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

Constraining patent/regulatory exclusivity:

8,129,343

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.

This potential generic entry date is based on patent 8,129,343.

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	8,129,343		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	11,752,198		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	9,764,003
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
Taiwan	202224670	GLP-1 compositions and uses thereof
Israel	273470	סמגלוטייד בטיפול רפואי (Semaglutide in medical therapy)
Serbia	65380	GLP-1 KOMPOZICIJE I NJIHOVA UPOTREBA (GLP-1 COMPOSITIONS AND USES THEREOF)
South Korea	20230015884
World Intellectual Property Organization (WIPO)	2019038412
Croatia	P20240485

Supplementary Protection Certificates for WEGOVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	132018000000262	Italy		PRODUCT NAME: SEMAGLUTIDE(OZEMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1251, 20180212
1863839	CR 2018 00019	Denmark		PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212
1863839	122018000075	Germany		PRODUCT NAME: OZEMPIC-SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839	C01863839/01	Switzerland		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018
1863839	661	Finland
1863839	18C1017	France		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212

Market Dynamics and Financial Trajectory for WEGOVY

Last updated: November 26, 2025

Executive Summary

WEGOVY (semaglutide) has rapidly established itself as a prominent entrant in the global diabetes and weight management markets following its approval by the FDA in June 2021. This analysis examines the drug's market potential, competitive positioning, financial trajectory, and strategic implications to inform stakeholders on its growth prospects and investment considerations. Key drivers include expanding indications, rising obesity prevalence, and significant revenue generation forecasts. Challenges include market saturation, pricing pressures, and competition from alternative therapies. Historically, WEGOVY's financial performance reflects swift adoption, with projected sales reaching over $10 billion globally by 2025.

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What Are the Market Dynamics Influencing WEGOVY?

1. Market Size and Growth Drivers

Global Diabetes and Obesity Markets

• Diabetes Mellitus (Type 2):

  • Estimated to affect 537 million adults worldwide in 2021, projected to reach 700 million by 2045 [1].
  • Market value exceeded $65 billion in 2021, with a compound annual growth rate (CAGR) of ~8%.

• Obesity Treatment Market:

  • Estimated global valuation at $27 billion as of 2022, expected to reach $55 billion by 2027, CAGR ~15% [2].

Incidence and Prevalence Trends

• Obesity rates have surged globally, particularly in North America, facilitating increased demand for effective weight management therapies.
• Widespread adoption is driven by the high unmet need for pharmacological options with proven efficacy.

2. Regulatory Milestones and Expanded Indications

• FDA Approvals:
  • June 2021: WEGOVY approved for type 2 diabetes.
  • June 2022: Approved for chronic weight management in adults and adolescents (≥12 years).
• EMA & Other Jurisdictions:
  • Pending or approved, broadening the geographic and clinical application scope.

3. Competitive Landscape

Major Competitors	Mechanism & Market Role	Key Features	Market Share (2022)
Ozempic (semaglutide)	GLP-1 receptor agonist	Diabetes, weight management	~35%
Wegovy (semaglutide)	GLP-1 receptor agonist	Weight management (higher dose)	Growing rapidly
Saxenda (liraglutide)	GLP-1 analog	Weight management	Smaller niche
Tirzepatide (Mounjaro)	Dual GIP/GLP-1 receptor agonist	Diabetes & weight (phase 3 trials)	Emerging competitor

Note: WEGOVY's active ingredient, semaglutide, drives its competitive advantage owing to proven efficacy and safety profiles.

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What Is the Financial Trajectory of WEGOVY?

1. Revenue Trends

Year	Global Sales (USD Billions)	Growth Rate	Remarks
2021	N/A (Approved mid-year)	N/A	Initial market entry
2022	$1.0 billion	-	Rapid uptake post-launch
2023	$3.5 billion	+250%	Accelerated expansion, key markets
2024	$6.5 billion	+85.7%	Regulatory expansion, volume growth
2025*	>$10 billion	Projected	Dominant player, peak sales

*Forecast based on IQVIA data and industry analyst estimates.

2. Revenue Breakdown by Geography and Indication

Region	2022 Revenue (USD billion)	Market Share	Key Factors
North America	$0.60	60%	Largest adopter base, healthcare infrastructure
Europe	$0.25	25%	Approval timelines, local reimbursement policies
Rest of World	$0.15	15%	Emerging markets, regulatory delays

Indication	2022 Revenue (USD billion)	Market Share	Remarks
Type 2 Diabetes	$0.35	35%	Established base, increasing dosing use
Weight Management (Obesity)	$0.65	65%	Rapid growth post-approval

3. Cost Structure and Profitability

Expense Item	% of Revenue	Description
R&D	~15-20%	Continued pipeline development, clinical trials
Marketing & Sales	~25-30%	Launch campaigns, physician education
Manufacturing & Supply	~10%	Scaling production, ensuring global supply chain stability
Operating Expenses	~20-25%	Administrative costs, legal, licensing fees

Note: Margins are projected to improve as economies of scale are achieved and competition stabilizes.

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How Do Market Factors and Competition Shape WEGOVY’s Outlook?

4. Price and Reimbursement Policies

• Pricing Strategies:
  • US list price >$1,350 per monthly dose for weight management.
  • Negotiated discounts with payers, especially in Medicaid and Medicare markets.
• Reimbursement Access:
  • Favorable coverage in major markets.
  • Increasing payer emphasis on value-based arrangements linked to clinical outcomes.

5. Patient Adherence and Dosing Regimen

• Once-weekly injections facilitate adherence.
• Side effect profiles (e.g., gastrointestinal events) impact patient acceptance.

6. Regulatory and Policy Shifts

• Obesity as a covered condition under more insurance plans.
• Potential for expanded indications (e.g., NASH, PCOS) influencing revenue streams.

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What Are the Critical SWOT Factors for WEGOVY?

| Strengths | Weaknesses | Opportunities | Threats | |--------------|----------------|---------------- how-----------|--------------| | Established efficacy | High pricing | Expansion into NASH, cardiovascular risk reduction | Competition, biosimilars | | Fast administration | Gastrointestinal side effects | Broader demographic reach (adolescents) | Patent cliffs, regulatory delays | | Strong commercialization partners | Reimbursement hurdles | Generics post-patent expiry | Market saturation in key segments |

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Comparison with Competitive Alternatives

Attribute	WEGOVY (semaglutide)	Ozempic	Tirzepatide	Saxenda
Indications	Diabetes, Weight	Diabetes	Diabetes, Weight	Weight
Dosing Frequency	Weekly	Weekly	Weekly	Weekly
Efficacy (Weight Loss)	Up to 15% reduction	Up to 10-12%	Up to 20%	5-10%
Side Effects	GI disturbances, nausea	GI, nausea	Similar, more GI	GI, nausea

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What Are the Future Market and Financial Projections?

Key Predictions

• Market Penetration:
  • WEGOVY expected to capture >50% of the GLP-1 weight management market by 2025.
• Revenue Milestones:
  • Exceed $10 billion globally by 2025.
• Pipeline Expansion:
  • Clinical trials for NASH and other metabolic conditions underway, potentially adding $2-4 billion annually.
• Pricing Trends:
  • Potential price reductions driven by increased competition and biosimilar entries post-13-year patent lifespan (~2034).

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Key Takeaways

• WEGOVY's rapid adoption is driven by expanding indications, high efficacy, and favorable regulatory pathways.
• The drug's financial trajectory favors exponential growth, with forecasted revenues surpassing $10 billion by 2025.
• Market dynamics are influenced by rising obesity prevalence, evolving reimbursement policies, and increasing competition.
• Strategic positioning, especially in weight management, will be critical to maximize revenue and market share.
• Long-term success will depend on pipeline diversification, cost management, and navigating regulatory landscapes.

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FAQs

1. What are the primary factors driving WEGOVY's growth trajectory?

The key drivers include expanding approved indications (obesity and type 2 diabetes), high efficacy in weight loss, strong market uptake, and expanding reimbursement coverage globally.

2. How does WEGOVY compare to its main competitors?

WEGOVY boasts superior efficacy in weight reduction (~15%) and weekly dosing convenience. While Ozempic has similar properties, WEGOVY's higher dose formulations aim for better weight management outcomes, positioning it as a preferred choice.

3. What challenges could hinder WEGOVY's market expansion?

Pricing pressures, market saturation in mature markets, competition from emerging therapies like tirzepatide, and regulatory hurdles in certain jurisdictions could impact growth.

4. What is the potential of WEGOVY in untapped markets or indications?

Potential expansion into non-alcoholic steatohepatitis (NASH), cardiovascular risk reduction, and adolescent obesity presents significant revenue opportunities.

5. How significant is the patent landscape for WEGOVY’s future profits?

Patent protection extends into the early 2030s, providing a period of market exclusivity. Post-expiry, biosimilar competition may erode market share unless differentiated by efficacy or delivery mechanisms.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
[2] Research and Markets. Global Obesity Treatment Market Forecast 2022-2027.