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Last Updated: October 5, 2024

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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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Drug patent expirations by year for RYBELSUS
Drug Prices for RYBELSUS

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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

SponsorPhase
Rutgers, The State University of New JerseyPhase 2
Alzheimer's AssociationPhase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 2

See all RYBELSUS clinical trials

Pharmacology for RYBELSUS
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
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
Japan 2020073533 GLP−1化合物の経口投薬 (ORAL DOSING OF GLP-1 COMPOUNDS) ⤷  Sign Up
Serbia 60321 ČVRSTE KOMPOZICIJE KOJE SADRŽE GLP-1 AGONIST I SO N-(8-(2- HIDROKSIBENZOIL)AMINO)KAPRILNE KISELINE (SOLID COMPOSITIONS COMPRISING A GLP-1 AGONIST AND A SALT OF N-(8-(2- HYDROXYBENZOYL)AMINO)CAPRYLIC ACID) ⤷  Sign Up
Mexico 353067 COMPOSICIONES DE PEPTIDOS DE GLP-1 Y PREPARACIONES DE LAS MISMAS. (COMPOSITIONS OF GLP-1 PEPTIDES AND PREPARATION THEREOF.) ⤷  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 C201830026 Spain ⤷  Sign Up 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 SPC/GB18/023 United Kingdom ⤷  Sign Up 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 2018/017 Ireland ⤷  Sign Up PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839 2018C/016 Belgium ⤷  Sign Up PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND 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.