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, 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, Quagen, 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 eleven drug master file entries for fluocinolone acetonide. Nineteen 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:	11
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	32
Patent Applications:	6,809
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
EyePoint Pharmaceuticals, Inc.	Phase 4
CBCC Global Research	Phase 4
Centre Hospitalier Universitaire Dijon	Phase 4

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
Galderma Labs Lp	TRI-LUMA	fluocinolone acetonide; hydroquinone; tretinoin	CREAM;TOPICAL	021112-001	Jan 18, 2002		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Eyepoint Pharms	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Allergan Herbert	FLUONID	fluocinolone acetonide	GEL;TOPICAL	087300-001	May 27, 1982		DISCN	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 fluocinolone acetonide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eyepoint Pharms	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	See Plans and Pricing	See Plans and Pricing
Eyepoint Pharms	YUTIQ	fluocinolone acetonide	IMPLANT;INTRAVITREAL	210331-001	Oct 12, 2018	See Plans and Pricing	See Plans and Pricing
Alimera Sciences Inc	ILUVIEN	fluocinolone acetonide	IMPLANT;INTRAVITREAL	201923-001	Sep 26, 2014	See Plans and Pricing	See Plans and Pricing
>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
Spain	2340389		See Plans and Pricing
Germany	602004024642		See Plans and Pricing
Spain	2379466		See Plans and Pricing
>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	See Plans and Pricing	PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
2233112	132014902285293	Italy	See Plans and Pricing	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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