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zepbound Drug Patent Profile

When do Zepbound patents expire, and what generic alternatives are available?

Zepbound is a drug marketed by Eli Lilly And Co and is included in one NDA. There are three patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Zepbound

Zepbound 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 zepbound

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

See drug prices for zepbound

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

NDA:

217806

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 zepbound

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 2

See all zepbound clinical trials

Pharmacology for zepbound

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 zepbound

zepbound is protected by three US patents and two FDA Regulatory Exclusivities.

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	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-002	Nov 8, 2023		RX	Yes	Yes
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-001	Nov 8, 2023		RX	Yes	Yes			Y	Y
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-004	Nov 8, 2023		RX	Yes	Yes
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-005	Nov 8, 2023		RX	Yes	Yes
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-003	Nov 8, 2023		RX	Yes	Yes			Y	Y
Eli Lilly And Co	ZEPBOUND (AUTOINJECTOR)	tirzepatide	SOLUTION;SUBCUTANEOUS	217806-004	Nov 8, 2023		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for zepbound

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 zepbound

When does loss-of-exclusivity occur for zepbound?

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 zepbound around the world.

Country	Patent Number	Title	Estimated Expiration
Chile	2020003359	Composiciones agonistas de gip/glp1
Japan	2018052933	ＧＩＰおよびＧＬＰ−１コアゴニスト化合物 (GIP AND GLP-1 CO-AGONIST COMPOUNDS)
Hungary	E063059
France	23C1006
Lithuania	3810201
Poland	3810201

Supplementary Protection Certificates for zepbound

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3242887	PA2023504	Lithuania		PRODUCT NAME: TIRZEPATIDAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1685 20220915
3242887	2023C/506	Belgium		PRODUCT NAME: TIRZEPATIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1685 20220919
3242887	122023000012	Germany		PRODUCT NAME: TIRZEPATIDE UND PHARMAZEUTISCH AKZEPTABLE SALZE DAVON; REGISTRATION NO/DATE: EU/1/22/1685 20220915
3242887	301217	Netherlands		PRODUCT NAME: TIRZEPATIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/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	C03242887/01	Switzerland		PRODUCT NAME: TIRZEPATID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68726 02.11.2022

Zepbound Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zepbound

Introduction

Zepbound, Eli Lilly's latest glucagon-like peptide 1 (GLP-1) agonist, has been making significant waves in the pharmaceutical industry since its FDA approval in November 2023. Here, we delve into the market dynamics and financial trajectory of this weight-loss drug, highlighting its impact, competition, and future projections.

FDA Approval and Market Entry

Zepbound's approval marked Eli Lilly's entry into the weight-loss drug market, directly competing with Novo Nordisk's Wegovy, which had been the market leader since its approval in June 2021. This move has intensified the competition in the GLP-1 agonist space, particularly for weight loss treatments[1][4].

Sales Performance

Since its approval, Zepbound has shown remarkable sales growth. In the second quarter of 2024, Zepbound generated $1.24 billion in sales, significantly exceeding analyst expectations of $922.2 million. This performance is particularly impressive given that it is only the second full quarter of sales for the drug. The first quarter of 2024 saw Zepbound sales of $517 million, already surpassing initial projections[1][5].

Market Share and Competition

As of the second quarter of 2024, Eli Lilly has captured around 40% of the U.S. weight-loss drug market with Zepbound. Analysts predict that by the end of 2024, the market share could be split roughly 50-50 between Zepbound and Wegovy, assuming supply constraints for Novo Nordisk's products continue. However, if supply issues ease, Zepbound could gain an edge due to its greater weight loss efficacy and improving supply chain[1].

Supply Chain and Manufacturing

Eli Lilly has been investing heavily in expanding its manufacturing capabilities to meet the growing demand for Zepbound. A significant $5.3 billion investment in its Indiana site aims to increase production of the active pharmaceutical ingredients for tirzepatide, the molecule behind both Zepbound and Mounjaro. This investment is expected to alleviate supply constraints and support the drug's continued growth[1][3].

Prescription Trends

New U.S. prescriptions for Zepbound have been on the rise, with the drug surpassing Wegovy in new prescriptions for the first time in early March 2024. This trend indicates strong market acceptance and growing physician confidence in Zepbound's efficacy[1].

Efficacy and Clinical Outcomes

Zepbound has demonstrated greater weight loss compared to Wegovy in clinical studies. An observational study published recently highlighted the superior weight loss outcomes associated with Zepbound, further bolstering its market position[1].

Financial Projections

Analysts are optimistic about Zepbound's future sales. For 2024, Zepbound sales are projected to range between $2.2 billion and $2.7 billion, according to forecasts from Morgan Stanley and Bank of America. By 2030, Zepbound is predicted to generate $27.2 billion in sales, outpacing Wegovy's projected $18.7 billion. Some analysts even suggest that Zepbound could become the best-selling drug of all time, potentially overtaking Humira (adalimumab)[1][2].

Impact on Eli Lilly's Financials

The success of Zepbound, along with Mounjaro, has significantly boosted Eli Lilly's financial performance. The company's revenue for the second quarter of 2024 climbed 36% to $11.3 billion, with adjusted earnings totaling $3.92 per share, well above analyst expectations. Eli Lilly has raised its full-year revenue forecast by $3 billion and expects to generate an additional $7 billion in revenue in 2025 above previous consensus estimates[1][5].

Market Access and Insurance Coverage

Despite its strong performance, Zepbound faces market access and supply challenges. Insurance coverage is improving, but there are concerns about the drug's high cost and its potential impact on commercial plan premiums. However, as coverage expands, Zepbound is likely to become more accessible to a broader patient population[4][5].

Stock Performance

Eli Lilly's stock has seen significant growth, driven by the success of Zepbound and Mounjaro. The company's stock price has climbed 119% over the past year, reaching new all-time highs. Analysts predict continued growth, with some models suggesting the stock could surpass $1,000 per share by the end of 2024[2][3].

Broader Market Impact

The success of Zepbound is part of a larger trend in the anti-obesity drug market, which is expected to grow significantly. Goldman Sachs projects that the broader market for anti-obesity drugs could hit $100 billion per year by 2030, a 16-fold increase from 2023 levels. This growth underscores the increasing demand for effective weight loss treatments and positions Zepbound as a key player in this expanding market[2].

Conclusion

Zepbound's entry into the weight-loss drug market has marked a significant shift in the competitive landscape. With its strong sales performance, superior efficacy, and improving supply chain, Zepbound is poised to continue its upward trajectory. As the market evolves, it is clear that Zepbound will be a major revenue generator for Eli Lilly and a dominant force in the weight-loss drug market.

Key Takeaways

• Strong Sales Performance: Zepbound has exceeded analyst expectations with $1.24 billion in Q2 2024 sales.
• Market Share: Eli Lilly has captured around 40% of the U.S. weight-loss drug market with Zepbound.
• Supply Chain Investments: Significant investments in manufacturing to alleviate supply constraints.
• Efficacy: Zepbound has shown greater weight loss compared to Wegovy.
• Financial Projections: Projected sales of $27.2 billion by 2030.
• Market Access: Improving insurance coverage but potential impact on commercial plan premiums.

FAQs

Q: What is Zepbound, and when was it approved by the FDA? A: Zepbound is a glucagon-like peptide 1 (GLP-1) agonist approved by the FDA in November 2023 for weight loss.

Q: How has Zepbound performed in terms of sales since its approval? A: Zepbound generated $1.24 billion in sales in Q2 2024, exceeding analyst expectations, and $517 million in Q1 2024.

Q: What is the current market share of Zepbound in the U.S. weight-loss drug market? A: Zepbound has captured around 40% of the U.S. weight-loss drug market.

Q: How does Zepbound compare to Novo Nordisk's Wegovy in terms of efficacy? A: Zepbound has shown greater weight loss compared to Wegovy in clinical studies.

Q: What are the projected sales for Zepbound by 2030? A: Zepbound is predicted to generate $27.2 billion in sales by 2030.

Sources

1. Biospace: "Watch Out Novo, Lilly Is Closing the Gap in the Weight-Loss Drug Race"
2. Drug Discovery Trends: "Eli Lilly's Mounjaro sales projected to triple in 2024"
3. Investing.com: "Eli Lilly's SWOT analysis: stock soars on obesity drug success"
4. MMIT Network: "Zepbound Faces Market Access, Supply Challenges"
5. WTOP: "Mounjaro, Zepbound pour money into Eli Lilly, fueling a better-than-expected second-quarter"