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Last Updated: November 24, 2020

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Semaglutide - Generic Drug Details

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What are the generic sources for semaglutide and what is the scope of patent protection?

Semaglutide is the generic ingredient in two branded drugs marketed by Novo and is included in two NDAs. There are twenty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Semaglutide has two hundred and ninety-seven patent family members in twenty-nine countries.

Three suppliers are listed for this compound.

Recent Clinical Trials for semaglutide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Cleveland ClinicPhase 4
AstraZenecaPhase 2
The University of Texas Health Science Center, HoustonPhase 2

See all semaglutide clinical trials

Pharmacology for semaglutide

US Patents and Regulatory Information for semaglutide

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   Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 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
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes   Start Trial   Start Trial 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 semaglutide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 300936 Netherlands   Start Trial PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839 C01863839/01 Switzerland   Start Trial PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018
1863839 1890018-3 Sweden   Start Trial PRODUCT NAME: SEMAGLUTIDE; REG. NO/DATE: EU/1/17/1251 20180212
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 2018/017 Ireland   Start Trial PRODUCT NAME: OZEMPIC-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
Harvard Business School
Merck
Moodys
AstraZeneca
Boehringer Ingelheim

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