Zokinvy is a drug owned by Sentynl Therapeutics Inc. It is protected by 2 US drug patents filed in 2021 out of which none have expired yet. Zokinvy's patents have been open to challenges since 20 November, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 26, 2029. Details of Zokinvy'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). | |||
| US7838531 | Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis |
Jul, 2029
(4 years from now) | Active |
| US8828356 | Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis |
Oct, 2025
(3 months 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 Zokinvy's patents.
Latest Legal Activities on Zokinvy's Patents
Given below is the list of recent legal activities going on the following patents of Zokinvy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Requirement for information sent under 37 CFR 1.750 | 08 Jul, 2024 | US7838531 |
| Letter from FDA or Dept of Agriculture re PTE application | 18 Jan, 2024 | US7838531 |
| transaction for FDA Determination of Regulatory Review Period | 27 Dec, 2023 | US7838531 |
| Second letter to regulating agency to determine regulatory review period | 10 Mar, 2023 | US7838531 |
| Letter from FDA or Dept of Agriculture re PTE application | 09 Nov, 2022 | US7838531 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Apr, 2022 | US7838531 |
| Initial letter Re: PTE Application to regulating agency | 23 Feb, 2022 | US7838531 |
| Patent Term Extension Application under 35 USC 156 Filed | 14 Jan, 2021 | US7838531 |
| Email Notification Critical | 11 Jan, 2021 | US7838531 |
| Change in Power of Attorney (May Include Associate POA) Critical | 11 Jan, 2021 | US7838531 |
FDA has granted several exclusivities to Zokinvy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zokinvy, 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 Zokinvy.
Exclusivity Information
Zokinvy holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Zokinvy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 20, 2025 |
| Orphan Drug Exclusivity(ODE-324) | Nov 20, 2027 |
US patents provide insights into the exclusivity only within the United States, but Zokinvy 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 Zokinvy's family patents as well as insights into ongoing legal events on those patents.
Zokinvy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zokinvy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 26, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zokinvy Generics:
There are no approved generic versions for Zokinvy as of now.
About Zokinvy
Zokinvy is a drug owned by Sentynl Therapeutics Inc. It is used for reducing the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS). Zokinvy uses Lonafarnib as an active ingredient. Zokinvy was launched by Sentynl Theraps Inc in 2020.
Approval Date:
Zokinvy was approved by FDA for market use on 20 November, 2020.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Zokinvy is 20 November, 2020, its NCE-1 date is estimated to be 20 November, 2024.
Active Ingredient:
Zokinvy uses Lonafarnib as the active ingredient. Check out other Drugs and Companies using Lonafarnib ingredient
Treatment:
Zokinvy is used for reducing the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS).
Dosage:
Zokinvy is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG | CAPSULE | Prescription | ORAL |
| 75MG | CAPSULE | Prescription | ORAL |