Clobetasol Propionate Patent Expiration

Clobetasol Propionate is a drug owned by Eyenovia Inc. It is protected by 2 US drug patents filed in 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 09, 2036. Details of Clobetasol Propionate's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11376262 Method of treating an inflammatory or infectious disease
May, 2036

(11 years from now)

Active
US10588913 Aqueous suspension agent containing glucocorticosteroid nanoparticles
May, 2036

(11 years from now)

Active


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 of 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


FDA has granted several exclusivities to Clobetasol Propionate. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Clobetasol Propionate, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Clobetasol Propionate.

Exclusivity Information

Clobetasol Propionate holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Clobetasol Propionate's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Mar 04, 2027

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US patents provide insights into the exclusivity only within the United States, but Clobetasol Propionate is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Clobetasol Propionate's family patents as well as insights into ongoing legal events on those patents.

Clobetasol Propionate's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Clobetasol Propionate's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 09, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Clobetasol Propionate Generic API suppliers:

Clobetasol Propionate is the generic name for the brand Clobetasol Propionate. 35 different companies have already filed for the generic of Clobetasol Propionate, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Clobetasol Propionate's generic

Alternative Brands for Clobetasol Propionate

Clobetasol Propionate which is used for treating inflammation., has several other brand drugs using the same active ingredient (Clobetasol Propionate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Galderma Labs
Clobex
Galderma Labs Lp
Clobex
Norvium Bioscience
Olux
Olux E
Primus Pharms
Impoyz


Apart from brand drugs containing the same ingredient, some generics have also been filed for Clobetasol Propionate, Clobetasol Propionate's active ingredient. Check the complete list of approved generic manufacturers for Clobetasol Propionate





About Clobetasol Propionate

Clobetasol Propionate is a drug owned by Eyenovia Inc. It is used for treating inflammation. Clobetasol Propionate uses Clobetasol Propionate as an active ingredient. Clobetasol Propionate was launched by Eyenovia in 2024.

Approval Date:

Clobetasol Propionate was approved by FDA for market use on 04 March, 2024.

Active Ingredient:

Clobetasol Propionate uses Clobetasol Propionate as the active ingredient. Check out other Drugs and Companies using Clobetasol Propionate ingredient

Treatment:

Clobetasol Propionate is used for treating inflammation.

Dosage:

Clobetasol Propionate is available in suspension/drops form for ophthalmic use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.05% SUSPENSION/DROPS Prescription OPHTHALMIC