Byqlovi is a drug owned by Formosa Pharmaceuticals 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 Byqlovi'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
(10 years from now) | Active |
| US10588913 | Aqueous suspension agent containing glucocorticosteroid nanoparticles |
May, 2036
(10 years from now) | Active |
FDA has granted several exclusivities to Byqlovi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Byqlovi, 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 Byqlovi.
Exclusivity Information
Byqlovi holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Byqlovi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 04, 2027 |
US patents provide insights into the exclusivity only within the United States, but Byqlovi 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 Byqlovi's family patents as well as insights into ongoing legal events on those patents.
Byqlovi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Byqlovi'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)
Byqlovi Generic API suppliers:
Clobetasol Propionate is the generic name for the brand Byqlovi. 35 different companies have already filed for the generic of Byqlovi, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Byqlovi's generic
Alternative Brands for Byqlovi
There are several other brand drugs using the same active ingredient (Clobetasol Propionate) as Byqlovi. 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 |
| |
| Galderma Labs Lp |
| |
| Norvium Bioscience |
| |
| Pharmobedient |
| |
| Primus Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Clobetasol Propionate, Byqlovi's active ingredient. Check the complete list of approved generic manufacturers for Byqlovi
About Byqlovi
Byqlovi is a drug owned by Formosa Pharmaceuticals Inc. Byqlovi uses Clobetasol Propionate as an active ingredient. Byqlovi was launched by Formosa in 2024.
Approval Date:
Byqlovi was approved by FDA for market use on 04 March, 2024.
Active Ingredient:
Byqlovi uses Clobetasol Propionate as the active ingredient. Check out other Drugs and Companies using Clobetasol Propionate ingredient
Dosage:
Byqlovi 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 |