Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Merck
McKesson
Moodys
Mallinckrodt

Last Updated: June 27, 2022

OZEMPIC Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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-three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in OZEMPIC is semaglutide. Three 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 fourteen 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

< Available with Subscription >

  Try it Free

Drug patent expirations by year for OZEMPIC
Drug Prices for OZEMPIC

See drug prices for OZEMPIC

DrugPatentWatch® Estimated Generic Entry Opportunity 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
State University of New York at BuffaloPhase 4
University of Erlangen-Nürnberg Medical SchoolPhase 4
Rehman Medical Institute - RMIEarly Phase 1

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/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-six US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OZEMPIC is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of long-acting GLP-1 peptides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with a top release mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Syringe device with a dose limiting mechanism and an additional safety mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with reset feature
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Needle mounting system and a method for mounting a needle assembly
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Acylated GLP-1 compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS

Needle mounting system and a method for mounting a needle assembly
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with reset feature
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection device with torsion spring and rotatable display
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with a top release mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dial-down mechanism for wind-up pen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection device with an end of dose feedback mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection device with an end of dose feedback mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with reset feature
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with a top release mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection device with torsion spring and rotatable display
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection device with an end of dose feedback mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dial-down mechanism for wind-up pen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting OZEMPIC

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NON-FATAL MYOCARDIAL INFARCTION OR NON-FATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
Exclusivity Expiration: See Plans and Pricing

ADDITION OF A 3RD MAINTENANCE DOSE OF SEMAGLUTIDE
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-001 Dec 5, 2017 See Plans and Pricing See Plans and Pricing
Novo OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637-002 Apr 9, 2019 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Austria

Patent: 6446
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0607762
Estimated Expiration: See Plans and Pricing

Canada

Patent: 01784
Estimated Expiration: See Plans and Pricing

China

Patent: 1133082
Estimated Expiration: See Plans and Pricing

Patent: 4017062
Estimated Expiration: See Plans and Pricing

Patent: 4402989
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 63839
Estimated Expiration: See Plans and Pricing

Patent: 22546
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 63839
Estimated Expiration: See Plans and Pricing

Patent: 22546
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2006015928
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 28194
Estimated Expiration: See Plans and Pricing

Patent: 800019
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4051
Estimated Expiration: See Plans and Pricing

Japan

Patent: 85037
Estimated Expiration: See Plans and Pricing

Patent: 09463
Estimated Expiration: See Plans and Pricing

Patent: 08533105
Estimated Expiration: See Plans and Pricing

Patent: 10116407
Estimated Expiration: See Plans and Pricing

Patent: 13063984
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07011220
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0936
Estimated Expiration: See Plans and Pricing

Norway

Patent: 7946
Estimated Expiration: See Plans and Pricing

Patent: 18023
Estimated Expiration: See Plans and Pricing

Patent: 075342
Estimated Expiration: See Plans and Pricing

Poland

Patent: 63839
Estimated Expiration: See Plans and Pricing

Patent: 22546
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 63839
Estimated Expiration: See Plans and Pricing

Patent: 22546
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 34019
Estimated Expiration: See Plans and Pricing

Patent: 07134156
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0707261
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1205272
Estimated Expiration: See Plans and Pricing

Patent: 070120089
Estimated Expiration: See Plans and Pricing

Spain

Patent: 50051
Estimated Expiration: See Plans and Pricing

Patent: 57313
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 62392
Estimated Expiration: See Plans and Pricing

Patent: 72629
Estimated Expiration: See Plans and Pricing

Patent: 0700433
Estimated Expiration: See Plans and Pricing

Patent: 0942255
Estimated Expiration: See Plans and Pricing

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
Australia 2006278928 Syringe device with a dose limiting mechanism and an additional safety mechanism See Plans and Pricing
Germany 602006015928 See Plans and Pricing
Russian Federation 2005102605 СИСТЕМА ДЛЯ УСТАНОВКИ ИГЛЫ И СПОСОБ КРЕПЛЕНИЯ УЗЛА С ИГЛОЙ See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OZEMPIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 2018C/016 Belgium See Plans and Pricing PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839 661 Finland See Plans and Pricing
1863839 2018/017 Ireland See Plans and Pricing PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
>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:

Mallinckrodt
Boehringer Ingelheim
Moodys
McKinsey
Johnson and Johnson
Baxter

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.