Fulvestrant is a drug owned by Fresenius Kabi Usa Llc. It is protected by 3 US drug patents filed in 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 17, 2034. Details of Fulvestrant's patents and their expiration are given in the table below.
Patent strength
5
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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 Fulvestrant's patents.
Latest Legal Activities on Fulvestrant's Patents
Given below is the list of recent legal activities going on the following
patents of Fulvestrant.
Activity
Date
Patent Number
Payment of Maintenance Fee, 8th Year, Large Entity
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US patents provide insights into the exclusivity only within the United States, but
Fulvestrant 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 Fulvestrant's family patents as well as insights into
ongoing legal events
on those patents.
Fulvestrant's Family Patents
Fulvestrant has
patent protection in a total of 1 countries. It has a significant patent presence in the US with 100.0% of its patents being US patents. Click below to unlock the full patent family tree for Fulvestrant.
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NCE-1 Patent Expiry in the Next 1 Year
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Recently Granted Patents in EP
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Clinical Trials
Recent Clinical Trials on Fulvestrant:
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.
Fulvestrant's
generic launch date based on the expiry of its last outstanding patent is estimated to be May 17, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fulvestrant Generic
API
suppliers:
Fulvestrant is the generic name
for
the brand Fulvestrant.
14 different companies have already filed for the generic of Fulvestrant, with Eugia Pharma having the maximum number of approved applications.
Check out the entire list of companies
who have already received approval for Fulvestrant's
generic
Alternative Brands for
Fulvestrant
Fulvestrant
which is used for treating hormone receptor-positive advanced breast cancer in postmenopausal women., has several other brand drugs using the same active ingredient (Fulvestrant).
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.
Fulvestrant is a drug owned by Fresenius Kabi Usa Llc. It is used for treating hormone receptor-positive advanced breast cancer in postmenopausal women. Fulvestrant uses Fulvestrant as an active ingredient. Fulvestrant was launched by Fresenius Kabi in 2019.
Approval Date:
Fulvestrant was approved by
FDA for market
use on 20 May, 2019.
