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Last Updated: December 15, 2019

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OZEMPIC Drug Profile

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Which patents cover Ozempic, and when can generic versions of Ozempic launch?

Ozempic is a drug marketed by Novo and is included in one NDA. There are twenty-two patents protecting this drug.

This drug has two hundred and twenty-two patent family members in twenty-five countries.

The generic ingredient in OZEMPIC 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 Ozempic

Ozempic 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.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.

Drug patent expirations by year for OZEMPIC
Drug Prices for OZEMPIC

See drug prices for OZEMPIC

Recent Clinical Trials for OZEMPIC

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

SponsorPhase
Medical University of South CarolinaPhase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
Case Western Reserve UniversityPhase 2

See all OZEMPIC clinical trials

Recent Litigation for OZEMPIC

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 OZEMPIC litigation

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

US Patents and Regulatory Information for OZEMPIC

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 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 OZEMPIC

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Johnson and Johnson
Merck
Dow
Medtronic

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