➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Colorcon
Boehringer Ingelheim
AstraZeneca
McKesson

Last Updated: October 24, 2021

DrugPatentWatch Database Preview

Fluocinolone acetonide - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

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
Drug Prices for fluocinolone acetonide

See drug prices for fluocinolone acetonide

Recent Clinical Trials for fluocinolone acetonide

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

SponsorPhase
Centre Hospitalier Universitaire DijonPhase 4
Lee's Pharmaceutical LimitedPhase 3
Pradeepa YoganathanPhase 2

See all fluocinolone acetonide clinical trials

Pharmacology for fluocinolone acetonide
Medical Subject Heading (MeSH) Categories for fluocinolone acetonide

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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Taro FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL;TOPICAL 209336-001 May 19, 2016 AT RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Invatech FLUOCINOLONE ACETONIDE fluocinolone acetonide CREAM;TOPICAL 088047-001 Dec 16, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Usl Pharma FLUOCINOLONE ACETONIDE fluocinolone acetonide CREAM;TOPICAL 088756-001 Mar 28, 1985 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Medimetriks Pharms NEO-SYNALAR fluocinolone acetonide; neomycin sulfate CREAM;TOPICAL 060700-001 Approved Prior to Jan 1, 1982 RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan Herbert FLUONID fluocinolone acetonide SOLUTION;TOPICAL 087158-001 Mar 17, 1983 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Glenmark Pharms Ltd FLUOCINONIDE ACETONIDE fluocinolone acetonide OIL/DROPS;OTIC 211815-001 Dec 14, 2018 AT RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

International Patents for fluocinolone acetonide

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

Supplementary Protection Certificates for fluocinolone acetonide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2233112 122014000063 Germany ⤷  Free Forever Trial PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
2233112 132014902285293 Italy ⤷  Free Forever 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Colorcon
Boehringer Ingelheim
AstraZeneca
McKesson

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.