Vyalev is a drug owned by Abbvie Inc. It is protected by 3 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 Oct 21, 2035. Details of Vyalev's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9446059 | Carbidopa and L-dopa prodrugs and methods of use |
Oct, 2035
(10 years from now) | Active |
| US10730895 | Carbidopa prodrug |
Oct, 2035
(10 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10174061 | Carbidopa and L-dopa prodrugs and methods of use |
Oct, 2035
(10 years from now) | Active |
FDA has granted several exclusivities to Vyalev. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vyalev, 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 Vyalev.
Exclusivity Information
Vyalev holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Vyalev's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 16, 2027 |
US patents provide insights into the exclusivity only within the United States, but Vyalev 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 Vyalev's family patents as well as insights into ongoing legal events on those patents.
Vyalev's Family Patents
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Generic Launch
Generic Release Date:
Vyalev's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 21, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vyalev Generics:
There are no approved generic versions for Vyalev as of now.
About Vyalev
Vyalev is a drug owned by Abbvie Inc. Vyalev uses Foscarbidopa; Foslevodopa as an active ingredient. Vyalev was launched by Abbvie in 2024.
Approval Date:
Vyalev was approved by FDA for market use on 16 October, 2024.
Active Ingredient:
Vyalev uses Foscarbidopa; Foslevodopa as the active ingredient. Check out other Drugs and Companies using Foscarbidopa; Foslevodopa ingredient
Dosage:
Vyalev is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |