WEGOVY Drug Patent Profile

Which patents cover Wegovy, and what generic alternatives are available?

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

Summary for WEGOVY

International Patents:	122
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	12
Patent Applications:	938
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for WEGOVY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for WEGOVY
What excipients (inactive ingredients) are in WEGOVY?	WEGOVY excipients list
DailyMed Link:	WEGOVY at DailyMed

See drug prices for WEGOVY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for WEGOVY

NDA:

215256

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 2
Psychiatric Centre Rigshospitalet	Phase 2
Neurobiology Research Unit	Phase 2

See all WEGOVY clinical trials

Pharmacology for WEGOVY

Drug Class	GLP-1 Receptor Agonist
Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Anatomical Therapeutic Chemical (ATC) Classes for WEGOVY

A10BJ	Glucagon-like peptide-1 (GLP-1) analogues
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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.

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

FDA Regulatory Exclusivity protecting WEGOVY

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
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-004	Jun 4, 2021		RX	Yes	Yes
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-004	Jun 4, 2021		RX	Yes	Yes
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-004	Jun 4, 2021		RX	Yes	Yes
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-004	Jun 4, 2021		RX	Yes	Yes			Y	Y

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

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

Austria

Brazil

Canada

China

Denmark

European Patent Office

Germany

Hungary

Israel

Japan

Mexico

Netherlands

Norway

Poland

Portugal

Russian Federation

South Africa

South Korea

Spain

Taiwan

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
Canada	2601784	COMPOSES DE GLP-1 ACYLES (ACYLATED GLP-1 COMPOUNDS)
Mexico	2022009844	COMPOSICIONES Y USOS DEL PEPTIDO SIMILAR AL GLUCAGON-1 (GLP-1). (GLP-1 COMPOSITIONS AND USES THEREOF.)
Peru	20221575	FORMULACIONES FARMACEUTICAS
Mexico	2022009523	FORMULACIONES FARMACEUTICAS. (PHARMACEUTICAL FORMULATIONS.)
Netherlands	300936

Supplementary Protection Certificates for WEGOVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	661	Finland
1863839	18C1017	France		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	132018000000262	Italy		PRODUCT NAME: SEMAGLUTIDE(OZEMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1251, 20180212
1863839	1890018-3	Sweden		PRODUCT NAME: SEMAGLUTIDE; REG. NO/DATE: EU/1/17/1251 20180212
1863839	300936	Netherlands		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208