You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

~ Buy the WEGOVY (semaglutide) Drug Profile, 2024 PDF Report in the Report Store ~

WEGOVY Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Wegovy is a drug marketed by Novo and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch® Generic Entry Outlook for Wegovy

Wegovy 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 seven 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 a Trial

Drug patent expirations by year for WEGOVY
Drug Prices for WEGOVY

See drug prices for WEGOVY

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for WEGOVY
Generic Entry Date for WEGOVY*:
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 WEGOVY

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

SponsorPhase
Merck Sharp & Dohme LLCPhase 2
Neurobiology Research UnitPhase 2
Psychiatric Centre RigshospitaletPhase 2

See all WEGOVY clinical trials

Pharmacology for WEGOVY
Paragraph IV (Patent) Challenges for WEGOVY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
WEGOVY Injection semaglutide 0.25 mg/0.5 mL 0.5 mg/0.5 mL 1 mg/0.5 mL 1.7 mg/0.75 mL 2.4 mg/0.75 mL 215256 1 2022-10-20

US Patents and Regulatory Information for WEGOVY

WEGOVY is protected by six US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of WEGOVY 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 WEGOVY

GLP-1 compositions and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR WEIGHT MANAGEMENT

GLP-1 compositions and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR WEIGHT MANAGEMENT


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR WEIGHT MANAGEMENT

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

Acylated GLP-1 compounds
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: METHOD FOR WEIGHT MANAGEMENT ACCORDING TO A DOSE ESCALATION SCHEDULE

FDA Regulatory Exclusivity protecting WEGOVY

NEW PRODUCT
Exclusivity Expiration: ⤷  Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

USE OF SEMAGLUTIDE 1.7 MG SUBCUTANEOUS WEEKLY AS AN ADDITIONAL MAINTENANCE DOSE
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 WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-005 Jun 4, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-004 Jun 4, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-004 Jun 4, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novo WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256-004 Jun 4, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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

EU/EMA Drug Approvals for WEGOVY

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 WEGOVY

When does loss-of-exclusivity occur for WEGOVY?

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 WEGOVY around the world.

Country Patent Number Title Estimated Expiration
Australia 2021207313 Pharmaceutical formulations ⤷  Try a Trial
Mexico 2014014946 USO DE PEPTIDOS GLP-1 DE ACCION PROLONGADA. (USE OF LONG-ACTING GLP-1 PEPTIDES.) ⤷  Try a Trial
Taiwan I783890 ⤷  Try a Trial
Canada 2601784 COMPOSES DE GLP-1 ACYLES (ACYLATED GLP-1 COMPOUNDS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for WEGOVY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1863839 22/2018 Austria ⤷  Try a Trial PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839 CR 2018 00019 Denmark ⤷  Try a Trial PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212
1863839 2018C/016 Belgium ⤷  Try a Trial PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839 2018/017 Ireland ⤷  Try a Trial 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

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.