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Clobetasol Propionate Patent Expiration

Clobetasol Propionate is Used for treating skin diseases using a corticosteroid-containing pharmaceutical composition. It was first introduced by Fougera Pharmaceuticals Inc in its drug Temovate on Dec 27, 1985. Other drugs containing Clobetasol Propionate are Impoyz, Temovate E, Clobex, Impeklo, Olux E, Clobetasol Propionate, Olux. 40 different companies have introduced drugs containing Clobetasol Propionate.


Clobetasol Propionate Patents

Given below is the list of patents protecting Clobetasol Propionate, 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
Clobetasol Propionate US10588913 Aqueous suspension agent containing glucocorticosteroid nanoparticles May 09, 2036 Eyenovia
Clobetasol Propionate US11376262 Method of treating an inflammatory or infectious disease May 09, 2036 Eyenovia
Impoyz US9855334 Topical compositions comprising a corticosteroid Mar 11, 2035 Primus Pharms
Impoyz US10064875 Topical formulations comprising a steroid Aug 31, 2030 Primus Pharms
Impoyz US10588914 Topical formulations comprising a steroid Aug 31, 2030 Primus Pharms
Impoyz US9956231 Topical formulations comprising a steroid Aug 31, 2030 Primus Pharms
Olux E US8460641 Microemulsion process and composition Nov 05, 2028 Norvium Bioscience
Olux E US8962000 Microemulsion and sub-micron emulsion process and compositions Aug 31, 2025 Norvium Bioscience
Clobex US7700081 Foaming compositions for hair care Jan 03, 2022

(Expired)

 Galderma Labs
Olux E US6730288 Mousse composition Sep 08, 2019

(Expired)

 Norvium Bioscience
Olux E US7029659 Mousse composition Sep 08, 2019

(Expired)

 Norvium Bioscience
Clobex US7316810 Foaming composition for washing and treating hair and/or scalp based on an active principle Jun 17, 2019

(Expired)

 Galderma Labs
Clobex US8066975 Foaming composition for washing and treating hair and/or scalp based on an active principle Jun 17, 2019

(Expired)

 Galderma Labs
Clobex US8066976 Foaming compositions for hair care Jun 17, 2019

(Expired)

 Galderma Labs
Clobex US5990100 Composition and method for treatment of psoriasis Mar 24, 2018

(Expired)

 Galderma Labs Lp
Clobex US5972920 Formulation containing a carrier, active ingredient, and surfactant for treating skin disorders Feb 12, 2018

(Expired)

 Galderma Labs Lp
Clobex US6106848 Topically applicable O/W emulsions having high glycol content and at least one biologically active agent Sep 22, 2017

(Expired)

 Galderma Labs Lp
Olux US6126920 Method of treating a skin disease with a corticosteroid-containing pharmaceutical composition Mar 01, 2016

(Expired)

 Norvium Bioscience



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 Clobetasol Propionate's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 17 Mar, 2023 US10588913
Patent Issue Date Used in PTA Calculation
Critical
 05 Jul, 2022 US11376262
Recordation of Patent Grant Mailed
Critical
 05 Jul, 2022 US11376262
Email Notification
Critical
 16 Jun, 2022 US11376262
Issue Notification Mailed
Critical
 15 Jun, 2022 US11376262
Application Is Considered Ready for Issue
Critical
 25 May, 2022 US11376262
Dispatch to FDC 25 May, 2022 US11376262
Issue Fee Payment Received
Critical
 20 May, 2022 US11376262
Issue Fee Payment Verified
Critical
 08 May, 2022 US11376262
Mail Response to 312 Amendment (PTO-271)
Critical
 08 Apr, 2022 US11376262


Clobetasol Propionate's Family Patents

Family Patents

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Clobetasol Propionate Generic API Manufacturers

Several generic applications have been filed for Clobetasol Propionate. The first generic version for Clobetasol Propionate was by Cosette Pharmaceuticals Inc and was approved on Feb 16, 1994. And the latest generic version is by Taro Pharmaceutical Industries Ltd and was approved on Mar 14, 2024.

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


1. ACTAVIS MID ATLANTIC

Actavis Mid Atlantic Llc has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Actavis Mid Atlantic.

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

shampoo Discontinued TOPICAL N/A Jun 7, 2011





2. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Alembic.

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

aerosol, foam Prescription TOPICAL AB1 Apr 21, 2022


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited





3. AMNEAL

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

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

shampoo Prescription TOPICAL AB Jun 14, 2021


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





4. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 1 generic for Clobetasol Propionate. This 0.05% version comes by the name CLOBETASOL PROPIONATE (EMOLLIENT). Given below are the details of the strengths of this generic introduced by Ani Pharms.

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

cream Discontinued TOPICAL N/A Aug 22, 2001





5. APOTEX

Apotex Inc has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Apotex.

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

spray Discontinued TOPICAL N/A Apr 17, 2018


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Toronto Apotex Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Etobicoke Apotex, Inc.
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
India
Bengaluru Apotex Research Private Limited
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bangalore Apotex Pharmachem India Pvt Ltd.





6. AUROBINDO PHARMA USA

Aurobindo Pharma Usa Inc has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Usa.

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

cream Prescription TOPICAL AB1 Feb 9, 2001


Manufacturing Plant Locations
New

Aurobindo Pharma Usa'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 Aurobindo Pharma Usa as present at those locations.

Country City Firm Name
United States
East Windsor Aurobindo Pharma USA Inc





7. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Clobetasol Propionate. 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%

cream Discontinued TOPICAL N/A Mar 26, 2021





8. COSETTE

Cosette Pharmaceuticals Inc has filed for 1 generic for Clobetasol Propionate. 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%

solution Discontinued TOPICAL N/A Dec 15, 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.





9. ENCUBE

Encube Ethicals Private Ltd has filed for 1 generic for Clobetasol Propionate. 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%

(reference standard)

cream Prescription TOPICAL AB1 Aug 28, 2020


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.





10. EPIC PHARMA LLC

Epic Pharma Llc has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

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

lotion Discontinued TOPICAL N/A Oct 26, 2018





11. FOUGERA PHARMS

Fougera Pharmaceuticals Inc has filed for 1 generic for Clobetasol Propionate. 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%

(reference standard)

gel Prescription TOPICAL AB Feb 15, 2000





12. FOUGERA PHARMS INC

Fougera Pharmaceuticals Inc has filed for 1 generic for Clobetasol Propionate. 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%

cream Prescription TOPICAL AB1 Sep 30, 1996





13. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 1 generic for Clobetasol Propionate. 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
0.05%

aerosol, foam Prescription TOPICAL AB2 Sep 9, 2019





14. GLENMARK SPECLT

Glenmark Specialty Sa has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Glenmark Speclt.

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

cream Prescription TOPICAL AB1 May 10, 2018





15. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Hikma.

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

shampoo Discontinued TOPICAL N/A Oct 27, 2017


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





16. LUPIN LTD

Lupin Ltd has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

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

spray Prescription TOPICAL AT Mar 26, 2018


Manufacturing Plant Locations
New

Lupin Ltd'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 Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





17. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 1 generic for Clobetasol Propionate. 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%

ointment Prescription TOPICAL AB Dec 28, 2023





18. NOVAST LABS

Novast Laboratories Inc has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Novast Labs.

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

aerosol, foam Discontinued TOPICAL N/A Jul 31, 2017





19. NOVEL LABS INC

Novel Laboratories Inc has filed for 1 generic for Clobetasol Propionate. 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%

ointment Prescription TOPICAL AB May 4, 2018





20. PADAGIS ISRAEL

Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Clobetasol Propionate. 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
0.05%

(reference standard)

aerosol, foam Prescription TOPICAL AB2 Aug 14, 2012


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.





21. PADAGIS US

Padagis Us Llc has filed for 1 generic for Clobetasol Propionate. 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%

spray Prescription TOPICAL AT Jun 16, 2011


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





22. PAI HOLDINGS PHARM

Pai Holdings Llc Dba Pharmaceutical Associates Inc has filed for 1 generic for Clobetasol Propionate. 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 Jan 23, 2019





23. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Prinston Inc.

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

solution Discontinued TOPICAL N/A Feb 8, 2021





24. QUAGEN

Quagen Pharmaceuticals Llc has filed for 1 generic for Clobetasol Propionate. 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 17, 2022


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





25. RISING

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

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

cream Prescription TOPICAL AB1 Jan 11, 2019


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





26. SAPTALIS PHARMS

Saptalis Pharmaceuticals Llc has filed for 1 generic for Clobetasol Propionate. 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 Prescription TOPICAL AT Oct 2, 2019





27. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 1 generic for Clobetasol Propionate. 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
0.05%

spray Discontinued TOPICAL N/A Apr 28, 2017





28. TARO

Taro Pharmaceutical Industries Ltd has filed for 1 generic for Clobetasol Propionate. 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%

aerosol, foam Prescription TOPICAL AB2 Mar 14, 2024


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
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Honolulu Taro Delight, LLC
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.





29. TEVA PHARMS USA

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

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

cream Discontinued TOPICAL N/A Feb 16, 1994





30. TORRENT

Torrent Pharmaceuticals Ltd has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Torrent.

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

cream Discontinued TOPICAL N/A Dec 30, 2019


Manufacturing Plant Locations
New

Torrent'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 Torrent as present at those locations.

Country City Firm Name
India
Gandhi Nagar Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
Bharuch Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
United States
Kalamazoo Torrent Pharma Inc.
Basking Ridge Torrent Pharma Inc.





31. WOCKHARDT BIO AG

Wockhardt Bio Ag has filed for 1 generic for Clobetasol Propionate. Given below are the details of the strengths of this generic introduced by Wockhardt Bio Ag.

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

solution Discontinued TOPICAL N/A Nov 13, 1998





32. XIROMED

Xiromed Pharma Espana Sl has filed for 1 generic for Clobetasol Propionate. 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%

cream Prescription TOPICAL AB1 Jun 15, 2018


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





33. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 1 generic for Clobetasol Propionate. 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
0.05%

lotion Prescription TOPICAL AB Sep 24, 2019


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
Ankleshwar Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Ahmedabad Zydus Lifesciences Limited
Matoda Zydus Lifesciences Limited
Jarod Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
District Solan Zydus Lifesciences Limited





34. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Clobetasol Propionate. 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%

cream Prescription TOPICAL AB1 Oct 15, 2018





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