Temodar is a drug owned by Merck Sharp And Dohme Corp. It is protected by 5 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 08, 2023. Details of Temodar'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).
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 Temodar's patents.
Latest Legal Activities on Temodar's Patents
Given below is the list of recent legal activities going on the following
patents of Temodar.
FDA has granted several exclusivities to Temodar. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Temodar, 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
Temodar.
Exclusivity Information
Temodar holds 1 exclusivities. All of its exclusivities have expired in 2012.
Details of Temodar's exclusivity codes and their expiration dates are given
below.
Drug Exclusivity
Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE)
Mar 15, 2012
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Several oppositions have been filed on Temodar'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 Temodar's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Temodar patents.
Temodar's
Oppositions Filed in EPO
Temodar has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 04, 2009, by Chemagis Ltd.. This opposition was filed on patent number EP03709188A. Click below to
reveal the latest
opposition data.
Application
Filing Date
Opposition Party
Legal Status
EP03709188A
Mar, 2009
CHEMAGIS LTD.
Opposition rejected
US patents provide insights into the exclusivity only within the United States, but
Temodar 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 Temodar's family patents as well as insights into
ongoing legal events
on those patents.
Temodar's Family Patents
Temodar has
patent protection in a total of 23 countries. It's US patent count contributes only to 28.2% of its total global patent coverage. 9 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 Temodar.
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Clinical Trials
Recent Clinical Trials on Temodar:
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.
Temodar's
generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 08, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Temodar Generic
API
suppliers:
Temozolomide is the generic name
for
the brand Temodar.
17 different companies have already filed for the generic of Temodar, with Zydus Pharms having the maximum number of approved applications.
Check out the entire list of companies
who have already received approval for Temodar's
generic
How can I launch a generic of Temodar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before
the expiration of Temodar's patents related
by providing a 'paragraph IV certification' in your
application, which states that the patent submitted by the
Temodar'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 Temodar -
Temodar is a drug owned by Merck Sharp And Dohme Corp. It is used for treating malignant neoplasms. Temodar uses Temozolomide as an active ingredient. Temodar was launched by Merck in 2009.
Approval Date:
Temodar was approved by
FDA for market
use on 27 February, 2009.
Temodar
is available in the following dosage forms - capsule form for oral use, powder form for intravenous use. Given below is detailed information on Dosage -
