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Last Updated: November 28, 2021

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SEMAGLUTIDE - Generic Drug Details

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What are the generic drug sources for semaglutide and what is the scope of freedom to operate?

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

Semaglutide has three hundred and fifty-five patent family members in thirty-seven countries.

Three suppliers are listed for this compound.

Recent Clinical Trials for SEMAGLUTIDE

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

SponsorPhase
Warren Peters, MD, MPHPhase 3
Woman'sPhase 4
Filip Krag KnopN/A

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 OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novo RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 122018000075 Germany ⤷  Free Forever Trial PRODUCT NAME: OZEMPIC-SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839 C201830026 Spain ⤷  Free Forever 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 CR 2018 00019 Denmark ⤷  Free Forever Trial PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212
1863839 132018000000262 Italy ⤷  Free Forever Trial PRODUCT NAME: SEMAGLUTIDE(OZEMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1251, 20180212
1863839 18C1017 France ⤷  Free Forever Trial PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
Boehringer Ingelheim
Harvard Business School
McKesson
Baxter

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