Wegovy Flextouch is a drug owned by Novo Nordisk Inc. It is protected by 5 US drug patents filed in 2026 out of which none have expired yet. Wegovy Flextouch'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 May 13, 2040. Details of Wegovy Flextouch's patents and their expiration are given in the table below.
| 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. | |||
| US8129343 | Acylated GLP-1 compounds |
Dec, 2031
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11478533 | Semaglutide For Use In Medicine |
May, 2040
(13 years from now) | Active |
| US12029779 | Semaglutide in medical therapy |
Oct, 2038
(12 years from now) | Active |
| US12551536 | Semaglutide In Medical Therapy |
Oct, 2038
(12 years from now) | Active |
| US9764003 | Use of long-acting GLP-1 peptides |
Jun, 2033
(6 years from now) | Active |
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 Flextouch and ongoing
litigations to
help you estimate the early arrival of Wegovy Flextouch generic.
Wegovy Flextouch's Litigations
Wegovy Flextouch 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 Flextouch's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8129343 | March, 2023 |
Institution Denied
(02 Oct, 2023) | Novo Nordisk A/S | Mylan Pharmaceuticals Inc. et al. |
FDA has granted some exclusivities to Wegovy Flextouch. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Wegovy Flextouch,
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 Flextouch.
Exclusivity Information
Wegovy Flextouch holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Wegovy Flextouch's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-935) | Mar 08, 2027 |
| New Indication(I-973) | Aug 15, 2028 |
Several oppositions have been filed on Wegovy Flextouch'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 Flextouch's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Wegovy Flextouch patents.
Wegovy Flextouch's Oppositions Filed in EPO
Wegovy Flextouch 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 Flextouch 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 Flextouch's family patents as well as insights into
ongoing legal events
on those patents.
Wegovy Flextouch's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Wegovy Flextouch:
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 Flextouch(Semaglutide) has 5 clinical trials that have been verified in 2024. Out of these 5, 1 trial is in PHASE4.
Generic Launch
Generic Release Date:
Wegovy Flextouch's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 13, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Wegovy Flextouch Generics:
There are no approved generic versions for Wegovy Flextouch as of now.
How can I launch a generic of Wegovy Flextouch before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Wegovy Flextouch's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Wegovy Flextouch'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 Flextouch -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 20 Oct, 2022 | 17 Feb, 2041 | Less |
Alternative Brands for Wegovy Flextouch
There are several other brand drugs in the same treatment category and using the same active ingredient (Semaglutide) as Wegovy Flextouch. 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.
About Wegovy Flextouch
Wegovy Flextouch is a drug owned by Novo Nordisk Inc. Wegovy Flextouch uses Semaglutide as an active ingredient. Wegovy Flextouch was launched by Novo Nordisk in 2021.
Approval Date:
Wegovy Flextouch 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 Flextouch is 04 June, 2021, its NCE-1 date is estimated to be 05 December, 2021.
Active Ingredient:
Wegovy Flextouch uses Semaglutide as the active ingredient. Check out other Drugs and Companies using Semaglutide ingredient
Dosage:
Wegovy Flextouch is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 9.6MG/3ML (3.2MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |