ZEPBOUND (AUTOINJECTOR) Drug Patent Profile

Which patents cover Zepbound (autoinjector), and when can generic versions of Zepbound (autoinjector) launch?

Zepbound (autoinjector) 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 (AUTOINJECTOR) is tirzepatide. One supplier is listed for this compound. Additional details are available on the tirzepatide profile page.

DrugPatentWatch^® Generic Entry Outlook for Zepbound (autoinjector)

Zepbound (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 ZEPBOUND (AUTOINJECTOR)

International Patents:	111
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	ZEPBOUND (AUTOINJECTOR) at DailyMed

Pharmacology for ZEPBOUND (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 ZEPBOUND (AUTOINJECTOR)

ZEPBOUND (AUTOINJECTOR) is protected by three US patents and three FDA Regulatory Exclusivities.

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	217806-006	Nov 8, 2023		RX	Yes	Yes			Y	Y
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	217806-006	Nov 8, 2023		RX	Yes	Yes			Y

EU/EMA Drug Approvals for ZEPBOUND (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 ZEPBOUND (AUTOINJECTOR)

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

Country	Patent Number	Title	Estimated Expiration
Australia	2016205435	GIP and GLP-1 co-agonist compounds
Eurasian Patent Organization	023084	ЗАМЕДЛИТЕЛЬ ДЛЯ АВТОМАТИЧЕСКОГО ИНЪЕКЦИОННОГО УСТРОЙСТВА, ВКЛЮЧАЮЩИЙ СМЕЩАЮЩИЙ ЭЛЕМЕНТ С ДВОЙСТВЕННОЙ ФУНКЦИЕЙ (AUTOMATIC INJECTION DEVICE WITH DELAY MECHANISM INCLUDING DUAL FUNCTIONING BIASING MEMBER)
European Patent Office	3810201	COMPOSITIONS AGONISTES GIP/GLP1 (GIP/GLP1 AGONIST COMPOSITIONS)

Supplementary Protection Certificates for ZEPBOUND (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

ZEPBOUND (AUTOINJECTOR) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zepbound (Autoinjector)

Introduction

Zepbound, a weight loss medication developed by Eli Lilly, has been making significant waves in the pharmaceutical market. This drug, which contains the active ingredient tirzepatide, is part of a broader class of GLP-1 receptor agonists that have revolutionized the treatment of obesity and related conditions.

Market Growth and Demand

The demand for Zepbound has been robust, driven by its efficacy in reducing weight and improving metabolic health. The drug's popularity has led to widespread adoption, with Eli Lilly reporting exceptional growth trends since its launch. As of Q2 2024, Zepbound's U.S. branded anti-obesity prescriptions and new prescriptions have reached approximately 36% market share[3].

Supply Chain and Availability

Initially, Zepbound faced supply chain challenges, leading to shortages that affected patient access. However, Eli Lilly has since ramped up manufacturing capacity, and the introduction of single-dose vials has helped alleviate these issues. The vials, available through LillyDirect, have expanded the supply and access for patients, particularly those without comprehensive insurance coverage[4][5].

Pricing Strategy

The pricing of Zepbound has been a critical factor in its market dynamics. The autoinjector pen formulation was initially priced at around $1,000 per month before insurance, making it inaccessible to many. However, the introduction of single-dose vials at a lower price point ($399 for a 2.5 mg dose and $549 for a 5 mg dose per month) has made the drug more affordable for self-pay patients. This move not only addresses affordability concerns but also counters competition from compounded versions of tirzepatide offered by telehealth companies[4][5].

Competitive Landscape

Zepbound competes directly with Novo Nordisk's Wegovy, another GLP-1 receptor agonist used for weight loss. Both drugs work by stimulating GLP-1 receptors to reduce appetite and slow stomach emptying. The competition between these two drugs has driven innovation and pricing strategies, with both companies aiming to capture a larger share of the growing obesity treatment market[4].

Regulatory and Reimbursement Environment

The regulatory environment has been favorable for Zepbound. The drug has received necessary approvals, and its inclusion in commercial formularies has been rapid, with approximately 86% access as of July 2024. However, the lack of comprehensive insurance coverage for obesity medications remains a challenge, highlighting the need for policymakers, employers, and insurers to support equitable access to these treatments[3][5].

Technological Advancements

The use of autoinjectors for Zepbound has been enhanced by technological advancements. Autoinjectors with smart connectivity features, such as Bluetooth data tracking and dosage reminders, have improved patient compliance and disease management. These advancements are part of a broader trend in the autoinjector market, which is expected to grow significantly due to the increasing adoption of biologics and the need for home-based care[1].

Financial Performance

Eli Lilly's financial performance has been significantly boosted by the success of Zepbound. In Q2 2024, the company reported a 36% revenue growth driven by Zepbound, along with other new products like Mounjaro and Verzenio. The revenue growth from Zepbound is expected to continue, with the drug playing a crucial role in Lilly's portfolio expansion and market dominance[3].

Future Outlook

The future outlook for Zepbound is promising. With the resolution of supply chain issues and the introduction of more affordable formulations, the drug is poised to capture a larger market share. The ongoing investment in research and development, particularly in expanding the therapeutic indications for tirzepatide, will further drive growth. For instance, Eli Lilly has submitted tirzepatide for the treatment of moderate-to-severe obstructive sleep apnea and obesity, and has announced positive topline results from the SUMMIT Phase 3 trial in heart failure with preserved ejection fraction and obesity[3].

Key Takeaways

• Robust Demand: Zepbound has seen high demand due to its efficacy in weight loss and metabolic health improvement.
• Supply Chain Improvements: The introduction of single-dose vials has helped address supply chain issues and expand patient access.
• Pricing Strategy: Lower-priced vials have made the drug more affordable, countering competition from compounded versions.
• Favorable Regulatory Environment: Rapid inclusion in commercial formularies and regulatory approvals have supported market growth.
• Technological Advancements: Smart autoinjectors have enhanced patient compliance and disease management.
• Strong Financial Performance: Zepbound has significantly contributed to Eli Lilly's revenue growth.

FAQs

Q: What is Zepbound, and how does it work? A: Zepbound is a weight loss medication containing tirzepatide, a GLP-1 receptor agonist that reduces appetite and slows stomach emptying.

Q: Why did Zepbound face supply chain issues? A: Zepbound faced supply chain issues due to high demand and manufacturing capacity constraints, which have since been addressed with the introduction of single-dose vials.

Q: How has the pricing of Zepbound evolved? A: Initially priced at around $1,000 per month for the autoinjector pen, Zepbound is now available in single-dose vials at a lower price point ($399 for 2.5 mg and $549 for 5 mg per month).

Q: What are the competitive dynamics for Zepbound? A: Zepbound competes with Novo Nordisk's Wegovy, another GLP-1 receptor agonist used for weight loss.

Q: What role do technological advancements play in the use of Zepbound? A: Technological advancements, such as smart autoinjectors with Bluetooth connectivity, have improved patient compliance and disease management.

Sources

1. MarketsandMarkets: Autoinjectors Market Growth, Drivers, and Opportunities
2. NBC New York: Ro to offer lower-price vials of weight loss drug Zepbound by teaming up with Eli Lilly
3. Eli Lilly Investor Relations: Q2 2024 Lilly Presentation
4. BioPharma Dive: Lilly rolls out Zepbound vials at a discount price
5. PR Newswire: Lilly releases Zepbound® (tirzepatide) single-dose vials, expanding supply and access for adults living with obesity