Wegovy is a drug owned by Novo Nordisk Inc. It is protected by 7 US drug patents filed from 2021 to 2024 out of which none have expired yet. Wegovy'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'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
(6 years from now) | Active |
| US8536122 | Acylated GLP-1 compounds |
Mar, 2026
(1 year, 2 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11318191 | GLP-1 compositions and uses thereof |
Feb, 2041
(16 years from now) | Active |
| US12029779 | Semaglutide in medical therapy |
Oct, 2038
(13 years from now) | Active |
| US10888605 | GLP-1 compositions and uses thereof |
Aug, 2038
(13 years from now) | Active |
| US11752198 | GLP-1 compositions and uses thereof |
Aug, 2038
(13 years from now) | Active |
| US9764003 | Use of long-acting GLP-1 peptides |
Jun, 2033
(8 years from now) | Active |
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 Wegovy's patents.
Latest Legal Activities on Wegovy's Patents
Given below is the list of recent legal activities going on the following patents of Wegovy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jun, 2024 | US10888605 (Litigated) |
| Email Notification Critical | 12 Sep, 2023 | US11752198 |
| Recordation of Patent eGrant | 12 Sep, 2023 | US11752198 |
| Patent eGrant Notification | 12 Sep, 2023 | US11752198 |
| Recordation of Patent Grant Mailed Critical | 12 Sep, 2023 | US11752198 |
| Mail Patent eGrant Notification | 12 Sep, 2023 | US11752198 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Sep, 2023 | US11752198 |
| Email Notification Critical | 24 Aug, 2023 | US11752198 |
| Issue Notification Mailed Critical | 23 Aug, 2023 | US11752198 |
| Dispatch to FDC | 24 Jul, 2023 | US11752198 |
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 and ongoing litigations to help you estimate the early arrival of Wegovy generic.
Wegovy's Litigations
Wegovy been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 16, 2023, against patent number US8536122. 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'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. |
| US8536122 | March, 2023 |
Institution Denied
(02 Oct, 2023) | Novo Nordisk A/S | Mylan Pharmaceuticals Inc. et al. |
FDA has granted some exclusivities to Wegovy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Wegovy, 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.
Exclusivity Information
Wegovy holds 5 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Wegovy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 05, 2022 |
| New Product(NP) | Jun 04, 2024 |
| New Patient Population(NPP) | Dec 23, 2025 |
| New Dosing Schedule(D-190) | Jul 21, 2026 |
| New Indication(I-935) | Mar 08, 2027 |
Several oppositions have been filed on Wegovy'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's generic, the next section provides detailed information on ongoing and past EP oppositions related to Wegovy patents.
Wegovy's Oppositions Filed in EPO
Wegovy 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 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's family patents as well as insights into ongoing legal events on those patents.
Wegovy's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Wegovy:
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(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'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 Generics:
There are no approved generic versions for Wegovy as of now.
How can I launch a generic of Wegovy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Wegovy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Wegovy'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.25 mg/0.5 mL 0.5 mg/0.5 mL 1 mg/0.5 mL 1.7 mg/0.75 mL 2.4 mg/0.75 mL | 20 Oct, 2022 | 1 | 17 Feb, 2041 |
Alternative Brands for Wegovy
Wegovy which is used for weight management., has several other brand drugs using the same active ingredient (Semaglutide). 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.
About Wegovy
Wegovy is a drug owned by Novo Nordisk Inc. It is used for weight management. Wegovy uses Semaglutide as an active ingredient. Wegovy was launched by Novo in 2021.
Approval Date:
Wegovy 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 is 04 June, 2021, its NCE-1 date is estimated to be 05 December, 2021.
Active Ingredient:
Wegovy uses Semaglutide as the active ingredient. Check out other Drugs and Companies using Semaglutide ingredient
Treatment:
Wegovy is used for weight management.
Dosage:
Wegovy is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5MG/0.5ML (0.5MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 2.4MG/0.75ML (2.4MG/0.75ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 0.25MG/0.5ML (0.25MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 1.7MG/0.75ML (1.7MG/0.75ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 1MG/0.5ML (1MG/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |