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 eleven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and fifty-one patent family members in thirty 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 seven 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
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Questions you can ask:
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Summary for RYBELSUS
| International Patents: | 151 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 16 |
| Clinical Trials: | 9 |
| Patent Applications: | 702 |
| 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
*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 |
|---|---|
| Alzheimer's Association | Phase 2 |
| Rutgers, The State University of New Jersey | Phase 2 |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 |
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 | 3 mg, 7 mg and 14 mg | 213051 | 1 | 2024-07-15 |
US Patents and Regulatory Information for RYBELSUS
RYBELSUS is protected by eleven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of RYBELSUS is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting RYBELSUS
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Oral dosing of GLP-1 compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Compositions of GLP-1 peptides and preparation thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl) amino) caprylic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Acylated GLP-1 compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Acylated GLP-1 compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
| 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 | 213051-003 | Sep 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-003 | Sep 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novo | RYBELSUS | semaglutide | TABLET;ORAL | 213051-003 | Sep 20, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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/005422 Wegovy 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/004174 Treatment 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/004953 Rybelsus 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
Patent: Compositions of GLP-1 peptides and preparation thereof
Estimated Expiration: ⤷ Sign Up
Patent: 17251814
Patent: Compositions of GLP-1 peptides and preparation thereof
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2014023374
Patent: composições de peptídeos de glp-1 e preparação das mesmas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 68188
Patent: COMPOSITIONS DE PEPTIDES GLP-1 ET LEUR PREPARATION (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF)
Estimated Expiration: ⤷ Sign Up
China
Patent: 4203266
Patent: Compositions of GLP-1 peptides and preparation thereof
Estimated Expiration: ⤷ Sign Up
Patent: 7812181
Patent: GLP‑1肽组合物及其制备 (Compositions of GLP-1 peptides and preparation thereof)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0181447
Estimated Expiration: ⤷ Sign Up
Patent: 0231060
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20767
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 27885
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 27885
Patent: COMPOSITIONS DE PEPTIDES GLP-1 ET LEUR PRÉPARATION (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 88857
Patent: COMPOSITIONS DE PEPTIDES GLP-1 ET LEUR PRÉPARATION (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 24475
Patent: COMPOSITIONS DE PEPTIDES GLP-1 ET LEUR PRÉPARATION (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 39406
Estimated Expiration: ⤷ Sign Up
Patent: 62740
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4228
Patent: תכשירים של פפטידים 1 - glp והכנתם (Compositions of glp-1 peptides and preparation thereof)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 01158
Estimated Expiration: ⤷ Sign Up
Patent: 15512374
Patent: ＧＬＰ−１ペプチドの組成物、及びその調製
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 27885
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 1146
Patent: COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 3067
Patent: COMPOSICIONES DE PEPTIDOS DE GLP-1 Y PREPARACIONES DE LAS MISMAS. (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF.)
Estimated Expiration: ⤷ Sign Up
Patent: 14010685
Patent: COMPOSICIONES DE PEPTIDOS DE GLP-1 Y PREPARACIONES DE LAS MISMAS. (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF.)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 27885
Estimated Expiration: ⤷ Sign Up
Patent: 88857
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 27885
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 41198
Patent: КОМПОЗИЦИИ GLP-1 ПЕПТИДОВ И ИХ ПОЛУЧЕНИЕ (GLP-1 PEPTIDES COMPOSITIONS AND THEIR PRODUCTION)
Estimated Expiration: ⤷ Sign Up
Patent: 14141700
Patent: КОМПОЗИЦИИ GLP-1 ПЕПТИДОВ И ИХ ПОЛУЧЕНИЕ
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 727
Patent: KOMPOZICIJE GLP-1 PEPTIDA I NJIHOVO DOBIJANJE (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 460
Patent: KOMPOZICIJE GLP-1 PEPTIDA I NJIHOVA PRIPREMA (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 27885
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1406250
Patent: COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2072202
Estimated Expiration: ⤷ Sign Up
Patent: 2266299
Estimated Expiration: ⤷ Sign Up
Patent: 140138873
Patent: COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 200013078
Patent: ＧＬＰ-1 펩티드의 조성물 및 그것의 제조 (-1 COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 90553
Estimated Expiration: ⤷ Sign Up
Patent: 52874
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 3976
Patent: КОМПОЗИЦІЯ СОЛІ N-(8-(2-ГІДРОКСИБЕНЗОЇЛ)АМІНО)КАПРИЛОВОЇ КИСЛОТИ І ПЕПТИДУ GLP-1
Estimated Expiration: ⤷ Sign Up
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 | 4324475 | COMPOSITIONS DE PEPTIDES GLP-1 ET LEUR PRÉPARATION (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF) | ⤷ Sign Up |
| Russian Federation | 2014141700 | КОМПОЗИЦИИ GLP-1 ПЕПТИДОВ И ИХ ПОЛУЧЕНИЕ | ⤷ Sign Up |
| Spain | 2793423 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RYBELSUS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1863839 | 2018C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212 |
| 1863839 | 22/2018 | Austria | ⤷ Sign Up | PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212 |
| 1863839 | CR 2018 00019 | Denmark | ⤷ Sign Up | PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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