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.
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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.
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.
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
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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
Verzenio has
patent protection in a total of 45 countries. It's US patent count contributes only to 8.2% of its total global patent coverage. 8 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Verzenio.
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Recently Granted Patents in EP
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Clinical Trials
Recent Clinical Trials on Verzenio:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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.
How can I launch a generic of Verzenio before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before
the expiration of Verzenio's patents related
by providing a 'paragraph IV certification' in your
application, which states that the patent submitted by the
Verzenio's sponsor is invalid, unenforceable,
or will not be infringed by your generic product.
Given below are the details of the already filed Para IV
certificates on 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 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.
