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Fluocinolone Acetonide Patent Expiration

Fluocinolone Acetonide is Used for managing chronic non-infectious uveitis affecting the posterior segment of the eye. It was first introduced by Medimetriks Pharmaceuticals Inc in its drug Synalar on Approved Prior to Jan 1, 1982. Other drugs containing Fluocinolone Acetonide are Retisert, Synalar-Hp, Yutiq, Derma-Smoothe/Fs, Iluvien, Capex, Dermotic. 31 different companies have introduced drugs containing Fluocinolone Acetonide.


Fluocinolone Acetonide Patents

Given below is the list of patents protecting Fluocinolone Acetonide, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Iluvien US9849027 Ocular implantation device Nov 07, 2028 Alimera Sciences Inc
Yutiq US7998108 Injector apparatus and method of use Jan 12, 2028 Alimera Sciences Inc
Iluvien US8871241 Injectable sustained release delivery devices Aug 12, 2027 Alimera Sciences Inc
Yutiq US8871241 Injectable sustained release delivery devices Aug 12, 2027 Alimera Sciences Inc
Iluvien US6375972 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof Apr 26, 2020

(Expired)

 Alimera Sciences Inc
Yutiq US6375972 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof Apr 26, 2020

(Expired)

 Alimera Sciences Inc
Yutiq US8574613 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof Apr 26, 2020

(Expired)

 Alimera Sciences Inc
Yutiq US8574659 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof Apr 26, 2020

(Expired)

 Alimera Sciences Inc
Yutiq US9192579 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof Apr 26, 2020

(Expired)

 Alimera Sciences Inc
Yutiq US9849085 Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof Apr 26, 2020

(Expired)

 Alimera Sciences Inc
Iluvien US8252307 Method for treating and/or preventing retinal diseases with sustained release corticosteroids Jun 27, 2019

(Expired)

 Alimera Sciences Inc
Yutiq US8252307 Method for treating and/or preventing retinal diseases with sustained release corticosteroids Jun 27, 2019

(Expired)

 Alimera Sciences Inc
Iluvien US6217895 Method for treating and/or preventing retinal diseases with sustained release corticosteroids Mar 22, 2019

(Expired)

 Alimera Sciences Inc
Iluvien US6548078 Method for treating and/or preventing retinal diseases with sustained release corticosteroids Mar 22, 2019

(Expired)

 Alimera Sciences Inc
Retisert US6217895 Method for treating and/or preventing retinal diseases with sustained release corticosteroids Mar 22, 2019

(Expired)

 Bausch And Lomb
Retisert US6548078 Method for treating and/or preventing retinal diseases with sustained release corticosteroids Mar 22, 2019

(Expired)

 Bausch And Lomb
Yutiq US6217895 Method for treating and/or preventing retinal diseases with sustained release corticosteroids Mar 22, 2019

(Expired)

 Alimera Sciences Inc
Yutiq US6548078 Method for treating and/or preventing retinal diseases with sustained release corticosteroids Mar 22, 2019

(Expired)

 Alimera Sciences Inc



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Fluocinolone Acetonide's patents.

Given below is the list recent legal activities going on the following patents of Fluocinolone Acetonide.

Activity Date Patent Number
Patent litigations
Expire Patent
Critical
 01 Jan, 2024 US9192579
Maintenance Fee Reminder Mailed
Critical
 17 Jul, 2023 US9192579
Payment of Maintenance Fee, 12th Year, Large Entity 01 Feb, 2023 US7998108
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 07 Apr, 2022 US7998108
Expire Patent
Critical
 31 Jan, 2022 US9849085
Expire Patent
Critical
 13 Dec, 2021 US8574613
Expire Patent
Critical
 13 Dec, 2021 US8574659
Maintenance Fee Reminder Mailed
Critical
 16 Aug, 2021 US9849085
Maintenance Fee Reminder Mailed
Critical
 28 Jun, 2021 US8574613
Maintenance Fee Reminder Mailed
Critical
 28 Jun, 2021 US8574659


Fluocinolone Acetonide's Family Patents

Family Patents

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Fluocinolone Acetonide Generic API Manufacturers

Several generic applications have been filed for Fluocinolone Acetonide. The first generic version for Fluocinolone Acetonide was by Perrigo New York Inc and was approved on Mar 4, 1982. And the latest generic version is by Novel Laboratories Inc and was approved on Aug 7, 2023.

Given below is the list of companies who have filed for Fluocinolone Acetonide generic, along with the locations of their manufacturing plants worldwide.


1. ACTAVIS LABS UT INC

Actavis Laboratories Ut Inc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Actavis Labs Ut Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

solution Discontinued TOPICAL N/A Oct 21, 2016





2. ALLERGAN HERBERT

Allergan Herbert Div Allergan Inc has filed for 2 different strengths of generic version for Fluocinolone Acetonide. All of these versions come by the name FLUONID. Given below are the details of the strengths of this generic introduced by Allergan Herbert.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.025%

cream Discontinued TOPICAL N/A Sep 6, 1984
0.01%

solution Discontinued TOPICAL N/A Mar 17, 1983





3. ALLIED

Allied Pharma Inc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Allied.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

solution Discontinued TOPICAL N/A Dec 16, 1982


Manufacturing Plant Locations
New

Allied's manufacturing plants are situated in 3 countries - United States, India, China. Given below are the details of these plant locations as well as the firm names of Allied as present at those locations.

Country City Firm Name
United States
Blomkest Allied Grain Company
Glen Burnie Allied Orthopedic Associates Inc
Bakersfield Allied Potato Inc.
Mauston Allied Cooperative
Gackle Allied Agronomy
Santa Maria Allied Central Coast Distributing
Bell Allied Blending LP
Saint Louis Allied Medical LLC
Glen Burnie Allied International Corporation of Virginia
Stratford Allied Cooperative
Corona Allied Merchandising Industry
Fords Allied Pharma Inc
Linden Allied Food Products Inc
Saint Louis Allied Medical Systems Inc
Stuyvesant Falls Allied Healthcare Products, Inc.
Tomah Allied Cooperative - Tomah
San Antonio Allied Feeds, Inc
Chicago Allied Beverage Tanks, Inc.
Keokuk Allied Blending LP
Trappe Allied Orthopedic Associates, Inc.
Brooklyn Allied Imports, Inc.
Moorhead Allied Meats
Keokuk ALLIED BLENDING LP
Millington Allied Analytical Laboratory Services Inc
Port Reading Allied Old English,Inc
Carrington Allied Grain
West Salem Allied Cooperative
Wisconsin Rapids Allied Cooperative
Tomah ALLIED
Kansas City Allied Materials & Equipment Co Inc
Calexico Allied, LLC
Cuero Allied Feeds, Inc
Miami Allied Biomedical Research Institute, Inc.
Washington Allied Aviation Fueling of National Airport LLC
New Rockford Allied Energy
Delray Beach Allied Pharmacy Products. Inc.
India
Sonepat Allied Natural Product
China
Dalian Allied Pacific Food (Dalian ) Co. Ltd.
Zhanjiang ALLIED PACIFIC AQUATIC PRODUCTS (ZHANJIANG) CO., LTD.





4. ALPHARMA US PHARMS

Alpharma Us Pharmaceuticals Division has filed for 2 different strengths of generic version for Fluocinolone Acetonide. Out of these 0.025% version comes by the name FLUOCET. Given below are the details of the strengths of this generic introduced by Alpharma Us Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

cream Discontinued TOPICAL N/A Jan 16, 1984
0.025%

cream Discontinued TOPICAL N/A Jan 16, 1984





5. AMNEAL

Amneal Pharmaceuticals Llc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

oil Discontinued TOPICAL N/A Oct 17, 2011


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Branchburg Amneal Pharmaceuticals, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Paterson Amneal Pharmaceuticals, Llc
Brookhaven Amneal Pharmaceuticals of New York, LLC
East Hanover Amneal Pharmaceuticals LLC
Piscataway Amneal Pharmaceuticals, LLC
Bridgewater Amneal Complex Products Research LLC
Glasgow Amneal Pharmaceuticals LLC
India
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.





6. ANDA REPOSITORY

Anda Repository Llc has filed for 1 generic for Fluocinolone Acetonide. This 0.01% version comes by the name FLAC. Given below are the details of the strengths of this generic introduced by Anda Repository.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

oil/drops Prescription OTIC AT Apr 11, 2018





7. BAUSCH AND LOMB

Bausch And Lomb Pharmaceuticals Inc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Bausch And Lomb.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

solution Discontinued TOPICAL N/A Dec 20, 1993


Manufacturing Plant Locations
New

Bausch And Lomb's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bausch And Lomb as present at those locations.

Country City Firm Name
United States
Rancho Cucamonga Bausch and Lomb, Incorporated
Bridgewater Bausch and Lomb, Inc
Irvine Bausch and Lomb, Incorporated





8. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

solution Prescription TOPICAL AT Dec 26, 2017





9. COSETTE

Cosette Pharmaceuticals Inc has filed for 2 different strengths of generic version for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Cosette.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.025%

cream Prescription TOPICAL AT Nov 5, 2018
0.01%

solution Discontinued TOPICAL N/A Sep 28, 2016


Manufacturing Plant Locations
New

Cosette's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Cosette as present at those locations.

Country City Firm Name
United States
Lincolnton Cosette Pharmaceuticals NC Laboratories, LLC
South Plainfield Cosette Pharmaceuticals, Inc.





10. ENCUBE ETHICALS

Encube Ethicals Pvt Ltd has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Encube Ethicals.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

solution Prescription TOPICAL AT Feb 13, 2019


Manufacturing Plant Locations
New

Encube Ethicals's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Encube Ethicals as present at those locations.

Country City Firm Name
India
Ponda Encube Ethicals Pvt. Ltd.
Andheri East, Mumbai Encube Ethicals Private Ltd





11. FOUGERA PHARMS INC

Fougera Pharmaceuticals Inc has filed for 2 different strengths of generic version for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Fougera Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

solution Prescription TOPICAL AT Dec 16, 1982
0.025%

cream Prescription TOPICAL AT Dec 16, 1982





12. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 1 generic for Fluocinolone Acetonide. This 0.01% version comes by the name FLUOCINONIDE ACETONIDE. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

oil/drops Prescription OTIC AT Dec 14, 2018





13. INVATECH

Invatech Pharma Solutions Llc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Invatech.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.025%

cream Discontinued TOPICAL N/A Dec 16, 1982


Manufacturing Plant Locations
New

Invatech's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Invatech as present at those locations.

Country City Firm Name
United States
East Brunswick InvaTech Pharma Solutions, LLC





14. LUPIN

Lupin Inc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Lupin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

solution Prescription TOPICAL AT Sep 2, 2015


Manufacturing Plant Locations
New

Lupin's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Lupin as present at those locations.

Country City Firm Name
India
Anakapalli District Lupin Manufacturing Solutions Limited
Pithampur Lupin Limited
Mandideep Lupin Limited (Unit II)
Nagpur Lupin Limited
Pithampur Lupin Limited (Unit 1)
Navi Mumbai LUPIN LIMITED
Vasco Da Gama Lupin Limited
Pune Lupin Bioresearch Center
Aurangabad Lupin Ltd.
Tarapur, Thane Lupin Limited
Pirangut Lupin Limited
Dabhasa LUPIN MANUFACTURING SOLUTIONS LIMITED
Mumbai Lupin Limited
Mandideep Lupin Limited
United States
Coral Springs Lupin Research Inc
Baltimore Lupin Pharmaceuticals Inc.





15. NOVEL LABS INC

Novel Laboratories Inc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Novel Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

oil Prescription TOPICAL AT Aug 7, 2023





16. PADAGIS ISRAEL

Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Padagis Israel.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

oil/drops Prescription OTIC AT Jul 17, 2017


Manufacturing Plant Locations
New

Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.

Country City Firm Name
Israel
Yerucham Padagis Israel Pharmaceuticals Ltd.





17. PAI HOLDINGS PHARM

Pai Holdings Llc Dba Pharmaceutical Associates Inc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Pai Holdings Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

solution Discontinued TOPICAL N/A Jan 27, 1984





18. PERRIGO NEW YORK

Perrigo New York Inc has filed for 2 different strengths of generic version for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Perrigo New York.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

cream Discontinued TOPICAL N/A Mar 4, 1982
0.025%

cream Discontinued TOPICAL N/A Mar 4, 1982


Manufacturing Plant Locations
New

Perrigo New York's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Perrigo New York as present at those locations.

Country City Firm Name
United States
Bronx Perrigo New York, Inc.





19. PHARMADERM

Pharmaderm Div Altana Inc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Pharmaderm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.025%

ointment Discontinued TOPICAL N/A Dec 16, 1982





20. PHARMAFAIR

Pharmafair Inc has filed for 2 different strengths of generic version for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Pharmafair.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

cream Discontinued TOPICAL N/A Aug 2, 1984
0.025%

cream Discontinued TOPICAL N/A Aug 2, 1984





21. QUAGEN

Quagen Pharmaceuticals Llc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Quagen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

oil/drops Prescription OTIC AT Apr 2, 2021


Manufacturing Plant Locations
New

Quagen's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Quagen as present at those locations.

Country City Firm Name
United States
West Caldwell Quagen Pharmacuticals, LLC
West Caldwell Quagen Pharma, LLC





22. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

oil Prescription TOPICAL AT Apr 25, 2016


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Livingston Risingsun Iodine Products Corp.
East Brunswick Rising Pharma Holding, Inc.
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Mount Morris Rising Creek Bakery LLC
Phoenix Rising Sun Farms Inc
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
Fort Bragg Rising Tide Sea Vegetables
Rising Sun Rising Sun Veterinary Clinic
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





23. SAVAGE LABS

Savage Laboratories Inc Div Altana Inc has filed for 2 different strengths of generic version for Fluocinolone Acetonide. All of these versions come by the name FLUOTREX. Given below are the details of the strengths of this generic introduced by Savage Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.025%

ointment Discontinued TOPICAL N/A Mar 9, 1983
0.01%

cream Discontinued TOPICAL N/A May 6, 1983





24. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

oil/drops Discontinued OTIC N/A Sep 9, 2016





25. TARO

Taro Pharmaceuticals Inc has filed for 2 different strengths of generic version for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Taro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.025%

cream Discontinued TOPICAL N/A Oct 31, 1994
0.01%

oil Prescription TOPICAL AT May 19, 2016


Manufacturing Plant Locations
New

Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.

Country City Firm Name
United States
Honolulu Taro Delight, LLC
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.





26. TRUPHARMA

Trupharma Llc has filed for 1 generic for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Trupharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.01%

oil/drops Prescription OTIC AT Feb 5, 2021





27. USL PHARMA

Usl Pharma Inc has filed for 2 different strengths of generic version for Fluocinolone Acetonide. Given below are the details of the strengths of this generic introduced by Usl Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.025%

cream Discontinued TOPICAL N/A Mar 28, 1985
0.01%

cream Discontinued TOPICAL N/A Feb 11, 1985