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, Allied, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Hill Dermac, Anda Repository, Amneal, Padagis Israel, Quagen, Rising, Sciegen Pharms Inc, Trupharma, Glenmark Pharms Ltd, Novel Labs Inc, Pharmaderm, Galderma Labs Lp, Actavis Labs Ut Inc, Chartwell Rx, Encube Ethicals, Lupin, and Pai Holdings Pharm, and is included in seventy-nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for fluocinolone acetonide

International Patents:	177
US Patents:	2
Tradenames:	17
Applicants:	31
NDAs:	79
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	33
Patent Applications:	6,918
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
National Eye Institute (NEI)	Phase 3
Jaeb Center for Health Research	Phase 3
Genentech, Inc.	Phase 3

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

Anatomical Therapeutic Chemical (ATC) Classes for fluocinolone acetonide

US Patents and Regulatory Information for fluocinolone acetonide

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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
Perrigo New York	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	086810-001	Mar 4, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	SOLUTION;TOPICAL	206422-001	Sep 2, 2015	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	FLUCINOLONE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	210556-001	Oct 25, 2018	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hill Dermac	DERMA-SMOOTHE/FS	fluocinolone acetonide	OIL;TOPICAL	019452-002	Nov 9, 2005	AT	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	091514-001	Jun 25, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Invatech	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	088045-001	Dec 16, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	202847-001	Aug 9, 2013	AT	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 fluocinolone acetonide

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

International Patents for fluocinolone acetonide

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Country	Patent Number	Title	Estimated Expiration
Israel	175584	התקנים למתן חומר לשחרור מושהה בהזרקה (Injectable sustained release delivery devices)	⤷ Sign Up
South Korea	20050007377		⤷ Sign Up
Slovenia	1276462		⤷ Sign Up
Taiwan	200509998	Controlled release of highly soluble agents	⤷ Sign Up
Taiwan	I445559		⤷ Sign Up
Austria	410186		⤷ Sign Up
Cyprus	1114534		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for fluocinolone acetonide

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

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