WEGOVY Drug Patent Profile

Which patents cover Wegovy, and when can generic versions of Wegovy launch?

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

This drug has one hundred and eighty-two patent family members in thirty-three 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 sixteen 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:	182
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	26
Patent Applications:	1,408
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
University of Colorado, Denver	PHASE3
University of Minnesota	PHASE3
The Metis Foundation	PHASE3

See all WEGOVY clinical trials

Pharmacology for WEGOVY

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

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 nine US patents and four 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.

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	215256-004	Jun 4, 2021		RX	Yes	Yes			Y	Y
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-003	Jun 4, 2021		RX	Yes	Yes
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-005	Jun 4, 2021		RX	Yes	Yes			Y
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-004	Jun 4, 2021		RX	Yes	Yes
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-005	Jun 4, 2021		RX	Yes	Yes

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/005422Wegovy 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/004174Treatment 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/004953Rybelsus 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:

Canada

Mexico

Russian Federation

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	3082033
Israel	314181
Chile	2022002084
Portugal	2322546
Taiwan	202304501	GLP-1 compositions and uses thereof

Supplementary Protection Certificates for WEGOVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	22/2018	Austria		PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	2018C/016	Belgium		PRODUCT NAME: OZEMPIC - SEMAGLUTIDE; AUTHORISATION NUMBER AND DATE: EU/1/17/1251 20180212
1863839	CR 2018 00019	Denmark		PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212
1863839	C01863839/01	Switzerland		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018
1863839	300936	Netherlands		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208

Market Dynamics and Financial Trajectory for WEGOVY (Semaglutide)

Last updated: December 25, 2025

Summary

WEGOVY (semaglutide) represents a pivotal advancement in the treatment of obesity and type 2 diabetes, with its groundbreaking efficacy and expanding indications fueling robust market growth. This analysis explores the evolving landscape of WEGOVY, examining key market drivers, competitive positioning, financial forecasts, regulatory factors, and strategic considerations. With sales projected to reach billions globally within the next five years, understanding its market dynamics is vital for stakeholders aiming to navigate this high-stakes therapeutic area.

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What is WEGOVY?

WEGOVY (semaglutide), developed by Novo Nordisk, is a GLP-1 receptor agonist initially approved for type 2 diabetes and later gaining approval for chronic weight management. Its mechanism involves mimicking incretin hormones to enhance insulin secretion, reduce glucagon levels, and suppress appetite, leading to significant weight loss and glycemic improvements.

Key Specifications

Attribute	Details
Active Ingredient	Semaglutide
Formulation	Subcutaneous injection (single weekly dose)
Indications	Type 2 diabetes, obesity, weight management
Approved Regions	U.S., EU, Japan, other major markets
Launch Year	2021 for diabetes; 2021 for obesity in the US; subsequent approvals ongoing

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Market Drivers for WEGOVY

1. Expanding Indications and Unmet Medical Needs

The approvals for obesity management, notably the FDA's expanded indication in June 2021, have created significant commercial opportunities. Obesity affects over 650 million globally (WHO), with a rising prevalence expanding the patient pool for WEGOVY.

2. Efficacy and Safety Profile

Clinical trials demonstrate substantial weight loss—average of 15-20% body weight reduction—surpassing many competitors. The SCALE and STEP studies support its favorable benefit-risk profile, boosting physician confidence.

3. Competitive Landscape and Differentiators

While other GLP-1 RAs exist (e.g., liraglutide, dulaglutide), WEGOVY's longer-acting formulation and superior efficacy in weight reduction distinguish it. Its once-weekly administration enhances patient adherence.

4. Regulatory Approvals and Policy Environment

Global regulators are increasingly approving GLP-1 RAs for obesity. Policies favor pharmacological interventions for weight management, especially with evidence demonstrating cardiovascular benefits (e.g., STEP trials showing reduced CV risk in obesity).

5. Rising Healthcare Expenditure and Obesity Epidemic

Growth in healthcare spending, particularly in managing obesity-related comorbidities, supports market expansion. Countries like the U.S., EU, and China prioritize innovative treatments.

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Competitive Landscape

Competitors	Key Features	Market Share (Estimate)	Notable Products
Novo Nordisk	WEGOVY (semaglutide), Wegovy (obesity indication)	Dominant in GLP-1 space; ~65-70% global market share (2023)	Ozempic, Rybelsus
Eli Lilly	Tirzepatide (dual GIP/GLP-1 RA)	Emerging competitor; expanding market share	Mounjaro
Others	Liraglutide, dulaglutide, semaglutide (other formulations)	Remaining share, growing slowly	Victoza, Trulicity

Market positioning relies heavily on clinical efficacy, formulary coverage, manufacturing capacity, and regulatory approvals.

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Financial Trajectory and Sales Forecast

1. Historical Revenue Trends

Year	Sales (USD Billion)	Notes
2021	$1.2 billion	Launch year, initial uptake
2022	$3.1 billion	Rapid growth driven by obesity indication
2023	$5.4 billion	Market expansion, global uptake

2. Projected Sales (2024-2028)

Year	Projected Sales (USD Billion)	Growth Rate	Key Assumptions
2024	$8.5 billion	57%	Continued approval in new markets, increased adoption
2025	$12.2 billion	44%	Expanded payer coverage, enhanced physician acceptance
2026	$16.8 billion	38%	Entry into additional markets (e.g., China)
2027	$22.4 billion	33%	Extended indications, combination therapies
2028	$28.7 billion	28%	Market saturation minimal, heightened awareness

3. Revenue Breakdown by Indication

Indication	Revenue Share (2023)	Forecast (2028)	Notes
Type 2 Diabetes	55%	30%	Growth in diabetes market but plateauing in some regions
Obesity/Weight Management	45%	70%	Rapid expansion driven by obesity approval

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Regulatory and Policy Factors

1. FDA and EMA Approvals

• FDA (June 2021): Approved WEGOVY for chronic weight management
• EMA (September 2021): Similar authorization
• Japan and China: Approvals pending or recent

2. Price and Reimbursement Policies

Pricing varies, with US list prices around $1,350/month, but negotiations, rebates, and insurance coverage influence actual revenues. Global reimbursement policies significantly impact market access.

3. Healthcare Initiatives

Policies encouraging obesity management and preventive care are fostering demand. Notably, the US CDC promotes pharmacotherapy alongside lifestyle interventions.

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Strategic Considerations and Risks

Risk Factor	Impact	Mitigation Strategies
Regulatory Delays	Slower market penetration	Early engagement and regulatory intelligence
Competitive Market Entry	Erodes market share	Continuous innovation, differentiated positioning
Pricing and Reimbursement Challenges	Cap limits revenue growth	Value-based pricing strategies
Supply Chain Disruptions	Affects availability and revenue	Diversified manufacturing, inventory management
Pricing Pressure and Biosimilars	Future lower margins	Patents, lifecycle management, new indications

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Deep Dive: Comparing WEGOVY with Key Competitors

Parameter	WEGOVY (Semaglutide)	Mounjaro (Tirzepatide)	Victoza (Liraglutide)
Approval Year	2021 (obesity); 2017 (diabetes)	2022 (diabetes), 2023 (obesity indications)	2010 (diabetes)
Dosing Frequency	Weekly	Weekly	Daily
Weight Loss Efficacy	Up to 20% reduction	Up to 22-25% reduction	Up to 6-8% reduction
Market Penetration	Rapid expansion, dominant in obesity	Growing, potential game-changer	Slower uptake, older product
Side Effect Profile	Nausea, vomiting, rare pancreatitis	Similar, with some differences in GI effects	Similar, with less efficacy in weight loss

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Market Outlook and Future Opportunities

• Expanding Indications: Heart failure, non-alcoholic fatty liver disease (NAFLD), and chronic kidney disease.
• Combination Therapies: Dual or triple pathway agents to enhance efficacy.
• Geographic Expansion: Entry into emerging markets (China, India, Brazil).
• Digital Health Integration: Telemedicine, patient adherence programs.

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Key Takeaways

• WEGOVY's launch revolutionized obesity pharmacotherapy, capturing significant market share within two years.
• Rapid sales growth is projected to continue, driven by expanding indications and global approval.
• Competitive differentiation, regulatory environment, and reimbursement policies heavily influence financial trajectories.
• Novo Nordisk's strategic focus on innovation, global market access, and clinical evidence underpin current and future success.
• Risks remain related to regulatory hurdles, pricing pressures, and market saturation, necessitating proactive strategic planning.

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FAQs

1. What factors are driving WEGOVY's market growth?
Increasing obesity prevalence, proven efficacy, favorable safety profile, expanded indications, and supportive regulatory policies are primary drivers.

2. How does WEGOVY compare financially to competitors like Mounjaro?
While WEGOVY dominates the obesity market, Mounjaro shows promise due to its dual mechanism offering superior glycemic control and weight loss, potentially capturing significant market share.

3. What are the key regulatory hurdles for WEGOVY?
While currently approved in major markets, future approvals in emerging economies and indications like NASH or cardiovascular outcomes remain critical.

4. How do pricing and reimbursement impact WEGOVY’s financial trajectory?
High list prices necessitate negotiations; payer coverage, prior authorizations, and health economics evaluations directly influence access and revenue.

5. What is the long-term outlook for WEGOVY’s market?
Strong, with anticipated sustained growth fueled by further indications, global expansion, and advances in combination therapies, barring unforeseen regulatory or competitive disruptions.

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Sources:
[1] Novo Nordisk Annual Reports (2021–2023)
[2] FDA Approvals Database (2021–2023)
[3] World Health Organization (WHO) Reports on Obesity (2022)
[4] Clinical Trials Database for STEP and SCALE studies (2021–2023)
[5] Market Research by EvaluatePharma (2023)