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Last Updated: September 23, 2021

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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 seven patents protecting this drug.

This drug has one hundred and thirty-seven patent family members in twenty-eight countries.

The generic ingredient in RYBELSUS is semaglutide. Three suppliers are listed for this compound. Additional details are available on the semaglutide profile page.

DrugPatentWatch® Generic Entry Outlook for Rybelsus

Rybelsus will be eligible for patent challenges on December 5, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for RYBELSUS
Drug patent expirations by year for RYBELSUS
Drug Prices for RYBELSUS

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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

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SponsorPhase
Novo Nordisk A/SPhase 3

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Pharmacology for RYBELSUS

US Patents and Regulatory Information for RYBELSUS

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novo RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novo RYBELSUS semaglutide TABLET;ORAL 213051-001 Sep 20, 2019 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Novo RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for RYBELSUS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 2018C/016 Belgium ⤷  Try it Free PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839 2018/017 Ireland ⤷  Try it Free PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839 22/2018 Austria ⤷  Try it Free PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839 C201830026 Spain ⤷  Try it Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.