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 Temovate E, Impoyz, Clobetasol Propionate, Clobex, Impeklo, Olux, Olux E. 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 05 Jul, 2022 US11376262
Recordation of Patent Grant Mailed 05 Jul, 2022 US11376262
Email Notification 16 Jun, 2022 US11376262
Issue Notification Mailed 15 Jun, 2022 US11376262
Application Is Considered Ready for Issue 25 May, 2022 US11376262
Dispatch to FDC 25 May, 2022 US11376262
Issue Fee Payment Received 20 May, 2022 US11376262
Issue Fee Payment Verified 08 May, 2022 US11376262
Mail Response to 312 Amendment (PTO-271) 08 Apr, 2022 US11376262


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Family Patents

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Clobetasol Propionate Generics

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.


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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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