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Last Updated: December 8, 2024

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OZEMPIC Drug Patent Profile


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When do Ozempic patents expire, and when can generic versions of Ozempic launch?

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

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

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

DrugPatentWatch® Generic Entry Outlook for Ozempic

Ozempic was eligible for patent challenges on December 5, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 5, 2031. This may change due to patent challenges or generic licensing.

There have been twenty-five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for OZEMPIC
Drug Prices for OZEMPIC

See drug prices for OZEMPIC

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OZEMPIC
Generic Entry Date for OZEMPIC*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OZEMPIC

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

SponsorPhase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Phase 3
University Health Network, TorontoPhase 2
University of Colorado, DenverPhase 3

See all OZEMPIC clinical trials

Pharmacology for OZEMPIC
Paragraph IV (Patent) Challenges for OZEMPIC
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
OZEMPIC Injection semaglutide 2 mg/3 mL 209637 1 2024-04-11
OZEMPIC Injection semaglutide 8 mg/3 mL 209637 1 2022-12-21
OZEMPIC Injection semaglutide 2 mg/1.5 mL and 4 mg/3 mL 209637 7 2021-12-06

US Patents and Regulatory Information for OZEMPIC

OZEMPIC is protected by twenty-four US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OZEMPIC is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OZEMPIC

Syringe device with a dose limiting mechanism and an additional safety mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Use of long-acting GLP-1 peptides
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF TREATING TYPE 2 DIABETES COMPRISING ADMINISTERING SEMAGLUTIDE ONCE WEEKLY IN A AMOUNT OF 1.0 MG TO A SUBJECT IN NEED THEREOF

Injection device with an end of dose feedback mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injection device with a top release mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Syringe device with a dose limiting mechanism and an additional safety mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injection device with a top release mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Needle mounting system and a method for mounting a needle assembly
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Acylated GLP-1 compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: OZEMPIC IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS

Acylated GLP-1 compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS

Acylated GLP-1 compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: OZEMPIC IS INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS

Acylated GLP-1 compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS

Injection device with torsion spring and rotatable display
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injection device with a top release mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Dial-down mechanism for wind-up pen
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Injection device with an end of dose feedback mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Injection device with an end of dose feedback mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injection device with a top release mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Injection device with torsion spring and rotatable display
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Injection device with an end of dose feedback mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Dial-down mechanism for wind-up pen
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting OZEMPIC

ADDITION OF A 3RD MAINTENANCE DOSE OF SEMAGLUTIDE
Exclusivity Expiration: ⤷  Sign Up

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 209637-003 Mar 28, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-004 Oct 6, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-004 Oct 6, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for OZEMPIC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-003 Mar 28, 2022 ⤷  Sign Up ⤷  Sign Up
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-004 Oct 6, 2022 ⤷  Sign Up ⤷  Sign Up
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-003 Mar 28, 2022 ⤷  Sign Up ⤷  Sign Up
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 ⤷  Sign Up ⤷  Sign Up
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for OZEMPIC

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Novo Nordisk A/S Wegovy semaglutide EMEA/H/C/005422
Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of- ≥30 kg/m² (obesity), or- ≥27 kg/m² to
Authorised no no no 2022-01-06
Novo Nordisk A/S Ozempic semaglutide EMEA/H/C/004174
Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;in addition to other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Authorised no no no 2018-02-08
Novo Nordisk A/S Rybelsus semaglutide EMEA/H/C/004953
Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin combination with other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Authorised no no no 2020-04-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for OZEMPIC

When does loss-of-exclusivity occur for OZEMPIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06224536
Patent: Acylated GLP-1 compounds
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 76446
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0607762
Patent: anÁlogo de glp-1, mÉtodo para aumentar o tempo de aÇço em um paciente de um anÁlogo de glp-1, composiÇço farmacÊutica, e, uso de um composto
Estimated Expiration: ⤷  Sign Up

Patent: 2019002626
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 01784
Patent: COMPOSES DE GLP-1 ACYLES (ACYLATED GLP-1 COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1133082
Patent: Acylated GLP-1 compounds
Estimated Expiration: ⤷  Sign Up

Patent: 4017062
Patent: Acylated GLP-1 compounds
Estimated Expiration: ⤷  Sign Up

Patent: 4402989
Patent: ACYLATED GLP-1 COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 63839
Estimated Expiration: ⤷  Sign Up

Patent: 22546
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 63839
Patent: COMPOSES DE GLP-1 ACYLES (ACYLATED GLP-1 COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 22546
Patent: Composés GLP-1 acylés (Acylated GLP-1 compounds)
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2006015928
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 28194
Estimated Expiration: ⤷  Sign Up

Patent: 800019
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 4051
Patent: תרכובות glp-1 שעברו אצילציה, תכשירי רוקחות המכילים אותן ושימוש בהן להכנת תרופות (Acylated glp-1 compounds, pharmaceutical compositions comprising them and their use in the manufacture of medicaments)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 85037
Estimated Expiration: ⤷  Sign Up

Patent: 09463
Estimated Expiration: ⤷  Sign Up

Patent: 08533105
Estimated Expiration: ⤷  Sign Up

Patent: 10116407
Patent: ACYLATED GLP-1 COMPOUND
Estimated Expiration: ⤷  Sign Up

Patent: 13063984
Patent: ACYLATED GLP-1 COMPOUND
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 07011220
Patent: COMPUESTOS DE PEPTIDO 1 TIPO GLUCAGON ACILADOS. (ACYLATED GLP-1 COMPOUNDS.)
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0936
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 7946
Estimated Expiration: ⤷  Sign Up

Patent: 18023
Estimated Expiration: ⤷  Sign Up

Patent: 075342
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 63839
Estimated Expiration: ⤷  Sign Up

Patent: 22546
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 63839
Estimated Expiration: ⤷  Sign Up

Patent: 22546
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 34019
Patent: АЦИЛИРОВАННЫЕ GLP-1 СОЕДИНЕНИЯ (ACYLATED GLP-1 COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 07134156
Patent: АЦИЛИРОВАННЫЕ GLP-1 СОЕДИНЕНИЯ
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0707261
Patent: Acylated GLP-1 compounds
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1205272
Estimated Expiration: ⤷  Sign Up

Patent: 070120089
Patent: ACYLATED GLP-1 COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 50051
Estimated Expiration: ⤷  Sign Up

Patent: 57313
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 62392
Estimated Expiration: ⤷  Sign Up

Patent: 72629
Estimated Expiration: ⤷  Sign Up

Patent: 0700433
Patent: Acylated glp-1 compounds
Estimated Expiration: ⤷  Sign Up

Patent: 0942255
Patent: Acylated GLP-1 compounds
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OZEMPIC around the world.

Country Patent Number Title Estimated Expiration
China 100502968 ⤷  Sign Up
Poland 3300721 ⤷  Sign Up
Russian Federation 2007134156 АЦИЛИРОВАННЫЕ GLP-1 СОЕДИНЕНИЯ ⤷  Sign Up
Germany 602005017182 ⤷  Sign Up
Russian Federation 2005102605 СИСТЕМА ДЛЯ УСТАНОВКИ ИГЛЫ И СПОСОБ КРЕПЛЕНИЯ УЗЛА С ИГЛОЙ ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OZEMPIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 C201830026 Spain ⤷  Sign Up 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 132018000000262 Italy ⤷  Sign Up PRODUCT NAME: SEMAGLUTIDE(OZEMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1251, 20180212
1863839 22/2018 Austria ⤷  Sign Up PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839 2018C/016 Belgium ⤷  Sign Up PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839 122018000075 Germany ⤷  Sign Up PRODUCT NAME: OZEMPIC-SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.