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Serving leading biopharmaceutical companies globally:

Deloitte
Moodys
Merck
Healthtrust
US Army
Cerilliant
Covington
Johnson and Johnson
Harvard Business School
Express Scripts

Generated: January 22, 2018

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Fluocinolone acetonide - Generic Drug Details

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

Fluocinolone acetonide
is the generic ingredient in thirteen branded drugs marketed by Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs, Perrigo New York, Pharmaderm, Pharmafair, Taro, Usl Pharma, Allergan Herbert, Savage Labs, Medimetriks Pharms, Alimera Sciences Inc, Bausch And Lomb, Hill Dermac, Akorn, Identi Pharms Inc, Lyne, Perrigo Israel, Galderma Labs Lp, Actavis Labs Ut Inc, G And W Labs Inc, Gavis Pharms Llc, and Morton Grove, and is included in sixty-five NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluocinolone acetonide has one hundred and eighty-three patent family members in twenty-six countries.

There are twelve drug master file entries for fluocinolone acetonide. Twenty-three suppliers are listed for this compound.
Summary for fluocinolone acetonide
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
Galderma Labs Lp CAPEX fluocinolone acetonide SHAMPOO;TOPICAL 020001-001 Aug 27, 1990 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Taro FLUOCINOLONE ACETONIDE fluocinolone acetonide OINTMENT;TOPICAL 040041-001 Sep 15, 1994 AT RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Medimetriks Pharms SYNALAR-HP fluocinolone acetonide CREAM;TOPICAL 016161-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bausch And Lomb RETISERT fluocinolone acetonide IMPLANT;INTRAVITREAL 021737-001 Apr 8, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Alimera Sciences Inc ILUVIEN fluocinolone acetonide IMPLANT;INTRAVITREAL 201923-001 Sep 26, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Hill Dermac DERMOTIC fluocinolone acetonide OIL/DROPS;OTIC 019452-003 Nov 9, 2005 AT RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Allergan Herbert FLUONID fluocinolone acetonide OINTMENT;TOPICAL 087157-001 Sep 6, 1984 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Medimetriks Pharms SYNALAR fluocinolone acetonide SOLUTION;TOPICAL 015296-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Savage Labs FLUOTREX fluocinolone acetonide SOLUTION;TOPICAL 088171-001 Mar 9, 1983 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for fluocinolone acetonide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,439,249 Inhibitors of phosphatases ➤ Subscribe
9,192,579 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof ➤ Subscribe
9,566,336 In situ gelling drug delivery system ➤ Subscribe
8,574,613 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof ➤ Subscribe
8,574,659 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof ➤ Subscribe
8,815,284 Bioerodible sustained release drug delivery systems ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for fluocinolone acetonide

Supplementary Protection Certificates for fluocinolone acetonide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000063 Germany ➤ Subscribe PRODUCT NAME: FLUOCINOLONACETONID; NAT. REGISTRATION NO/DATE: 82809.00.00 20120720; FIRST REGISTRATION: GB PL 27813/0001 20120504
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Healthtrust
Moodys
Medtronic
McKinsey
Federal Trade Commission
Fuji
Argus Health
QuintilesIMS
Johnson and Johnson

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 verifification 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.

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