Wegovy Hd is a drug owned by Novo Nordisk Inc. It is protected by 9 US drug patents filed in 2026 out of which none have expired yet. Wegovy Hd's patents have been open to challenges since 05 December, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 17, 2041. Details of Wegovy Hd'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 protect the active ingredient(API) of the drug.
Only drug patent owner can launch products that use this
active ingredient until these patents expire.
While patent expiration is one way of estimating the generic date of a drug, if a patent gets
invalidated somehow, the
generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal
pitfalls. Given
below are details of the litigation history of Wegovy Hd and ongoing
litigations to
help you estimate the early arrival of Wegovy Hd generic.
Wegovy Hd's
Litigations
Wegovy Hd been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 16, 2023, against patent number US8129343. The petitioner Mylan Pharmaceuticals Inc. et al., challenged the validity of this patent, with Novo Nordisk A/S as the respondent. Click below to track the latest information on how companies are challenging
Wegovy Hd's patents.
FDA has granted some exclusivities to Wegovy Hd. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Wegovy Hd,
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
Wegovy Hd.
Exclusivity Information
Wegovy Hd holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029.
Details of Wegovy Hd's exclusivity codes and their expiration dates are given
below.
Drug Exclusivity
Drug Exclusivity Expiration
New Strength(NS)
Mar 19, 2029
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Several oppositions have been filed on Wegovy Hd'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 Wegovy Hd's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Wegovy Hd patents.
Wegovy Hd's
Oppositions Filed in EPO
Wegovy Hd has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 04, 2011, by Amylin Pharmaceuticals, Inc.. This opposition was filed on patent number EP06725149A. Click below to
reveal the latest
opposition data.
Application
Filing Date
Opposition Party
Legal Status
EP13737808A
Jan, 2021
Galenicum Health S.L.U.
Granted and Under Opposition
EP13737808A
Jan, 2021
Teva Pharmaceutical Industries LTD.
Granted and Under Opposition
EP13737808A
Jan, 2021
Generics [UK] Limited
Granted and Under Opposition
EP06725149A
May, 2011
AMYLIN PHARMACEUTICALS, INC.
Opposition rejected
US patents provide insights into the exclusivity only within the United States, but
Wegovy Hd 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 Wegovy Hd's family patents as well as insights into
ongoing legal events
on those patents.
Wegovy Hd's Family Patents
Wegovy Hd has
patent protection in a total of 32 countries. It's US patent count contributes only to 10.9% of its total global patent coverage. Click below to unlock the full patent family tree for Wegovy Hd.
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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 Wegovy Hd:
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. Wegovy Hd(Semaglutide) has 5 clinical trials that have been verified in 2024. Out of these 5, 1 trial is in PHASE4.
Wegovy Hd's
generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 17, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Wegovy Hd Generics:
There are no approved generic versions for Wegovy Hd as of now.
How can I launch a generic of Wegovy Hd before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before
the expiration of Wegovy Hd's patents related
by providing a 'paragraph IV certification' in your
application, which states that the patent submitted by the
Wegovy Hd'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 Wegovy Hd -
There are several other brand drugs in the
same treatment categoryand using the same active ingredient (Semaglutide) as Wegovy Hd.
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.
Apart from
drugs working in same treatment category, there are also some brand drugs where treatment area is
different, but
the active ingredient used is same i.e. Semaglutide. Given below
is the list
of those drugs and companies owning them.
Wegovy Hd is a drug owned by Novo Nordisk Inc. Wegovy Hd uses Semaglutide as an active ingredient. Wegovy Hd was launched by Novo Nordisk in 2021.
Approval Date:
Wegovy Hd was approved by
FDA for market
use on 04 June, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four
years after the
original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA
with a Paragraph
IV certification. This is the earliest point when generic competition might begin, provided the
challenge is
successful. Since the approval date for Wegovy Hd is
04 June, 2021, its
NCE-1 date is estimated to be 05 December, 2021.
