Velcade is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 11 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 25, 2022. Details of Velcade'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 focus on the other aspects of the drug like dosage, mode of administration
(oral, tablet,
capsules, liquids etc).
Boronic ester and acid compounds, synthesis and uses
Oct, 2014
(11 years ago)
Expired
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 Velcade's patents.
Latest Legal Activities on Velcade's Patents
Given below is the list of recent legal activities going on the following
patents of Velcade.
FDA has granted several exclusivities to Velcade. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Velcade, 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
Velcade.
Exclusivity Information
Velcade holds 9 exclusivities. All of its exclusivities have expired in 2022.
Details of Velcade's exclusivity codes and their expiration dates are given
below.
Drug Exclusivity
Drug Exclusivity Expiration
NR(NR)
Jan 23, 2015
M(M-139)
Aug 08, 2017
New Dosing Schedule(D-141)
Oct 08, 2017
New Dosing Schedule(D-142)
Oct 08, 2017
New Indication(I-695)
Oct 08, 2017
M(M-165)
Sep 14, 2018
Orphan Drug Exclusivity(ODE)
Oct 08, 2021
Orphan Drug Exclusivity(ODE-76)
Oct 08, 2021
Pediatric Exclusivity(PED)
Apr 08, 2022
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Several oppositions have been filed on Velcade's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Velcade's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Velcade patents.
Velcade's
Oppositions Filed in EPO
Velcade has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 08, 2011, by Hameln Rds Gmbh. This opposition was filed on patent number EP02709145A. Click below to
reveal the latest
opposition data.
US patents provide insights into the exclusivity only within the United States, but
Velcade 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 Velcade's family patents as well as insights into
ongoing legal events
on those patents.
Velcade's Family Patents
Velcade has
patent protection in a total of 13 countries. It's US patent count contributes only to 27.3% of its total global patent coverage. 11 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 Velcade.
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Clinical Trials
Recent Clinical Trials on Velcade:
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.
Velcade's
generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 25, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Velcade Generic
API
suppliers:
Bortezomib is the generic name
for
the brand Velcade.
22 different companies have already filed for the generic of Velcade, with Gland having the maximum number of approved applications.
Check out the entire list of companies
who have already received approval for Velcade's
generic
How can I launch a generic of Velcade before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before
the expiration of Velcade's patents related
by providing a 'paragraph IV certification' in your
application, which states that the patent submitted by the
Velcade'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 Velcade -
Velcade
which is used for treating multiple myeloma patients who have not responded to previous therapies., has several other brand drugs using the same active ingredient (Bortezomib).
Given below is the list of those companies and their brand drugs, to help you identify new
opportunities, assess
competitors, and plan your market strategies more effectively.
Velcade is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating multiple myeloma patients who have not responded to previous therapies. Velcade uses Bortezomib as an active ingredient. Velcade was launched by Takeda in 2003.
Approval Date:
Velcade was approved by
FDA for market
use on 13 May, 2003.
