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Last Updated: December 14, 2019

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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 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 seventy-one patent family members in twenty-eight countries.

Two suppliers are listed for this compound.

Recent Clinical Trials for semaglutide

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

SponsorPhase
Dasman Diabetes InstitutePhase 4
Steno Diabetes Center CopenhagenPhase 4
Sabyasachi SenPhase 3

See all semaglutide clinical trials

Recent Litigation for semaglutide

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-03
SMITH v. NOVO NORDISK INC.2016-08-08

See all semaglutide litigation

Pharmacology for semaglutide
Synonyms for semaglutide
53AXN4NNHX
910463-68-2
910463-93-3
EX-A2424
GTPL9724
NN 9535
NN-9535
NN9535
NNC 0113-0217
Ozempic
Semaglutide [USAN:INN]
Sermaglutide
UNII-53AXN4NNHX

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 209637-001 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 Y   Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes   Start Trial   Start Trial Y   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
Novo RYBELSUS semaglutide TABLET;ORAL 213051-002 Sep 20, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 RX Yes Yes   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 semaglutide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 CR 2018 00019 Denmark   Start Trial PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212
1863839 122018000075 Germany   Start Trial PRODUCT NAME: OZEMPIC-SEMAGLUTID; 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 1890018-3 Sweden   Start Trial PRODUCT NAME: SEMAGLUTIDE; REG. 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 22/2018 Austria   Start Trial PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
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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