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 four patents protecting this drug.

This drug has one hundred and ninety-three patent family members in forty-six 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:	193
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	5
Drug Prices:	Drug price information for mounjaro
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
First Affiliated Hospital of Wenzhou Medical University	PHASE2
Nicholas Skertich	EARLY_PHASE1
Vanderbilt University Medical Center	Phase 2

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 eight 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	215866-002	May 13, 2022		RX	Yes	Yes
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-011	Jul 28, 2023		RX	Yes	Yes
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-006	May 13, 2022		RX	Yes	Yes	9,474,780		Y	Y
Eli Lilly And Co	MOUNJARO (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-001	May 13, 2022		RX	Yes	Yes	12,295,987
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-010	Jul 28, 2023		RX	Yes	Yes	12,295,987
Eli Lilly And Co	MOUNJARO	tirzepatide	SOLUTION;SUBCUTANEOUS	215866-007	Jul 28, 2023		RX	Yes	Yes	12,295,987

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/005620Mounjaro 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

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Finland

France

Hungary

Israel

Japan

Jordan

Lithuania

Luxembourg

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
Slovenia	3826662
China	112608377	GIP和GLP-1共激动剂化合物 (GIP and GLP-1 co-agonist compounds)
Mexico	2012010120	DISPOSITIVO DE INYECCION AUTOMATICA CON MECANISMO DE RETARDO QUE INCLUYE MIEMBRO DE SESGADO DE FUNCIONAMIENTO DUAL. (AUTOMATIC INJECTION DEVICE WITH DELAY MECHANISM INCLUDING DUAL FUNCTIONING BIASING MEMBER.)
New Zealand	770042
Poland	3810201
Taiwan	201636362	GIP and GLP-1 co-agonist compounds

Supplementary Protection Certificates for mounjaro

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3242887	C202330010	Spain		PRODUCT NAME: TIRZEPATIDA Y SALES FARMACEUTICAMENTE ACEPTABLES DE LA MISMA; NATIONAL AUTHORISATION NUMBER: EU/1/22/1685; DATE OF AUTHORISATION: 20220915; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1685; DATE OF FIRST AUTHORISATION IN EEA: 20220915
3242887	PA2023504,C3242887	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
3242887	C03242887/01	Switzerland		PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022
3242887	LUC00296	Luxembourg		PRODUCT NAME: TIRZEPATIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887	301217	Netherlands		PRODUCT NAME: TIRZEPATIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/22/1685 20220919

Market Dynamics and Financial Trajectory for MOUNJARO (tirzepatide)

Last updated: December 2, 2025

Summary

MOUNJARO (tirzepatide), developed by Eli Lilly and Company, is a groundbreaking dual GIP/GLP-1 receptor agonist approved by the FDA in May 2022 for the treatment of type 2 diabetes mellitus (T2DM). Building on Lilly’s established dominance in the diabetes market with Trulicity, MOUNJARO has rapidly gained market share due to its superior efficacy and novel dual mechanism. This analysis explores the current market dynamics, regulatory landscape, sales trajectory, competitive positioning, and future financial expectations for MOUNJARO, projecting its potential influence on the diabetes therapeutics market over the next five years.

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What Are the Key Market Drivers for MOUNJARO?

Driver	Details	Impact
Efficacy Profile	Superior HbA1c reduction and weight loss vs. competitors like semaglutide (Ozempic/Semagluide)	Accelerates market adoption
Dual Mechanism of Action	Combines GIP and GLP-1 pathways	Differentiates from traditional GLP-1 receptor agonists
Regulatory Approvals	Approved in multiple regions (US, EU, Japan)	Broadening access and use cases
Cardiovascular Benefits	Demonstrated CV safety and potential reduction in CV events in trials	Increasing prescriber confidence
Market Need	Rising global prevalence of T2DM and obesity	Expanding patient pool

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How Has MOUNJARO’s Market Entry Reshaped the Diabetes Drug Landscape?

Regulatory Milestones and Approvals

Region	Date	Status	Notes
United States	May 13, 2022	FDA Approved	For T2DM, with potential expansion for obesity
European Union	May 2023	Approval granted	Fast-track due to unmet needs
Japan	July 2022	Approved	First dual GIP/GLP-1 receptor agonist in Japan

Market Penetration and Sales Data

Quarter	U.S. Sales (USD Millions)	Global Sales (USD Millions)	Notes
Q2 2022	N/A	$50	Launch phase
Q4 2022	$210	$350	Rapid uptake
Q2 2023	$750	$1,200	Expansion, new formulary listings

Source: Eli Lilly quarterly reports[1], market research firms[2].

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How Does MOUNJARO’s Sales Performance Compare to Competitors?

Drug	Mechanism	Market Share (Q2 2023)	Notable Strengths	Challenges
MOUNJARO	Dual GIP/GLP-1	35%	Superior glycemic control, weight loss	Price point, prescriber education
Ozempic (semaglutide)	GLP-1	28%	Established efficacy, broad formulary adoption	Slightly less weight reduction
Trulicity (dulaglutide)	GLP-1	20%	Long-acting, high patient adherence	Slightly lower efficacy

Note: MOUNJARO’s rapid growth is driven by its dosing flexibility and approval in obesity treatment, which is currently a booming segment.

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What Are the Financial Projections for MOUNJARO (2023-2028)?

Revenue Forecasts

Year	Estimated Global Sales (USD Millions)	Compound Annual Growth Rate (CAGR)	Assumptions
2023	$1.7 Billion	50%	Expansion into new markets and indications
2024	$3.4 Billion	100%	Heightened adoption based on ongoing CV outcome data
2025	$5.8 Billion	70%	Entry into additional indications (obesity)
2026	$8.9 Billion	53%	Increased global footprint, possible biosimilar entry
2027	$11.2 Billion	26%	Saturation in core markets, lifecycle management

Key Assumptions: Launch of obesity indication, formulary access expansion, and favorable clinical data.

Cost and Pricing Considerations

Pricing Tier	US Therapeutic Price	Global Price Range	Cost Factors
Brand-name	~$1,000/month	$700–$1,200/month	R&D recovery, comparator premiums
Potential Biosimilar Entry	Price erosion possible within 5 years	N/A	Market competition

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What Are the Competitive Challenges MOUNJARO Faces?

Pricing and Reimbursement

Challenge	Details	Implication
High Cost	Price premium over traditional GLP-1s	Payer resistance
Reimbursement Delays	Varies across regions	Limiting access

Market Saturation and Competition

Competitor	Key Strengths	Threats
Semaglutide (Ozempic, Wegovy)	Proven efficacy, weight-loss effects	Similar or superior efficacy, market perception
Tirzepatide (other formulations)	Potential more convenient delivery	Development delays

Regulatory and Safety Concerns

Aspect	Details	Outlook
Long-term Safety Data	Still accumulating	Key for sustained prescriber confidence
Cardiovascular Outcomes	Ongoing trials	May influence formulary decisions

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How Will Future Regulatory and Market Trends Impact MOUNJARO?

Expansion into Obesity and Other Indications

Timeline	Approval Possibilities	Significance
2024–2025	Obesity indication approval	Diversifies revenue streams
2025–2026	NASH, cardiovascular indications	Addresses unmet needs

Legislative and Policy Environment

Trend	Impact	Strategy
Value-based Pricing	Price negotiation pressures	Emphasize clinical outcomes
International Coverage	Market expansion	Local manufacturing, pricing strategies

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Comparison Table: MOUNJARO vs. Competitors

Attribute	MOUNJARO	Ozempic	Trulicity	Rybelsus (oral semaglutide)
Mechanism	Dual GIP/GLP-1	GLP-1	GLP-1	Oral GLP-1
Approved Indications	T2DM, Obesity (pending)	T2DM, Obesity	T2DM	T2DM
HbA1c Reduction	-1.5 to -2.0%	-1.3 to -1.8%	-1.2 to -1.8%	-1.0 to -1.5%
Weight Loss	12-15 kg	10-13 kg	8-10 kg	4-6 kg
Dosing Frequency	Weekly	Weekly	Weekly	Daily

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Key Market Insights and Strategic Implications

• MOUNJARO’s dual action provides a competitive advantage in glycemic control and weight reduction, leading to rapid market adoption.
• Pricing strategies will be pivotal as payers seek value, especially with increasing competition.
• Expansion into obesity indicates significant growth potential, with Wegovy (Semaglutide) being a primary competitor.
• Global market penetration will depend on regulatory approvals and local pricing policies.
• Clinical trials on long-term safety and CV outcomes will influence prescriber confidence and payer reimbursement decisions.

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FAQs

1. What makes MOUNJARO different from other GLP-1 receptor agonists?
MOUNJARO combines GIP and GLP-1 receptor agonism, yielding superior reductions in HbA1c and weight loss compared to traditional GLP-1 therapies like semaglutide and dulaglutide, which target only GLP-1 pathways.

2. What are the main regulatory hurdles for MOUNJARO’s expansion into new indications?
While FDA approvals are secured for T2DM, expanding into obesity and other indications requires additional clinical trial data demonstrating safety and efficacy, especially for long-term outcomes.

3. How does MOUNJARO’s pricing compare to competitors?
Pricing is approximately $1,000/month in the US, positioning it at a premium compared to older GLP-1 agents, but competitive given its clinical benefits. Price negotiations and biosimilar development could impact future costs.

4. What is the forecast for MOUNJARO’s global market share?
Market share is projected to grow rapidly, potentially reaching 35-50% of the injectable T2DM market within five years, driven by clinical efficacy and expanding indications.

5. How might biosimilars impact MOUNJARO’s revenue?
Biosimilar competition is expected within 5-7 years post-launch, potentially eroding prices and margins; however, MOUNJARO’s clinical advantages could delay market entry of biosimilars.

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Key Takeaways

• Innovation and Efficacy: MOUNJARO’s dual GIP/GLP-1 receptor activation distinguishes it, underpinning strong early sales and market adoption.
• Market Growth: With projected global sales surpassing $11 billion by 2027, MOUNJARO is positioning itself as a dominant player in T2DM and obesity markets.
• Competitive Landscape: Rapid adoption faces pressure from semaglutide-based therapies and potential biosimilars; differentiation through clinical outcomes remains critical.
• Regulatory and Policy Environment: Broader approvals and favorable reimbursement will be pivotal for sustained growth.
• Strategic Focus: Continued clinical validation, global expansion, and diversification into new indications are key to maximizing MOUNJARO’s financial trajectory.

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References

[1] Eli Lilly Quarterly Financial Reports, 2022-2023.
[2] Market Research Reports: Diabetes Pharmacotherapy Market, 2023.
[3] FDA & EMA approval documents for MOUNJARO.
[4] Clinical trial registries for tirzepatide CV and weight-loss data.