Acetaminophen is a drug owned by Fresenius Kabi Usa Llc. It is protected by 1 US drug patent filed in 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 19, 2030. Details of Acetaminophen's patents and their expiration are given in the table below.
Patent strength
4
/ 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).
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 Acetaminophen's patents.
Latest Legal Activities on Acetaminophen's Patents
Given below is the list of recent legal activities going on the following
patents of Acetaminophen.
Activity
Date
Patent Number
Payment of Maintenance Fee, 12th Year, Large Entity
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Several oppositions have been filed on Acetaminophen'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 Acetaminophen's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Acetaminophen patents.
Acetaminophen's
Oppositions Filed in EPO
Acetaminophen has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 19, 2013, by Wibbelmann, Jobst. This opposition was filed on patent number EP10714862A. Click below to
reveal the latest
opposition data.
Application
Filing Date
Opposition Party
Legal Status
EP10714862A
Dec, 2013
Wibbelmann, Jobst
Opposition rejected
US patents provide insights into the exclusivity only within the United States, but
Acetaminophen 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 Acetaminophen's family patents as well as insights into
ongoing legal events
on those patents.
Acetaminophen's Family Patents
Acetaminophen has
patent protection in a total of 12 countries. It's US patent count contributes only to 15.0% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Acetaminophen.
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Recently Granted Patents in EP
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Clinical Trials
Recent Clinical Trials on Acetaminophen:
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.
Acetaminophen's
generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 19, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Acetaminophen Generic
API
suppliers:
Acetaminophen is the generic name
for
the brand Acetaminophen.
22 different companies have already filed for the generic of Acetaminophen, with Cosette Pharms Nc having the maximum number of approved applications.
Check out the entire list of companies
who have already received approval for Acetaminophen's
generic
Alternative Brands for
Acetaminophen
There are several other brand drugs using the same active ingredient (Acetaminophen) as 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.
Acetaminophen is a drug owned by Fresenius Kabi Usa Llc. Acetaminophen uses Acetaminophen as an active ingredient. Acetaminophen was launched by Fresenius Kabi in 2015.
Approval Date:
Acetaminophen was approved by
FDA for market
use on 28 October, 2015.
