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Last Updated: January 19, 2020

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RYBELSUS Drug 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 five patents protecting this drug.

This drug has ninety patent family members in twenty-six countries.

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

US ANDA Litigation and Generic Entry Outlook for Rybelsus

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

Summary for RYBELSUS
International Patents:90
US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Formulation / Manufacturing:see details
DailyMed Link:RYBELSUS at DailyMed
Drug patent expirations by year for RYBELSUS
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 213051-001 Sep 20, 2019 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-001 Sep 20, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-001 Sep 20, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-003 Sep 20, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes No   Start Trial   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

Supplementary Protection Certificates for RYBELSUS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 122018000075 Germany   Start Trial PRODUCT NAME: OZEMPIC-SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839 2018C/016 Belgium   Start Trial PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839 22/2018 Austria   Start Trial PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839 2018/017 Ireland   Start Trial PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
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 18C1017 France   Start Trial PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
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Boehringer Ingelheim
Dow
Medtronic

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