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Last Updated: April 18, 2024

FLUOCINOLONE ACETONIDE - Generic Drug Details

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What are the generic sources for fluocinolone acetonide and what is the scope of patent protection?

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, Patrin, Amneal, Lyne, Padagis Israel, Quagen, Saptalis Pharms, Tasman Pharma, 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-four 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:	24
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	33
Patent Applications:	6,845
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
National Institutes of Health (NIH)	Phase 3
National Eye Institute (NEI)	Phase 3
Jaeb Center for Health Research	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

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
Fougera Pharms Inc	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	CREAM;TOPICAL	088169-001	Dec 16, 1982	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Tasman Pharma	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OIL/DROPS;OTIC	213264-001	Feb 5, 2021	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Medimetriks Pharms	SYNALAR	fluocinolone acetonide	OINTMENT;TOPICAL	013960-001	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hill Dermac	DERMA-SMOOTHE/FS	fluocinolone acetonide	OIL;TOPICAL	019452-001	Feb 3, 1988	AT	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lyne	FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	203377-001	Apr 25, 2016	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Medimetriks Pharms	SYNALAR	fluocinolone acetonide	CREAM;TOPICAL	012787-005	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glenmark Pharms Ltd	FLUOCINONIDE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	210539-001	Oct 26, 2018	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	⤷ Try a Trial	⤷ Try a Trial
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	⤷ Try a Trial	⤷ Try a Trial
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005	⤷ Try a Trial	⤷ Try a Trial
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	⤷ Try a Trial	⤷ Try a Trial
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	⤷ Try a Trial	⤷ Try a Trial
Alimera Sciences Inc	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	⤷ Try a Trial	⤷ Try a Trial
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005	⤷ Try a Trial	⤷ Try a Trial
>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
Slovenia	2233112		⤷ Try a Trial
South Korea	20050118161	SUSTAINED RELEASE AND METHOD FOR OCULAR DELIVERY OF ADRENERGIC AGENTS	⤷ Try a Trial
Argentina	047552	SISTEMAS DE SUMINISTRO DE FARMACOS DE LIBERACION SOSTENIDA BIODEGRADABLES	⤷ Try a Trial
Japan	2011093944	BIODEGRADABLE SUSTAINED RELEASE DRUG DELIVERY SYSTEM	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2005051234		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2005000268		⤷ Try a Trial
Taiwan	I496597		⤷ Try a Trial
>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	122014000063	Germany	⤷ Try a Trial	PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
2233112	132014902285293	Italy	⤷ Try a Trial	PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.