Vyalev is a drug owned by Abbvie Inc. It is protected by 4 US drug patents filed from 2024 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 10, 2040. 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
(9 years from now) | Active |
| US10730895 | Carbidopa prodrug |
Oct, 2035
(9 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). | |||
| US12251365 | Pharmaceutical formulations for subcutaneous administration |
Jun, 2040
(14 years from now) | Active |
| US10174061 | Carbidopa and L-dopa prodrugs and methods of use |
Oct, 2035
(9 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 Vyalev's patents.
Latest Legal Activities on Vyalev's Patents
Given below is the list of recent legal activities going on the following patents of Vyalev.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Letter from FDA or Dept of Agriculture re PTE application | 23 Sep, 2025 | US9446059 |
| Information Disclosure Statement (IDS) Filed | 23 Sep, 2025 | US9446059 |
| Letter from FDA or Dept of Agriculture re PTE application | 23 Sep, 2025 | US10730895 |
| Letter from FDA or Dept of Agriculture re PTE application | 23 Sep, 2025 | US10174061 |
| Mail Patent eCofC Notification | 15 Apr, 2025 | US12251365 |
| Patent eCofC Notification | 15 Apr, 2025 | US12251365 |
| Email Notification | 15 Apr, 2025 | US12251365 |
| Recordation of Patent eCertificate of Correction | 15 Apr, 2025 | US12251365 |
| Email Notification | 18 Mar, 2025 | US12251365 |
| Patent eGrant Notification | 18 Mar, 2025 | US12251365 |
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
Explore Our Curated Drug Screens
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 Jun 10, 2040 (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 |