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MOUNJARO (AUTOINJECTOR) Drug Patent Profile

Which patents cover Mounjaro (autoinjector), and what generic alternatives are available?

Mounjaro (autoinjector) is a drug marketed by Eli Lilly And Co and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and eleven patent family members in forty-four countries.

The generic ingredient in MOUNJARO (AUTOINJECTOR) is tirzepatide. One supplier is listed for this compound. Additional details are available on the tirzepatide profile page.

DrugPatentWatch^® Generic Entry Outlook for Mounjaro (autoinjector)

Mounjaro (autoinjector) will be eligible for patent challenges on May 13, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

Indicators of Generic Entry

Summary for MOUNJARO (AUTOINJECTOR)

International Patents:	111
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	MOUNJARO (AUTOINJECTOR) at DailyMed

Pharmacology for MOUNJARO (AUTOINJECTOR)

Drug Class	GLP-1 Receptor Agonist Glucose-dependent Insulinotropic Polypeptide Receptor Agonist
Mechanism of Action	G-Protein-linked Receptor Interactions Glucagon-like Peptide-1 (GLP-1) Agonists

US Patents and Regulatory Information for MOUNJARO (AUTOINJECTOR)

MOUNJARO (AUTOINJECTOR) is protected by two US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-001	May 13, 2022		RX	Yes	Yes	9,474,780		Y	Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-006	May 13, 2022		RX	Yes	Yes
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-003	May 13, 2022		RX	Yes	Yes	9,474,780		Y	Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-002	May 13, 2022		RX	Yes	Yes	9,474,780		Y	Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-004	May 13, 2022		RX	Yes	Yes
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-003	May 13, 2022		RX	Yes	Yes	11,357,820		Y

EU/EMA Drug Approvals for MOUNJARO (AUTOINJECTOR)

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Mounjaro	tirzepatide	EMEA/H/C/005620 Mounjaro is indicated for the 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 the populations studied, see sections 4.4, 4.5 and 5.1.	Authorised	no	no	no	2022-09-15

International Patents for MOUNJARO (AUTOINJECTOR)

See the table below for patents covering MOUNJARO (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
Moldova, Republic of	3242887
Dominican Republic	P2017000153	COMPUESTOS CO-AGONISTAS DE GIP Y GLP-1
European Patent Office	3810201	COMPOSITIONS AGONISTES GIP/GLP1 (GIP/GLP1 AGONIST COMPOSITIONS)
Ukraine	110026	ПРИСТРІЙ ДЛЯ АВТОМАТИЧНОГО ВИКОНАННЯ ІН'ЄКЦІЇ З МЕХАНІЗМОМ ЗАТРИМКИ, ЯКИЙ ВКЛЮЧАЄ В СЕБЕ ПЕРЕСУВАЛЬНИЙ ЕЛЕМЕНТ ПОДВІЙНОГО ПРИЗНАЧЕННЯ
South Korea	101419160
Denmark	2542280

Supplementary Protection Certificates for MOUNJARO (AUTOINJECTOR)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3242887	2023C/506	Belgium		PRODUCT NAME: TIRZEPATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887	LUC00296	Luxembourg		PRODUCT NAME: TIRZEPATIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887	CA 2023 00005	Denmark		PRODUCT NAME: TIRZEPATID OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/22/1685 20220919
3242887	C03242887/01	Switzerland		PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022
3242887	PA2023504	Lithuania		PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915
3242887	122023000012	Germany		PRODUCT NAME: TIRZEPATIDE UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/22/1685 20220915

MOUNJARO (AUTOINJECTOR) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mounjaro (Autoinjector)

Introduction

Mounjaro, developed by Eli Lilly and Company, is a groundbreaking drug that has been making significant waves in the pharmaceutical industry. Approved for the treatment of type 2 diabetes and more recently for obesity, Mounjaro has become a key growth driver for Lilly. Here, we delve into the market dynamics and financial trajectory of this autoinjector drug.

Rising Demand and Market Growth

The demand for Mounjaro is skyrocketing, driven by its efficacy in treating diabetes and obesity. In Q4 2023, Mounjaro sales reached $2.2 billion, a substantial increase from $279 million in the same period of 2022[3][5].

Key Drivers of Growth

Several factors are contributing to the rapid growth of Mounjaro:

Chronic Disease Prevalence

The increasing incidence of chronic diseases such as diabetes and obesity is a significant driver. As the global population grapples with these conditions, the demand for effective treatments like Mounjaro is on the rise[3].

Patient Preference for Self-Administration

Patients are increasingly preferring self-administration of medications, which autoinjectors like Mounjaro facilitate. This preference is driven by convenience, ease of use, and reduced need for frequent hospital visits[1].

Technological Advancements

Advancements in drug delivery systems, particularly autoinjectors, have enhanced the user experience and efficacy of medications. Mounjaro's autoinjector format is a prime example of this innovation[1].

Financial Performance

The financial performance of Mounjaro has been nothing short of impressive:

Quarterly Revenue

In Q4 2023, Mounjaro sales contributed significantly to Lilly's revenue, which increased by 28% compared to Q4 2022. The U.S. revenue for Lilly jumped 39% to $6.46 billion, largely driven by Mounjaro sales[5].

Annual Projections

For 2024, Mounjaro sales are projected to roughly triple, reaching over $7.2 billion, according to a machine learning/time series forecasting model. This growth is expected to continue, with GlobalData projecting Mounjaro to top Novo Nordisk’s Ozempic in sales by 2027 and emerge as the leading drug in the obesity and diabetes market by 2029[3].

Full-Year Outlook

Lilly has significantly raised its full-year 2024 revenue outlook to a range of $42.4 billion to $43.6 billion, up from the previous forecast of $40.4 billion to $41.6 billion. This increase is largely attributed to the strong performance of Mounjaro and its obesity treatment counterpart, Zepbound[3].

Market Expansion and Geographic Impact

North America

The North American region is a significant market for Mounjaro, driven by substantial investments in the healthcare sector and the increasing prevalence of chronic diseases. The convenience and cost-effectiveness of autoinjectors like Mounjaro are particularly appealing in this region[4].

Asia-Pacific

The Asia-Pacific region is also experiencing rapid growth, fueled by a rising aging population, increased awareness about self-administration benefits, and growing healthcare infrastructure. Countries like India and China are becoming key production and supply hubs due to lower manufacturing costs[1].

Competitive Landscape

Mounjaro operates in a competitive landscape dominated by several major pharmaceutical companies. However, its unique efficacy and the convenience of its autoinjector format have helped it stand out. Key players in the autoinjectors market include AbbVie Inc., Amgen Inc., Becton, Dickinson and Company (BD), and Johnson & Johnson, among others[1].

Challenges and Opportunities

Supply Constraints

Despite its strong growth, Mounjaro faces challenges such as supply constraints that have impacted its availability. Overcoming these constraints is crucial for realizing the full potential of the drug[3].

Regulatory Approvals

Recent regulatory approvals, such as the approval for an obesity indication in November 2023, have opened up new markets for Mounjaro. Continued regulatory support will be essential for its long-term success[3].

Analyst Projections and Future Outlook

Sales Projections

Analysts project that Mounjaro could overtake Novo Nordisk’s semaglutide and potentially become the best-selling drug of all time. The broader market for anti-obesity drugs, including Zepbound, is expected to reach $100 billion per year by 2030, a 16-fold increase from 2023 levels[3].

Market Dominance

GlobalData projects that Mounjaro will top Ozempic in sales by 2027 and emerge as the leading drug in the obesity and diabetes market by 2029, with projected sales of $27 billion that year[3].

"Goldman Sachs projects the broader market for anti-obesity drugs including Zepbound could hit $100 billion per year by 2030, a 16-fold increase from 2023 levels."[3]

Key Takeaways

• Rapid Growth: Mounjaro sales are projected to triple in 2024, driven by its efficacy and patient preference for self-administration.
• Financial Impact: Mounjaro has significantly contributed to Lilly's revenue growth, with Q4 2023 sales reaching $2.2 billion.
• Market Expansion: The drug is expanding its market presence globally, particularly in North America and the Asia-Pacific region.
• Challenges: Supply constraints need to be addressed to fully realize the drug's potential.
• Future Outlook: Analysts project Mounjaro to become one of the best-selling drugs of all time, with a projected market size of $27 billion by 2029.

FAQs

1. What is Mounjaro used for? Mounjaro (tirzepatide) is used for the treatment of type 2 diabetes and has recently been approved for the treatment of obesity.

2. How has Mounjaro impacted Eli Lilly's revenue? Mounjaro has been a significant growth driver for Eli Lilly, contributing to a 28% increase in revenue in Q4 2023 compared to Q4 2022.

3. What are the key drivers of Mounjaro's growth? The key drivers include the rising incidence of chronic diseases, patient preference for self-administration, and technological advancements in drug delivery systems.

4. What are the projected sales for Mounjaro in 2024? Mounjaro sales are projected to roughly triple in 2024, reaching over $7.2 billion.

5. Which regions are seeing significant growth in Mounjaro sales? The North American and Asia-Pacific regions are experiencing significant growth due to investments in healthcare and increasing awareness about self-administration benefits.

Sources

1. Meditech Insights: Autoinjectors Market is Projected Growth at a CAGR of 14-16% from 2023 to 2028.
2. Lilly Investor Relations: Lilly Reports Fourth-Quarter 2022 Financial Results, Core Business.
3. Drug Discovery Trends: Eli Lilly's Mounjaro sales projected to triple in 2024.
4. GlobeNewswire: Auto-Injectors Market revenue to surpass USD 33 Billion by 2036.
5. PR Newswire: Lilly Reports Strong Fourth-Quarter 2023 Financial Results and Provides 2024 Guidance.