Verzenio is a drug owned by Eli Lilly And Co. It is protected by 1 US drug patent filed in 2018 out of which none have expired yet. Verzenio's patents have been open to challenges since 28 September, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 28, 2031. Details of Verzenio'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. | |||
| US7855211 | Protein kinase inhibitors |
Sep, 2031
(6 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 Verzenio's patents.
Latest Legal Activities on Verzenio's Patents
Given below is the list of recent legal activities going on the following patents of Verzenio.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Notice of Final Determination -Eligible | 15 Dec, 2023 | US7855211 |
| FDA Final Eligibility Letter Critical | 14 Nov, 2023 | US7855211 |
| transaction for FDA Determination of Regulatory Review Period | 01 Mar, 2023 | US7855211 |
| transaction for FDA Determination of Regulatory Review Period | 18 Jan, 2023 | US7855211 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 May, 2022 | US7855211 |
| Second letter to regulating agency to determine regulatory review period | 26 Mar, 2021 | US7855211 |
| Electronic Review Critical | 26 Jun, 2020 | US7855211 |
| Email Notification Critical | 24 Jun, 2020 | US7855211 |
| Mail Certificate of Correction Memo | 23 Jun, 2020 | US7855211 |
| Post Issue Communication - Certificate of Correction | 19 Jun, 2020 | US7855211 |
FDA has granted several exclusivities to Verzenio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Verzenio, 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 Verzenio.
Exclusivity Information
Verzenio holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Verzenio's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-768) | Feb 26, 2021 |
| New Chemical Entity Exclusivity(NCE) | Sep 28, 2022 |
| New Indication(I-877) | Oct 12, 2024 |
| New Patient Population(NPP) | Oct 12, 2024 |
US patents provide insights into the exclusivity only within the United States, but Verzenio 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 Verzenio's family patents as well as insights into ongoing legal events on those patents.
Verzenio's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Verzenio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 28, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Verzenio Generics:
There are no approved generic versions for Verzenio as of now.
About Verzenio
Verzenio is a drug owned by Eli Lilly And Co. It is used for treating HR-positive, HER2-negative advanced or metastatic breast cancer in various settings. Verzenio uses Abemaciclib as an active ingredient. Verzenio was launched by Eli Lilly And Co in 2017.
Approval Date:
Verzenio was approved by FDA for market use on 28 September, 2017.
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 Verzenio is 28 September, 2017, its NCE-1 date is estimated to be 28 September, 2021.
Active Ingredient:
Verzenio uses Abemaciclib as the active ingredient. Check out other Drugs and Companies using Abemaciclib ingredient
Treatment:
Verzenio is used for treating HR-positive, HER2-negative advanced or metastatic breast cancer in various settings.
Dosage:
Verzenio is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |
| 150MG | TABLET | Prescription | ORAL |