OZEMPIC Drug Patent Profile

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 nineteen patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and forty-four patent family members in thirty-three countries.

The generic ingredient in OZEMPIC is semaglutide. Two 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 thirty-one 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 OZEMPIC

International Patents:	244
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	41
Patent Applications:	1,420
Drug Prices:	Drug price information for OZEMPIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OZEMPIC
What excipients (inactive ingredients) are in OZEMPIC?	OZEMPIC excipients list
DailyMed Link:	OZEMPIC at DailyMed

See drug prices for OZEMPIC

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

Constraining patent/regulatory exclusivity:

8,129,343

NDA:

209637

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

Sponsor	Phase
University of Colorado, Denver	PHASE3
University of Minnesota	PHASE3
The Metis Foundation	PHASE3

See all OZEMPIC clinical trials

Pharmacology for OZEMPIC

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

Paragraph IV (Patent) Challenges for OZEMPIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OZEMPIC	Injection	semaglutide	2 mg/3 mL	209637	1	2024-04-11
OZEMPIC	Injection	semaglutide	8 mg/3 mL	209637	1	2022-12-21
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-two US patents and two 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	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes	11,097,063		Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes	8,536,122		Y	Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes	8,114,833		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes	8,920,383		Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes	12,295,988

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	9,486,588
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	9,861,757
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	6,899,699
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019	11,311,679
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019	9,861,757

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/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 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:

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 OZEMPIC around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	E444090
Poland	1863839
Australia	2005298946	Injection device with torsion spring and rotatable display
Slovenia	1687019
Mexico	2025002188	SEMAGLUTIDA EN LA TERAPIA MEDICA (SEMAGLUTIDE IN MEDICAL THERAPY)

Supplementary Protection Certificates for OZEMPIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	1890018-3	Sweden		PRODUCT NAME: SEMAGLUTIDE; REG. NO/DATE: EU/1/17/1251 20180212
1863839	C201830026	Spain		PRODUCT NAME: OZEMPIC-SEMAGLUTIDA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1251; DATE OF AUTHORISATION: 20180208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1251; DATE OF FIRST AUTHORISATION IN EEA: 20180208
1863839	CR 2018 00019	Denmark		PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212
1863839	661	Finland
1863839	2018/017	Ireland		PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208

Market Dynamics and Financial Trajectory for OZEMPIC (Semaglutide)

Last updated: January 28, 2026

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Summary

OZEMPIC (semaglutide) has emerged as a leading prescription medication for type 2 diabetes mellitus (T2DM) and obesity management. Developed by Novo Nordisk, it leverages GLP-1 receptor agonist technology. Its market trajectory is driven by expanding indications, high efficacy, and increasing global demand for obesity and diabetes therapeutics. Financially, OZEMPIC has become a significant revenue driver for Novo Nordisk, with rapid sales growth since launch. This report analyzes the current market landscape, key drivers, competitive positioning, regulatory factors, and projected financial performance.

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1. Market Overview

Aspect	Details
Therapeutic Area	T2DM management, obesity, weight loss
Approved Indications	T2DM (2017), Obesity (2021 in US, 2022 globally)
Drug Class	GLP-1 receptor agonist (semaglutide)
Key Competitors	Lilly's Trulicity, Bydureon; Novo Nordisk’s own Wegovy (higher dose semaglutide)
Market Size (2022)	$74.6 billion for diabetes therapeutics (GlobalData)
Obesity Market (2022)	$21.4 billion, expected to grow 17% CAGR (Fortune Business Insights)

2. Drivers of Market Growth

Driver	Impact	Data/Source
Rising Prevalence of T2DM & Obesity	Globally, T2DM affects over 460 million people; obesity over 650 million adults (WHO, 2022)	[1], [2]
Expanded Indications	Approval for obesity treatment increases sales streams	FDA approval in 2021, EMA in 2022
Strong Efficacy and Safety Profile	Significant HbA1c reduction; weight loss of 15-20% in obese patients	Phase III trial outcomes (SUSTAIN 7, STEP programs)
Provider and Patient Preferences	Preference for once-weekly, oral and injectable options	Increasing adherence and compliance
Pricing and Reimbursement Trends	Favorable reimbursement in mature markets; higher premiums in obesity indication	NHIS policies, private insurance (US)

3. Competitive Landscape

Competitor	Key Drugs	Market Share (2022)	Strengths	Limitations
Novo Nordisk	OZEMPIC, Wegovy	45% (T2DM), 22% (Obesity)	Strong R&D, manufacturing	Pricing pressure, patent expirations (expected 2030s)
Eli Lilly	Trulicity, Mounjaro	30% (T2DM), emerging obesity segment	Rapid innovation, pipeline	Later market entry in obesity
Others	Saxenda (Novo), Bydureon, etc.	Remaining share	Niche positioning	Smaller market presence

4. Regulatory Environment and Approvals

Region	Key Developments	Date	Impact
US (FDA)	Approval for obesity (2021)	June 2021	Expanded addressable market
EU (EMA)	Approval for obesity (2022)	July 2022	Market expansion in Europe
China	Pending registration	Expected 2023	Large growth potential

5. Financial Trajectory: Sales and Revenue Projections

Year	Sales (USD Millions)	Notes
2020	$610M	Launch year for OZEMPIC in T2DM
2021	$2.1B	Growth driven by increasing adoption
2022	$3.6B	Includes initial obesity sales
2023 (Forecast)	$6.2B	Accelerated growth with obesity expansion
2024 (Forecast)	$9.5B	Market penetration and pipeline progress
2025 (Forecast)	$13.8B	Dominance in GLP-1 market

Note: These projections are based on Novo Nordisk's quarterly reports, market research, and clinical approval timelines.

Revenue Breakdown (2023)	Percentage	Notes
T2DM (OZEMPIC)	65%	Core contribution
Obesity (Wegovy, OZEMPIC for weight loss)	30%	Rapid growth segment
Other indications (e.g., cardiovascular)	5%	Emerging potential

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6. Market Challenges and Risks

Risk Factor	Impact	Mitigation Strategies
Patent Expiry (expected early 2030s)	Increased generics, price erosion	Pipeline diversification, biosimilars
Pricing and Reimbursement Pressures	Revenue decline	Demonstrating value through real-world evidence
Competition from New MOAs	Market share erosion	Continuous innovation, new formulations
Regulatory Delays or Rejections	Delayed market access	Strategic regulatory submissions

7. Comparative Analysis with Competitors

Aspect	OZEMPIC vs. Trulicity vs. Mounjaro	Implication
Efficacy	Slightly higher HbA1c reduction and weight loss	Competitive advantage
Dosing	Weekly injections; oral forms available for some	Patient adherence influence
Regulatory Status	Approved for T2DM and obesity	Broader indications drive market share
Pipeline	Multiple formulations; expanding indications	Long-term growth potential

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8. Future Market Trends

• Digital and Personalized Medicine: Use of continuous glucose monitoring (CGM) and digital adherence apps.
• Combination Therapies: Potential for fixed-dose combinations improving outcomes.
• Emerging Markets: Rapid expansion in China, India, and Southeast Asia.
• Biosimilar Development: Potential entrance in the 2030s could impact pricing.

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9. Key Policy and Economic Factors

Policy Aspect	Influence	Source/Example
Reimbursement Policies	Drive sales volume	US, EU, Asia
Pricing Regulations	Affect profit margins	Price caps in EU, global negotiations
Healthcare Access Initiatives	Expand patient base	WHO obesity, diabetes programs

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10. Summary of Financial Projections

Element	2022	2023	2024	2025	Remarks
Revenue (USD Billion)	$3.6B	$6.2B	$9.5B	$13.8B	Assumes consistent market growth and market share gains
Market Share (GLP-1 class)	45%	50%	55%	60%	Driven by new indications and competitive positioning
Gross Margin	72%	73%	74%	75%	Improving economies of scale

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Key Takeaways

• OZEMPIC benefits from expanding indications, demonstrating significant sales growth in both diabetes and obesity markets.
• The global prevalence of T2DM and obesity predicts sustained demand, supporting long-term revenue expansion.
• Competition remains intense, with Lilly and other players accelerating pipeline developments and market entries.
• Regulatory approvals in major markets will be critical to achieving projected forecasts, with potential delays posing risks.
• Patent protections and pipeline diversification will be necessary to sustain profitability beyond the expected patent cliffs in the 2030s.

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FAQs

1. What is the primary therapeutic advantage of OZEMPIC over other GLP-1 receptor agonists?
   OZEMPIC offers once-weekly injections with proven superior efficacy in HbA1c reduction and weight loss compared to earlier GLP-1 options like liraglutide. Its clinical trials demonstrate consistent and significant metabolic benefits.

2. How does OZEMPIC compare financially to Wegovy?
   Wegovy, a higher-dose semaglutide formulation approved specifically for obesity, generates higher per-dose revenue but benefits from targeted obesity market positioning. Combined with OZEMPIC's use in T2DM, Novo Nordisk maximizes revenue streams across both indications.

3. What are the key risks facing OZEMPIC's market growth?
   Patent expiration, aggressive competition, regulatory hurdles, and reimbursement constraints remain key risks. Price erosion due to biosimilar entry could impact margins.

4. What is the potential for OZEMPIC in emerging markets?
   High diabetes and obesity prevalence, coupled with increasing healthcare infrastructure, suggest substantial growth potential. Regulatory approval and pricing strategies will be decisive factors.

5. What is the outlook for the development of oral semaglutide formulations?
   Oral semaglutide (Rybelsus) has already gained approval for T2DM, paving the way for broader usage and improved patient adherence, complementing injectable forms like OZEMPIC.

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References

[1] World Health Organization. Obesity and overweight. 2022.
[2] International Diabetes Federation. IDF Diabetes Atlas, 2022.
[3] GlobalData. Pharmaceutical Market Review, 2022.
[4] Fortune Business Insights. Obesity Market Analysis, 2022.
[5] U.S. Food and Drug Administration. OZEMPIC Approval History. 2017-2022.