RYBELSUS Drug Patent Profile
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When do Rybelsus patents expire, and when can generic versions of Rybelsus launch?
Rybelsus is a drug marketed by Novo and is included in one NDA. There are fifteen patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and ninety-two patent family members in thirty-eight countries.
The generic ingredient in RYBELSUS is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.
DrugPatentWatch® Generic Entry Outlook for Rybelsus
Rybelsus was eligible for patent challenges on December 5, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 15, 2033. This may change due to patent challenges or generic licensing.
There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for RYBELSUS?
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Summary for RYBELSUS
| International Patents: | 192 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 16 |
| Clinical Trials: | 16 |
| Patent Applications: | 1,408 |
| Drug Prices: | Drug price information for RYBELSUS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RYBELSUS |
| What excipients (inactive ingredients) are in RYBELSUS? | RYBELSUS excipients list |
| DailyMed Link: | RYBELSUS at DailyMed |

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RYBELSUS
Generic Entry Date for RYBELSUS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for RYBELSUS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johns Hopkins University | PHASE2 |
| Rune Skovgaard Rasmussen | PHASE2 |
| Herlev Hospital | PHASE2 |
Pharmacology for RYBELSUS
| Drug Class | GLP-1 Receptor Agonist |
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Paragraph IV (Patent) Challenges for RYBELSUS
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| RYBELSUS | Tablets | semaglutide | 1.5 mg, 4 mg and 9 mg | 213051 | 1 | 2025-12-11 |
| RYBELSUS | Tablets | semaglutide | 3 mg, 7 mg and 14 mg | 213051 | 1 | 2024-07-15 |
US Patents and Regulatory Information for RYBELSUS
RYBELSUS is protected by fifteen US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of RYBELSUS is ⤷ Start Trial.
This potential generic entry date is based on patent 10,933,120.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-002 | Sep 20, 2019 | RX | Yes | Yes | 10,960,052 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-005 | Dec 9, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-006 | Dec 9, 2024 | RX | Yes | Yes | 8,536,122 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-003 | Sep 20, 2019 | RX | Yes | Yes | 10,278,923 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-002 | Sep 20, 2019 | RX | Yes | Yes | 11,759,501 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-006 | Dec 9, 2024 | RX | Yes | Yes | 8,129,343 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for RYBELSUS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-004 | Dec 9, 2024 | 8,536,122 | ⤷ Start Trial |
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-001 | Sep 20, 2019 | 8,536,122 | ⤷ Start Trial |
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-005 | Dec 9, 2024 | 8,536,122 | ⤷ Start Trial |
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-006 | Dec 9, 2024 | 8,536,122 | ⤷ Start Trial |
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-002 | Sep 20, 2019 | 8,536,122 | ⤷ Start Trial |
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-003 | Sep 20, 2019 | 8,536,122 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for RYBELSUS
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Novo Nordisk A/S | Wegovy | semaglutide | EMEA/H/C/005422Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of- ≥30 kg/m² (obesity), or- ≥27 kg/m² to | Authorised | no | no | no | 2022-01-06 | |
| Novo Nordisk A/S | Ozempic | semaglutide | EMEA/H/C/004174Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;in addition to other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. | Authorised | no | no | no | 2018-02-08 | |
| Novo Nordisk A/S | Rybelsus | semaglutide | EMEA/H/C/004953Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin combination with other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. | Authorised | no | no | no | 2020-04-03 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for RYBELSUS
When does loss-of-exclusivity occur for RYBELSUS?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 13234496
Estimated Expiration: ⤷ Start Trial
Patent: 17251814
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 2014023374
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 68188
Estimated Expiration: ⤷ Start Trial
China
Patent: 4203266
Estimated Expiration: ⤷ Start Trial
Patent: 7812181
Estimated Expiration: ⤷ Start Trial
Croatia
Patent: 0181447
Estimated Expiration: ⤷ Start Trial
Patent: 0231060
Estimated Expiration: ⤷ Start Trial
Cyprus
Patent: 20767
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 27885
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 27885
Estimated Expiration: ⤷ Start Trial
Patent: 88857
Estimated Expiration: ⤷ Start Trial
Patent: 24475
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 39406
Estimated Expiration: ⤷ Start Trial
Patent: 62740
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 4228
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 01158
Estimated Expiration: ⤷ Start Trial
Patent: 15512374
Estimated Expiration: ⤷ Start Trial
Lithuania
Patent: 27885
Estimated Expiration: ⤷ Start Trial
Malaysia
Patent: 1146
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 3067
Estimated Expiration: ⤷ Start Trial
Patent: 14010685
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 27885
Estimated Expiration: ⤷ Start Trial
Patent: 88857
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 27885
Estimated Expiration: ⤷ Start Trial
Russian Federation
Patent: 41198
Estimated Expiration: ⤷ Start Trial
Patent: 14141700
Estimated Expiration: ⤷ Start Trial
San Marino
Patent: 01800491
Estimated Expiration: ⤷ Start Trial
Serbia
Patent: 727
Estimated Expiration: ⤷ Start Trial
Patent: 460
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 27885
Estimated Expiration: ⤷ Start Trial
South Africa
Patent: 1406250
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 2072202
Estimated Expiration: ⤷ Start Trial
Patent: 2266299
Estimated Expiration: ⤷ Start Trial
Patent: 140138873
Estimated Expiration: ⤷ Start Trial
Patent: 200013078
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 90553
Estimated Expiration: ⤷ Start Trial
Patent: 52874
Estimated Expiration: ⤷ Start Trial
Ukraine
Patent: 3976
Estimated Expiration: ⤷ Start Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering RYBELSUS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 4299118 | ⤷ Start Trial | |
| China | 118662611 | ⤷ Start Trial | |
| Australia | 2014261336 | ⤷ Start Trial | |
| Brazil | 112015026325 | dosagem oral de compostos glp-1 | ⤷ Start Trial |
| Hungary | E036066 | ⤷ Start Trial | |
| South Korea | 101205272 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RYBELSUS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1863839 | C201830026 | Spain | ⤷ Start Trial | PRODUCT NAME: OZEMPIC-SEMAGLUTIDA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1251; DATE OF AUTHORISATION: 20180208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1251; DATE OF FIRST AUTHORISATION IN EEA: 20180208 |
| 1863839 | 300936 | Netherlands | ⤷ Start Trial | PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208 |
| 1863839 | SPC/GB18/023 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: SEMAGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/17/1251 (NI) 20180208; UK PLGB 04668/0331 20180208; UK PLGB 04668/0332 20180208; UK PLGB 04668/0333 20180208 |
| 1863839 | 18C1017 | France | ⤷ Start Trial | PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212 |
| 1863839 | 132018000000262 | Italy | ⤷ Start Trial | PRODUCT NAME: SEMAGLUTIDE(OZEMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1251, 20180212 |
| 1863839 | 122018000075 | Germany | ⤷ Start Trial | PRODUCT NAME: OZEMPIC-SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180208 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
RYBELSUS: Market Dynamics and Financial Trajectory
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