Ofirmev is a drug owned by Mallinckrodt Hosp Products Ip Ltd. It is protected by 12 US drug patents filed from 2013 to 2025. Out of these, 8 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 11, 2032. Details of Ofirmev's patents and their expiration are given in the table below.
Patent strength
3
/ 10
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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).
Stable liquid paracetamol compositions, and method for preparing same
Aug, 2017
(9 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 Ofirmev's patents.
Latest Legal Activities on Ofirmev's Patents
Given below is the list of recent legal activities going on the following
patents of Ofirmev.
Activity
Date
Patent Number
Payment of Maintenance Fee, 8th Year, Large Entity
FDA has granted several exclusivities to Ofirmev. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Ofirmev, 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
Ofirmev.
Exclusivity Information
Ofirmev holds 3 exclusivities. All of its exclusivities have expired in 2020.
Details of Ofirmev's exclusivity codes and their expiration dates are given
below.
Drug Exclusivity
Drug Exclusivity Expiration
New Product(NP)
Nov 02, 2013
M(M-196)
Jan 27, 2020
Pediatric Exclusivity(PED)
Jul 27, 2020
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US patents provide insights into the exclusivity only within the United States, but
Ofirmev 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 Ofirmev's family patents as well as insights into
ongoing legal events
on those patents.
Ofirmev's Family Patents
Ofirmev has
patent protection in a total of 3 countries. It has a significant patent presence in the US with 75.0% of its patents being US patents. Click below to unlock the full patent family tree for Ofirmev.
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Recently Granted Patents in EP
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Clinical Trials
Recent Clinical Trials on Ofirmev:
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.
Ofirmev's
generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 11, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ofirmev Generic
API
suppliers:
Acetaminophen is the generic name
for
the brand Ofirmev.
22 different companies have already filed for the generic of Ofirmev, with Cosette Pharms Nc having the maximum number of approved applications.
Check out the entire list of companies
who have already received approval for Ofirmev's
generic
How can I launch a generic of Ofirmev before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before
the expiration of Ofirmev's patents related
by providing a 'paragraph IV certification' in your
application, which states that the patent submitted by the
Ofirmev'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 Ofirmev -
Ofirmev
which is used for managing mild to severe pain in conjunction with opioid analgesics., has several other brand drugs using the same active ingredient (Acetaminophen).
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.
Ofirmev is a drug owned by Mallinckrodt Hosp Products Ip Ltd. It is used for managing mild to severe pain in conjunction with opioid analgesics. Ofirmev uses Acetaminophen as an active ingredient. Ofirmev was launched by Mallinckrodt in 2010.
Approval Date:
Ofirmev was approved by
FDA for market
use on 02 November, 2010.
