MOUNJARO Drug Patent Profile

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

Mounjaro 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 is tirzepatide. One supplier is listed for this compound. Additional details are available on the tirzepatide profile page.

DrugPatentWatch^® Generic Entry Outlook for Mounjaro

Mounjaro 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 5, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MOUNJARO

International Patents:	111
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	3
Drug Prices:	Drug price information for MOUNJARO
What excipients (inactive ingredients) are in MOUNJARO?	MOUNJARO excipients list
DailyMed Link:	MOUNJARO at DailyMed

See drug prices for MOUNJARO

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

Constraining patent/regulatory exclusivity:

9,474,780

NDA:

215866

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 MOUNJARO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Vanderbilt University Medical Center	Phase 2
University Health Network, Toronto	Phase 2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 4

See all MOUNJARO clinical trials

Pharmacology for MOUNJARO

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

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

This potential generic entry date is based on patent 9,474,780.

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
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-005	May 13, 2022		RX	Yes	Yes	11,357,820		Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-004	May 13, 2022		RX	Yes	Yes	9,474,780		Y	Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-005	May 13, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for MOUNJARO

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

When does loss-of-exclusivity occur for MOUNJARO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Finland

France

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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 MOUNJARO 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)

Supplementary Protection Certificates for MOUNJARO

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

MOUNJARO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Mounjaro

Introduction

Eli Lilly's Mounjaro (tirzepatide) has been making significant waves in the pharmaceutical industry, particularly in the treatment of type 2 diabetes and obesity. Here, we delve into the market dynamics and financial trajectory of this groundbreaking drug.

Explosive Sales Growth

Mounjaro has experienced unprecedented sales growth. In the third quarter of 2022, the drug generated $187.3 million in sales, which skyrocketed to $1.4 billion in the same period of 2023. This exponential growth continued, with Q3 2024 sales reaching $3.11 billion globally, and $2.38 billion in the U.S.[2].

Supply Chain Challenges

Despite the robust demand, Eli Lilly has faced significant supply chain challenges. The company has been struggling to keep up with the demand, leading to intermittent delays in filling orders and a tight supply of the medication throughout most of 2023. To address this, Lilly has invested heavily in expanding its manufacturing capacity, including a $450 million investment in its Research Triangle Park facility and an additional $1.6 billion in new manufacturing sites in Indiana[1].

Manufacturing Expansion

Lilly is committed to doubling the production of Mounjaro by the end of the year. The company's efforts to bolster manufacturing capacity are crucial in meeting the strong demand and mitigating supply constraints. Anat Ashkenazi, Lilly's chief financial officer, emphasized the progress being made on the manufacturing expansion agenda, despite the ongoing tight supply issues[1].

Market Impact and Competition

Mounjaro's novel dual mechanism of action has positioned it as a key player in the market, challenging existing industry leaders like Novo Nordisk's Wegovy (semaglutide) and Ozempic. GlobalData predicts that Mounjaro will top Ozempic in sales by 2027 and become the leading drug in the obesity and diabetes market by 2029, with projected sales of $27 billion that year[4].

Clinical Value and Durability

The drug's clinical value extends beyond its immediate sales figures. Mounjaro has shown promising results in supporting long-term weight loss, potentially outperforming other medications in this regard. Mike Mason, the president of Lilly Diabetes, highlighted that Mounjaro's persistency among patients is tracking higher than those started on Trulicity and Ozempic, although it is too early to project the average length of therapy[1].

Regulatory Approvals and Future Indications

Mounjaro has received Fast Track designation from the FDA for the treatment of obesity, a significant step towards expanding its indications. The drug's potential in this area is substantial, with analysts projecting peak sales of $68.7 billion[1].

Financial Performance

The financial impact of Mounjaro on Eli Lilly is profound. For Q3 2024, Mounjaro's revenue contributed significantly to Lilly's overall revenue growth of 20% year-over-year. The company's total revenue for Q3 2024 was $11.439 billion, up from $9.498 billion in Q3 2023. For the full year 2024, Lilly has raised its revenue outlook to a range of $42.4 billion to $43.6 billion, driven largely by Mounjaro's success[2].

Impact on Eli Lilly's Earnings

Mounjaro's sales have been the single biggest growth driver for Lilly. In Q4 2023, Mounjaro sales reached $2.2 billion, a significant increase from $279 million in the same period of 2022. This growth has led to a substantial increase in Lilly's earnings per share, with non-GAAP earnings per share for Q3 2024 standing at $1.18, up from $0.10 in Q3 2023[2][5].

Market Projections

GlobalData projects that Mounjaro's sales revenue will more than double compared to Wegovy, reaching an impressive $34 billion by 2029. This growth is expected to significantly shift market dynamics in Eli Lilly's favor, positioning the company as a leader in the metabolic disease market[3].

Competitive Landscape

Mounjaro's success is part of a broader strategy by Eli Lilly to dominate the pharmaceutical market. Alongside Mounjaro, Lilly's donanemab for early symptomatic Alzheimer’s disease is also poised to challenge existing treatments and contribute to the company's earnings growth. Eleni Tokali, a Pharma Analyst at GlobalData, notes that these drugs represent not only robust sales opportunities but also a chance for Eli Lilly to outperform its competitors[3].

Key Takeaways

• Rapid Sales Growth: Mounjaro has seen explosive sales growth, from $187.3 million in Q3 2022 to $3.11 billion in Q3 2024.
• Supply Chain Challenges: Despite strong demand, supply constraints have led to intermittent delays and tight supply.
• Manufacturing Expansion: Lilly is investing heavily to double production and meet demand.
• Market Impact: Mounjaro is challenging industry leaders and projected to become the top-selling drug in its category by 2029.
• Clinical Value: The drug shows promising long-term weight loss results and higher patient persistency compared to competitors.
• Financial Performance: Mounjaro is driving significant revenue and earnings growth for Eli Lilly.

FAQs

Q: What is Mounjaro, and how is it used?

Mounjaro (tirzepatide) is a medication developed by Eli Lilly for the treatment of type 2 diabetes and, potentially, obesity. It works through a dual mechanism of action, targeting both GLP-1 and GIP receptors.

Q: Why is Mounjaro experiencing supply chain issues?

The high demand for Mounjaro has outpaced Eli Lilly's production capacity, leading to intermittent delays and tight supply. The company is investing in manufacturing expansion to address these issues.

Q: How does Mounjaro compare to other diabetes and obesity treatments?

Mounjaro is projected to outperform competitors like Novo Nordisk's Wegovy and Ozempic in sales by 2027 and become the leading drug in its category by 2029. It also shows better long-term weight loss results compared to other medications.

Q: What are the financial projections for Mounjaro?

Analysts project that Mounjaro could generate peak sales of $68.7 billion and reach $34 billion in sales by 2029, significantly contributing to Eli Lilly's revenue and earnings growth.

Q: What other drugs is Eli Lilly developing to complement Mounjaro?

Eli Lilly is also developing donanemab for early symptomatic Alzheimer’s disease, which is expected to challenge existing treatments and contribute to the company's earnings growth.

Sources

1. Drug Discovery Trends: "Eli Lilly's Mounjaro achieves rapid sales growth in diabetes"
2. Eli Lilly Investor Relations: "Lilly reports Q3 2024 financial results highlighted by strong volume growth"
3. GlobalData: "Eli Lilly's double impact: Mounjaro and Donanemab set to outshine market rivals, says GlobalData"
4. Drug Discovery Trends: "Eli Lilly's Mounjaro sales projected to triple in 2024"
5. Eli Lilly Investor Relations: "Lilly Reports Strong Fourth-Quarter 2023 Financial Results and Provides 2024 Financial Guidance"