Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
Express Scripts
Dow
McKesson
McKinsey

Last Updated: September 27, 2022

RYBELSUS Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 eight patents protecting this drug.

This drug has one hundred and forty-three 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 four 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

< Available with Subscription >

  Try it Free

Drug patent expirations by year for RYBELSUS
Drug Prices for RYBELSUS

See drug prices for RYBELSUS

DrugPatentWatch® Estimated Generic Entry Opportunity 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
Medical University of BialystokN/A
University of Erlangen-Nürnberg Medical SchoolPhase 4
University of PalermoN/A

See all RYBELSUS clinical trials

Pharmacology for RYBELSUS

US Patents and Regulatory Information for RYBELSUS

RYBELSUS is protected by eight US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RYBELSUS is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Oral dosing of GLP-1 compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS

Compositions of GLP-1 peptides and preparation thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl) amino) caprylic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Acylated GLP-1 compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS

Acylated GLP-1 compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS

FDA Regulatory Exclusivity protecting RYBELSUS

ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
Exclusivity Expiration: See Plans and Pricing

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novo RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novo RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo RYBELSUS semaglutide TABLET;ORAL 213051-001 Sep 20, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novo RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 exercise, , , as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, in 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: See Plans and Pricing

Patent: 17251814
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014023374
Estimated Expiration: See Plans and Pricing

Canada

Patent: 68188
Estimated Expiration: See Plans and Pricing

China

Patent: 4203266
Estimated Expiration: See Plans and Pricing

Patent: 7812181
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0181447
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20767
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 27885
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 27885
Estimated Expiration: See Plans and Pricing

Patent: 88857
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 39406
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4228
Estimated Expiration: See Plans and Pricing

Japan

Patent: 01158
Estimated Expiration: See Plans and Pricing

Patent: 15512374
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 27885
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 1146
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 3067
Estimated Expiration: See Plans and Pricing

Patent: 14010685
Estimated Expiration: See Plans and Pricing

Poland

Patent: 27885
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 27885
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 41198
Estimated Expiration: See Plans and Pricing

Patent: 14141700
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 727
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 27885
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1406250
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2072202
Estimated Expiration: See Plans and Pricing

Patent: 2266299
Estimated Expiration: See Plans and Pricing

Patent: 140138873
Estimated Expiration: See Plans and Pricing

Patent: 200013078
Estimated Expiration: See Plans and Pricing

Spain

Patent: 90553
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 3976
Estimated Expiration: See Plans and Pricing

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
Mexico 2015015009 DOSIFICACION ORAL DE COMPUESTOS PEPTIDO SIMILAR AL GLAUCON-1 (GLP-1). (ORAL DOSING OF GLP-1 COMPOUNDS.) See Plans and Pricing
Brazil 112014023374 composições de peptídeos de glp-1 e preparação das mesmas See Plans and Pricing
Hungary E048850 See Plans and Pricing
Japan 5902194 See Plans and Pricing
Lithuania 2827885 See Plans and Pricing
Russian Federation 2671406 ПЕРОРАЛЬНАЯ ДОЗИРОВАННАЯ ФОРМА СОЕДИНЕНИЙ ГЛЮКАГОНОПОДОБНОГО ПЕПТИДА-1 (ORAL DOSING OF GLUCAGON-LIKE PEPTIDE-1 COMPOUNDS) See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839 SPC/GB18/023 United Kingdom See Plans and Pricing 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 22/2018 Austria See Plans and Pricing PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839 300936 Netherlands See Plans and Pricing PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839 2018/017 Ireland See Plans and Pricing PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839 18C1017 France See Plans and Pricing PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Medtronic
Johnson and Johnson
McKinsey
AstraZeneca

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.