		DISCN	No	No
Taro	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	209336-001	May 19, 2016	AT	RX	No	No
Invatech	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	088047-001	Dec 16, 1982		DISCN	No	No
Usl Pharma	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	088756-001	Mar 28, 1985		DISCN	No	No
Medimetriks Pharms	NEO-SYNALAR	fluocinolone acetonide; neomycin sulfate	CREAM;TOPICAL	060700-001	Approved Prior to Jan 1, 1982		RX	No	Yes
Allergan Herbert	FLUONID	fluocinolone acetonide	SOLUTION;TOPICAL	087158-001	Mar 17, 1983		DISCN	No	No
Glenmark Pharms Ltd	FLUOCINONIDE ACETONIDE	fluocinolone acetonide	OIL/DROPS;OTIC	211815-001	Dec 14, 2018	AT	RX	No	No

Expired US Patents for fluocinolone acetonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005
Eyepoint Pharms	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014
Eyepoint Pharms	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018
Eyepoint Pharms	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018
Eyepoint Pharms	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014

International Patents for fluocinolone acetonide

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005002625
Taiwan	200514581
European Patent Office	1592408
China	101513386
European Patent Office	1635875
Denmark	1696822
Austria	409023

Supplementary Protection Certificates for fluocinolone acetonide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2233112	122014000063	Germany		PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
2233112	132014902285293	Italy		PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504