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Fluocinonide Patent Expiration

Fluocinonide is Used for relieving inflammation and itching in dermatological conditions amenable to corticosteroid treatment in patients 12 years and older. It was first introduced by Alvogen Inc in its drug Fluocinonide on Approved Prior to Jan 1, 1982. Other drugs containing Fluocinonide are Lidex-E, Lidex, Vanos. 24 different companies have introduced drugs containing Fluocinonide.


Fluocinonide Patents

Given below is the list of patents protecting Fluocinonide, 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
Vanos US8232264 Compositions and methods for enhancing corticosteroid delivery Mar 09, 2023

(Expired)

 Bausch
Vanos US7220424 Compositions and methods for enhancing corticosteroid delivery Jan 07, 2023

(Expired)

 Bausch
Vanos US7794738 Compositions and methods for enhancing corticosteroid delivery Sep 11, 2022

(Expired)

 Bausch
Vanos US6765001 Compositions and methods for enhancing corticosteroid delivery Dec 21, 2021

(Expired)

 Bausch



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 Fluocinonide's patents.

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

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed
Critical
 18 Mar, 2024 US8232264(Litigated)
Expire Patent
Critical
 17 Oct, 2022 US7794738(Litigated)
Maintenance Fee Reminder Mailed
Critical
 02 May, 2022 US7794738(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 02 Jan, 2020 US8232264(Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 30 Oct, 2018 US7220424(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 21 Feb, 2018 US7794738(Litigated)
Patent Issue Date Used in PTA Calculation
Critical
 31 Jul, 2012 US8232264(Litigated)
Recordation of Patent Grant Mailed
Critical
 31 Jul, 2012 US8232264(Litigated)
Email Notification
Critical
 12 Jul, 2012 US8232264(Litigated)
Issue Notification Mailed
Critical
 11 Jul, 2012 US8232264(Litigated)


Fluocinonide's Family Patents

Family Patents

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Fluocinonide Generic API Manufacturers

Several generic applications have been filed for Fluocinonide. The first generic version for Fluocinonide was by Taro Pharmaceuticals Inc and was approved on Jun 10, 1987. And the latest generic version is by Quagen Pharmaceuticals Llc and was approved on Feb 26, 2025.

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


1. AMNEAL

Amneal Pharmaceuticals Llc has filed for 2 different strengths of generic version for Fluocinonide. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1%

cream Discontinued TOPICAL N/A Jun 4, 2018
0.05%

(reference standard)

cream Prescription TOPICAL AB1 Aug 21, 2018


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





2. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Fluocinonide. 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
0.05%

solution Prescription TOPICAL AT Apr 23, 2018





3. COSETTE

Cosette Pharmaceuticals Inc has filed for 1 generic for Fluocinonide. This 0.05% version comes by the name FLUOCINONIDE EMULSIFIED BASE. Given below are the details of the strengths of this generic introduced by Cosette.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

cream Prescription TOPICAL AB2 Jun 13, 1995


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.





4. ENCUBE

Encube Ethicals Private Ltd has filed for 1 generic for Fluocinonide. Given below are the details of the strengths of this generic introduced by Encube.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

cream Prescription TOPICAL AB1 Oct 16, 2018


Manufacturing Plant Locations
New

Encube'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 as present at those locations.

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





5. ENCUBE ETHICALS

Encube Ethicals Pvt Ltd has filed for 1 generic for Fluocinonide. 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
0.05%

solution Prescription TOPICAL AT Nov 29, 2018


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
Andheri East, Mumbai Encube Ethicals Private Ltd
Ponda Encube Ethicals Pvt. Ltd.





6. FOUGERA PHARMS

Fougera Pharmaceuticals Inc has filed for 1 generic for Fluocinonide. This 0.05% version comes by the name FLUOCINONIDE EMULSIFIED BASE. Given below are the details of the strengths of this generic introduced by Fougera Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

cream Prescription TOPICAL AB2 Jun 23, 2004





7. FOUGERA PHARMS INC

Fougera Pharmaceuticals Inc has filed for 2 different strengths of generic version for Fluocinonide. 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
0.05%

solution Prescription TOPICAL AT Feb 27, 1995
0.1%

cream Prescription TOPICAL AB Jul 14, 2014





8. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 1 generic for Fluocinonide. 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
0.1%

cream Prescription TOPICAL AB Jul 14, 2014





9. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 1 generic for Fluocinonide. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

solution Prescription TOPICAL AT Apr 23, 2018





10. NOVEL LABS INC

Novel Laboratories Inc has filed for 1 generic for Fluocinonide. 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
0.05%

solution Prescription TOPICAL AT Jul 21, 2017





11. PADAGIS ISRAEL

Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Fluocinonide. 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
0.1%

cream Discontinued TOPICAL N/A Jan 14, 2014


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.





12. PADAGIS US

Padagis Us Llc has filed for 1 generic for Fluocinonide. Given below are the details of the strengths of this generic introduced by Padagis Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

gel Prescription TOPICAL AB Jun 19, 2018


Manufacturing Plant Locations
New

Padagis Us'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 Padagis Us as present at those locations.

Country City Firm Name
United States
Minneapolis Padagis US LLC





13. PAI HOLDINGS PHARM

Pai Holdings Llc Dba Pharmaceutical Associates Inc has filed for 2 different strengths of generic version for Fluocinonide. 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
0.05%

ointment Discontinued TOPICAL N/A Sep 28, 2018
0.1%

cream Discontinued TOPICAL N/A Apr 3, 2019





14. PERRIGO NEW YORK

Perrigo New York Inc has filed for 1 generic for Fluocinonide. 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
0.05%

cream Discontinued TOPICAL N/A Jul 13, 1988


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.





15. QUAGEN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

solution Prescription TOPICAL AT Feb 26, 2025


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 Pharma, LLC
West Caldwell Quagen Pharmacuticals, LLC





16. SAPTALIS PHARMS

Saptalis Pharmaceuticals Llc has filed for 1 generic for Fluocinonide. Given below are the details of the strengths of this generic introduced by Saptalis Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

solution Discontinued TOPICAL N/A Mar 18, 2019





17. TARO

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

(reference standard)

ointment Prescription TOPICAL AB Jun 30, 1999
0.1%

cream Prescription TOPICAL AB Jul 14, 2014


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.





18. TEVA

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Fluocinonide. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

ointment Prescription TOPICAL AB Dec 27, 1991


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Miami Teva Branded Pharmaceutical Products R & D, Inc.
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Horsham Teva Branded Pharmaceutical Products R&D
Fort Dodge TEVA Animal Health Inc
India
Bhind Teva API India Ltd- Malanpur
Gajraula, Amroha Teva API India Private Ltd.
Canada
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Markham Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





19. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 1 generic for Fluocinonide. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

solution Discontinued TOPICAL N/A Sep 28, 1990





20. XIROMED

Xiromed Pharma Espana Sl has filed for 1 generic for Fluocinonide. Given below are the details of the strengths of this generic introduced by Xiromed.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

ointment Prescription TOPICAL AB Nov 26, 2019


Manufacturing Plant Locations
New

Xiromed'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 Xiromed as present at those locations.

Country City Firm Name
United States
Florham Park XIROMED LLC





21. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 1 generic for Fluocinonide. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1%

cream Prescription TOPICAL AB Feb 10, 2020


Manufacturing Plant Locations
New

Zydus Lifesciences'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 Zydus Lifesciences as present at those locations.

Country City Firm Name
India
Matoda Zydus Lifesciences Limited
District Solan Zydus Lifesciences Limited
Ankleshwar Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited
Ahmedabad Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Moraiya, Ahmedabad Zydus Lifesciences Limited
Jarod Zydus Lifesciences Limited





22. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Fluocinonide. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

solution Prescription TOPICAL AT Jul 17, 2018