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 twenty patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and five patent family members in twenty-eight 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 twenty-five 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:	205
US Patents:	20
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	31
Patent Applications:	702
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
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 3
University Health Network, Toronto	Phase 2
University of Colorado, Denver	Phase 3

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-three US patents and one FDA Regulatory Exclusivity.

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	209637-002	Apr 9, 2019		RX	Yes	Yes	10,335,462
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes	9,861,757		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes	8,684,969		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes	11,097,063		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes	10,220,155		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes	9,687,611		Y

Expired US Patents for OZEMPIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022	7,762,994
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017	6,899,699
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019	8,672,898
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022	7,762,994
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019	7,762,994
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019	6,899,699

EU/EMA Drug Approvals for OZEMPIC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
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
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

International Patents for OZEMPIC

See the table below for patents covering OZEMPIC around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2004290862	Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Croatia	P20200889
Japan	4970282
Japan	5209463
Portugal	1687019
Slovenia	2866825

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	18C1017	France		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	2018/017	Ireland		PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839	22/2018	Austria		PRODUCT NAME: SEMAGLUTID; REGISTRATION 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	SPC/GB18/023	United Kingdom		PRODUCT NAME: SEMAGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/17/1251 (NI) 20180208; UK PLGB 04668/0331 20180208; UK PLGB 04668/0332 20180208; UK PLGB 04668/0333 20180208

Market Dynamics and Financial Trajectory of Ozempic

Market Overview

Ozempic, a glucagon-like peptide-1 (GLP-1) receptor agonist, has become a pivotal player in the pharmaceutical market, particularly in the management of Type 2 diabetes and obesity. Here’s a detailed look at the market dynamics and financial trajectory of Ozempic.

Drivers of Growth

Increasing Prevalence of Obesity and Diabetes

The Ozempic market is driven significantly by the rising prevalence of obesity and Type 2 diabetes globally. The COVID-19 pandemic has exacerbated these issues, with lockdowns and lifestyle changes leading to increased weight gain and related health concerns[1].

Effective Therapeutic Outcomes

Ozempic's efficacy in improving blood sugar control and reducing the risk of cardiovascular events has made it a preferred treatment option. Its dual utility in addressing both diabetes and obesity has further boosted its demand[1].

Legislative Support

Legislative efforts, such as the bipartisan Treat and Reduce Obesity Act, aim to expand Medicare coverage for anti-obesity medications, potentially increasing access and driving market growth[1].

Technological Innovations and R&D

Advancements in research and development, along with new product launches, are expected to enhance the therapeutic landscape for obesity and diabetes management. Companies like Novo Nordisk, Eli Lilly, and Pfizer are working on oral versions of GLP-1s to expand treatment options[3].

Restraints and Challenges

Supply Constraints

Despite the growing demand, Ozempic has faced supply constraints and related drug shortage notifications across various geographies. This has been a significant challenge for the company, necessitating strategic management of demand and distribution[2].

Side Effects and Safety Concerns

Concerns about side effects such as gastrointestinal issues and potential links to suicide risk are under scrutiny. These safety concerns could impact adoption rates and overall market growth[3].

High Costs and Insurance Coverage

The high cost of Ozempic and uncertainties about insurance coverage are significant barriers to widespread adoption. These factors contribute to the cautious approach of investors and consumers alike[3].

Market Segmentation

Geographic Distribution

The North American region holds the largest market share for Ozempic, driven by the high prevalence of diabetes and obesity in this region. Other significant markets include Europe and the Asia-Pacific region[1].

Product Performance

Ozempic sales have seen substantial growth, with a 42% increase in sales measured in Danish kroner and a 43% increase at constant exchange rates in the first quarter of 2024. This growth has been driven by both North American and international operations[2].

Financial Performance

Revenue Growth

Novo Nordisk reported a significant increase in revenue, with sales of Ozempic and its sister drug Wegovy rising by 25% year-over-year. Sales in North America specifically increased by 34%[5].

Earnings and Profitability

The company's net profit for the first quarter of 2024 was 25.41 billion Danish kroner ($3.65 billion), exceeding analysts' estimates. Diluted earnings per share also rose, reflecting the strong demand for GLP-1-based treatments[5].

Full-Year Guidance

Novo Nordisk has raised its full-year guidance, projecting sales growth between 19% to 27% at constant exchange rates. This is slightly up from the previous projection of 18% to 26%, indicating continued strong demand for Ozempic and Wegovy[5].

Impact on Other Industries

Retail and Consumer Goods

Ozempic's influence extends beyond the healthcare sector, impacting various retail and consumer goods industries. Companies in sectors such as food, snacks, clothing, and airlines are feeling the effects of reduced demand due to the weight loss associated with Ozempic[3][4].

Healthcare Sector

The demand for bariatric surgery devices and diabetes equipment is also being affected, as patients opt for pharmaceutical solutions like Ozempic over surgical interventions[3].

Competitive Landscape

Key Players

Novo Nordisk A/S is the dominant player in the Ozempic market, with competitors like Eli Lilly also reporting significant growth in their own weight-loss drugs, such as Mounjaro and Zepbound[5].

Market Concentration

The market is characterized by a lack of generic alternatives, which has allowed Novo Nordisk to maintain a strong market position. However, the market concentration is low, indicating room for new entrants and competition[1].

Future Outlook

Continued Growth

The Ozempic market is expected to experience robust growth, driven by the increasing burden of obesity and diabetes, alongside supportive policy and healthcare initiatives. The market size is projected to reach USD 16.5 billion by 2029, growing at a CAGR of greater than 8% from 2024 to 2029[1].

Innovations and Expansions

Novo Nordisk's acquisition of Catalent manufacturing sites and investments in boosting production are expected to address supply constraints and serve more patients in the future. The development of oral GLP-1s and other innovations will further expand treatment options and drive market growth[2][5].

Key Takeaways

• Market Growth: The Ozempic market is expected to grow significantly, driven by increasing obesity and diabetes rates.
• Financial Performance: Novo Nordisk has reported strong revenue and profit growth due to high demand for Ozempic.
• Supply Challenges: Despite growth, supply constraints remain a significant challenge.
• Impact on Industries: Ozempic affects various industries beyond healthcare, including retail and consumer goods.
• Competitive Landscape: Novo Nordisk dominates the market, but competition from other pharmaceutical companies is increasing.

FAQs

What is the current market size of Ozempic?

The Ozempic market size is estimated at USD 10.99 billion in 2024[1].

What is the projected growth rate of the Ozempic market?

The Ozempic market is expected to grow at a CAGR of greater than 8% from 2024 to 2029[1].

Which region holds the largest market share for Ozempic?

The North American region currently holds the largest market share for Ozempic[1].

What are the main drivers of growth for the Ozempic market?

The main drivers include increasing obesity and diabetes rates, legislative support, and technological innovations[1][3].

How has Ozempic impacted other industries?

Ozempic has impacted industries such as food, snacks, clothing, and airlines due to reduced demand resulting from weight loss[3][4].

Sources

1. Mordor Intelligence: Ozempic Market Size (2024 - 2029) - Mordor Intelligence
2. Globenewswire: Financial report for the period 1 January 2024 to 31 March 2024
3. Axios: Ozempic is upending markets, despite unknowns
4. Ankura: Beyond the Prescription: Ozempic's Influence on Health, Retail, and Consumer Behavior
5. Investopedia: Novo Nordisk's Earnings Beat Estimates on Surging Demand for Its Weight-Loss Drugs