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Last Updated: March 19, 2024

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OZEMPIC Drug Patent 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-one patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty-six 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-one 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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  Try a Trial

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
University of Colorado, DenverPhase 3
National Heart, Lung, and Blood Institute (NHLBI)Phase 3
Canadian Medical and Surgical Knowledge Translation Research GroupPhase 4

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 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Use of long-acting GLP-1 peptides
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Automatic injection device with a top release mechanism
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Automatic injection device with a top release mechanism
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Needle mounting system and a method for mounting a needle assembly
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Acylated GLP-1 compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Automatic injection device with a top release mechanism
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dial-down mechanism for wind-up pen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Injection device with an end of dose feedback mechanism
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Injection device with an end of dose feedback mechanism
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Automatic injection device with a top release mechanism
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Injection device with torsion spring and rotatable display
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Injection device with an end of dose feedback mechanism
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dial-down mechanism for wind-up pen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting OZEMPIC

ADDITION OF A 3RD MAINTENANCE DOSE OF SEMAGLUTIDE
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-004 Oct 6, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-004 Oct 6, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 209637-002 Apr 9, 2019 ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-004 Oct 6, 2022 ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 ⤷  Try a Trial ⤷  Try a Trial
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 76446
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0607762
Estimated Expiration: ⤷  Try a Trial

Patent: 2019002626
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 01784
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1133082
Estimated Expiration: ⤷  Try a Trial

Patent: 4017062
Estimated Expiration: ⤷  Try a Trial

Patent: 4402989
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 63839
Estimated Expiration: ⤷  Try a Trial

Patent: 22546
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 63839
Estimated Expiration: ⤷  Try a Trial

Patent: 22546
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2006015928
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 28194
Estimated Expiration: ⤷  Try a Trial

Patent: 800019
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 4051
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 85037
Estimated Expiration: ⤷  Try a Trial

Patent: 09463
Estimated Expiration: ⤷  Try a Trial

Patent: 08533105
Estimated Expiration: ⤷  Try a Trial

Patent: 10116407
Estimated Expiration: ⤷  Try a Trial

Patent: 13063984
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 07011220
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 0936
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 7946
Estimated Expiration: ⤷  Try a Trial

Patent: 18023
Estimated Expiration: ⤷  Try a Trial

Patent: 075342
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 63839
Estimated Expiration: ⤷  Try a Trial

Patent: 22546
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 63839
Estimated Expiration: ⤷  Try a Trial

Patent: 22546
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 34019
Estimated Expiration: ⤷  Try a Trial

Patent: 07134156
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0707261
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1205272
Estimated Expiration: ⤷  Try a Trial

Patent: 070120089
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 50051
Estimated Expiration: ⤷  Try a Trial

Patent: 57313
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 62392
Estimated Expiration: ⤷  Try a Trial

Patent: 72629
Estimated Expiration: ⤷  Try a Trial

Patent: 0700433
Estimated Expiration: ⤷  Try a Trial

Patent: 0942255
Estimated Expiration: ⤷  Try a Trial

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
Austria E499962 ⤷  Try a Trial
Canada 2738877 MECANISME DE RECUL POUR STYLO A ENROULEMENT (DIAL-DOWN MECHANISM FOR WIND-UP PEN) ⤷  Try a Trial
Denmark 1877119 ⤷  Try a Trial
European Patent Office 1687019 FORMULATIONS PEPTIDIQUES A BASE DE PROPYLENE GLYCOL OPTIMALES POUR LA PRODUCTION ET L'UTILISATION DANS DES DISPOSITIFS D'INJECTION (PROPYLENE GLYCOL-CONTAINING PEPTIDE FORMULATIONS WHICH ARE OPTIMAL FOR PRODUCTION AND FOR USE IN INJECTION DEVICES) ⤷  Try a Trial
Brazil 122019002626 ⤷  Try a Trial
Denmark 1863839 ⤷  Try a Trial
Russian Federation 2007114761 МЕХАНИЗМ УСТАНОВКИ ДОЗЫ ДЛЯ ШПРИЦА-РУЧКИ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OZEMPIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 132018000000262 Italy ⤷  Try a Trial PRODUCT NAME: SEMAGLUTIDE(OZEMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1251, 20180212
1863839 18C1017 France ⤷  Try a Trial PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839 C201830026 Spain ⤷  Try a 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 C01863839/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018
1863839 2018C/016 Belgium ⤷  Try a Trial PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839 661 Finland ⤷  Try a Trial
1863839 300936 Netherlands ⤷  Try a 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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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.