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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, 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, Perrigo Israel, Glenmark Pharms Ltd, Pharmaderm, Galderma Labs Lp, Actavis Labs Ut Inc, Encube Ethicals, Glasshouse Pharms, Lupin, and Morton Grove, and is included in seventy-three NDAs. There are ten 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 suppliers are listed for this compound.
Summary for fluocinolone acetonide
| International Patents: | 176 |
| US Patents: | 10 |
| Tradenames: | 17 |
| Applicants: | 28 |
| NDAs: | 73 |
| Drug Master File Entries: | 12 |
| Suppliers / Packagers: | 20 |
| Bulk Api Vendors: | 65 |
| Clinical Trials: | 28 |
| Patent Applications: | 4,399 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for fluocinolone acetonide |
| DailyMed Link: | fluocinolone acetonide at DailyMed |
Recent Clinical Trials for fluocinolone acetonide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pradeepa Yoganathan | Phase 2 |
| St. Michael's Hospital, Toronto | Phase 2 |
| Alimera Sciences | Phase 4 |
Pharmacology for fluocinolone acetonide
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eyepoint Pharms | YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331-001 | Oct 12, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Allergan Herbert | FLUONID | fluocinolone acetonide | CREAM;TOPICAL | 087156-002 | Sep 6, 1984 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Glasshouse Pharms | FLUOCINOLONE ACETONIDE | fluocinolone acetonide | SOLUTION;TOPICAL | 209596-001 | Dec 26, 2017 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Eyepoint Pharms | YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331-001 | Oct 12, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cosette | FLUOCINOLONE ACETONIDE | fluocinolone acetonide | SOLUTION;TOPICAL | 207441-001 | Sep 28, 2016 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Pharmaderm | FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OINTMENT;TOPICAL | 088046-001 | Dec 16, 1982 | DISCN | No | No | Start Trial | Start Trial | Start 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Eyepoint Pharms | YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331-001 | Oct 12, 2018 | Start Trial | Start Trial |
| Alimera Sciences Inc | ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923-001 | Sep 26, 2014 | Start Trial | Start Trial |
| Bausch And Lomb | RETISERT | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 021737-001 | Apr 8, 2005 | Start Trial | Start Trial |
| Eyepoint Pharms | YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331-001 | Oct 12, 2018 | Start Trial | Start Trial |
| Eyepoint Pharms | YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331-001 | Oct 12, 2018 | Start Trial | Start Trial |
| Eyepoint Pharms | YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331-001 | Oct 12, 2018 | Start Trial | Start Trial |
| Eyepoint Pharms | YUTIQ | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 210331-001 | Oct 12, 2018 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fluocinolone acetonide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20062362 | Start Trial |
| Australia | 2008261114 | Start Trial |
| Denmark | 1592407 | Start Trial |
| Spain | 2447816 | Start Trial |
| Eurasian Patent Organization | 004980 | Start Trial |
| Cyprus | 1108685 | Start Trial |
| Spain | 2340389 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for fluocinolone acetonide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2233112 | 132014902285293 | Italy | Start Trial | PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504 |
| 2233112 | 122014000063 | Germany | Start Trial | 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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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.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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