Rybelsus is a drug owned by Novo Nordisk Inc. It is protected by 11 US drug patents filed from 2019 to 2023 out of which none have expired yet. Rybelsus'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 02, 2034. Details of Rybelsus'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
(7 years from now) | Active |
| US8536122 | Acylated GLP-1 compounds |
Mar, 2026
(1 year, 3 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). | |||
| US10278923 | Oral dosing of GLP-1 compounds |
May, 2034
(9 years from now) | Active |
| US11759503 | Compositions of GLP-1 peptides and preparation thereof |
Mar, 2033
(8 years from now) | Active |
| US10933120 | Compositions of GLP-1 peptides and preparation thereof |
Mar, 2033
(8 years from now) | Active |
| US11759501 | Compositions of GLP-1 peptides and preparation thereof |
Mar, 2033
(8 years from now) | Active |
| US11759502 | Compositions of GLP-1 peptides and preparation thereof |
Mar, 2033
(8 years from now) | Active |
| US10086047 | Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid |
Dec, 2031
(7 years from now) | Active |
| US9278123 | Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid |
Dec, 2031
(7 years from now) | Active |
| US10960052 | Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl) amino) caprylic acid |
Dec, 2031
(7 years from now) | Active |
| US11382957 | Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid |
Dec, 2031
(7 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 Rybelsus's patents.
Latest Legal Activities on Rybelsus's Patents
Given below is the list of recent legal activities going on the following patents of Rybelsus.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 20 Sep, 2023 | US11759501 |
| Email Notification Critical | 20 Sep, 2023 | US11759502 |
| Email Notification Critical | 20 Sep, 2023 | US11759503 |
| Patent Issue Date Used in PTA Calculation Critical | 19 Sep, 2023 | US11759501 |
| Mail Patent eGrant Notification | 19 Sep, 2023 | US11759502 |
| Recordation of Patent Grant Mailed Critical | 19 Sep, 2023 | US11759501 |
| Patent eGrant Notification | 19 Sep, 2023 | US11759501 |
| Recordation of Patent eGrant | 19 Sep, 2023 | US11759501 |
| Mail Patent eGrant Notification | 19 Sep, 2023 | US11759501 |
| Sequence Moved to Public Database | 19 Sep, 2023 | US11759501 |
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 Rybelsus and ongoing litigations to help you estimate the early arrival of Rybelsus generic.
Rybelsus's Litigations
Rybelsus 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 Rybelsus'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 Rybelsus. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rybelsus, 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 Rybelsus.
Exclusivity Information
Rybelsus holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Rybelsus's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 20, 2022 |
| New Chemical Entity Exclusivity(NCE) | Dec 05, 2022 |
| M(M-252) | Jan 16, 2023 |
Several oppositions have been filed on Rybelsus'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 Rybelsus's generic, the next section provides detailed information on ongoing and past EP oppositions related to Rybelsus patents.
Rybelsus's Oppositions Filed in EPO
Rybelsus 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 |
|---|---|---|---|
| | |||
| EP17204363A | Dec, 2020 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP17204363A | Dec, 2020 | Galenicum Health S.L.U. | Granted and Under Opposition |
| EP17204363A | Dec, 2020 | Hexal AG | Granted and Under Opposition |
| EP17204363A | Dec, 2020 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP14721834A | May, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP13709231A | May, 2019 | Hexal AG | Granted and Under Opposition |
| EP14721834A | May, 2019 | Hexal AG | Granted and Under Opposition |
| EP14721834A | May, 2019 | Galenicum Health S.L.U. | Granted and Under Opposition |
| EP14721834A | May, 2019 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
| EP13709231A | May, 2019 | Galenicum Health S.L.U. | Granted and Under Opposition |
| EP13709231A | May, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP14721834A | May, 2019 | Sanofi | Granted and Under Opposition |
| EP14721834A | May, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP13709231A | May, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP11805824A | Sep, 2018 | Hexal AG | Granted and Under Opposition |
| EP11805824A | Sep, 2018 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP11805824A | Sep, 2018 | Galenicum Health S.L. | Granted and Under Opposition |
| EP11805824A | Sep, 2018 | Teva Pharmaceutical Industries Ltd | 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 Rybelsus 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 Rybelsus's family patents as well as insights into ongoing legal events on those patents.
Rybelsus's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Rybelsus:
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. Rybelsus(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:
Rybelsus's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 02, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rybelsus Generics:
There are no approved generic versions for Rybelsus as of now.
Alternative Brands for Rybelsus
Rybelsus which is used for managing type 2 diabetes mellitus., 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 Rybelsus
Rybelsus is a drug owned by Novo Nordisk Inc. It is used for managing type 2 diabetes mellitus. Rybelsus uses Semaglutide as an active ingredient. Rybelsus was launched by Novo in 2019.
Approval Date:
Rybelsus was approved by FDA for market use on 20 September, 2019.
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 Rybelsus is 20 September, 2019, its NCE-1 date is estimated to be 05 December, 2021.
Active Ingredient:
Rybelsus uses Semaglutide as the active ingredient. Check out other Drugs and Companies using Semaglutide ingredient
Treatment:
Rybelsus is used for managing type 2 diabetes mellitus.
Dosage:
Rybelsus is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG | TABLET | Prescription | ORAL |
| 7MG | TABLET | Prescription | ORAL |
| 14MG | TABLET | Prescription | ORAL |