LUPRON DEPOT Drug Patent Profile

When do Lupron Depot patents expire, and when can generic versions of Lupron Depot launch?

Lupron Depot is a drug marketed by Abbvie Endocrine Inc and is included in five NDAs. There are two patents protecting this drug.

This drug has thirty-five patent family members in twenty-eight countries.

The generic ingredient in LUPRON DEPOT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lupron Depot

A generic version of LUPRON DEPOT was approved as leuprolide acetate by SANDOZ on August 4^th, 1998.

Summary for LUPRON DEPOT

International Patents:	35
US Patents:	2
Applicants:	1
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	134
Drug Prices:	Drug price information for LUPRON DEPOT
What excipients (inactive ingredients) are in LUPRON DEPOT?	LUPRON DEPOT excipients list
DailyMed Link:	LUPRON DEPOT at DailyMed

See drug prices for LUPRON DEPOT

Recent Clinical Trials for LUPRON DEPOT

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

Sponsor	Phase
NRG Oncology	Phase 2
Panbela Therapeutics	Phase 2
Prostate Cancer Foundation	Phase 2

See all LUPRON DEPOT clinical trials

US Patents and Regulatory Information for LUPRON DEPOT

LUPRON DEPOT is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020011-001	Oct 22, 1990		DISCN	Yes	No
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-003	Jun 17, 2011		RX	Yes	Yes			Y
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020708-001	Mar 7, 1997		RX	Yes	Yes
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994		RX	Yes	Yes
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-003	Jun 17, 2011		RX	Yes	Yes

Expired US Patents for LUPRON DEPOT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-002	May 30, 1997
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020708-001	Mar 7, 1997
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	019732-001	Jan 26, 1989
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020708-001	Mar 7, 1997
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020708-001	Mar 7, 1997
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-001	Dec 22, 1995

International Patents for LUPRON DEPOT

See the table below for patents covering LUPRON DEPOT around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1111708
European Patent Office	0586238	Procédé de préparation de microcapsules à libération prolongée (Method of producing sustained-release microcapsules)
World Intellectual Property Organization (WIPO)	03002092
Eurasian Patent Organization	016176	КОМПОЗИЦИЯ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ И СПОСОБ ЕЁ ПОЛУЧЕНИЯ (SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME)
Brazil	0210561
China	1055618

LUPRON DEPOT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LUPRON DEPOT (Leuprolide Acetate)

Market Overview

LUPRON DEPOT, a formulation of leuprolide acetate, is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). This drug is widely used for treating conditions such as prostate cancer, endometriosis, and uterine fibroids.

Market Size and Growth

The global leuprolide acetate market, which includes LUPRON DEPOT, is projected to experience significant growth. As of 2024, the market is valued at approximately USD 3.82 billion and is expected to reach USD 5.81 billion by 2031, exhibiting a compound annual growth rate (CAGR) of 6.2% during this period[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Prostate Cancer and Endometriosis

The rising incidence of prostate cancer and endometriosis globally is a major driver of the leuprolide acetate market. Prostate cancer is one of the most common cancers affecting men worldwide, and leuprolide acetate is an effective treatment for these conditions. This increasing demand, particularly in regions with growing healthcare needs like North America and the Asia Pacific, fuels market growth[1].

Advanced Drug Delivery Formulations

The development of advanced drug delivery formulations, such as pre-filled syringes, enhances the efficacy and reduces the treatment duration of leuprolide acetate. For instance, the introduction of LUPRON DEPOT in pre-filled dual-chamber syringes has been well-received due to its convenience and reduced patient risk[4].

Regional Market Dynamics

North America

North America currently dominates the global leuprolide acetate market, with an estimated market share of 40.3% in 2024. This dominance is attributed to the strong healthcare infrastructure and the presence of many key market players in the U.S. and Canada. The region's robust distribution channel and supply chain also contribute to its leadership position[1].

Asia Pacific

The Asia Pacific region is emerging as the fastest-growing market for leuprolide acetate. Countries like China and India, with their large population bases and improving healthcare indices, are driving this growth. The expanding pharmaceutical industry in these regions, coupled with lower manufacturing and labor costs, further accelerates market expansion[1].

Market Challenges

High Costs Associated with R&D Investments

The development of new drug formulations, including those of leuprolide acetate, is highly capital-intensive. Extensive research and clinical trials are necessary to ensure safety and efficacy, which can result in significant financial losses if the trials fail. Additionally, stringent regulatory requirements for drug approval add to the costs and complexity of bringing new drugs to market[1].

Price Erosion and Generic Versions

The advent of generic versions of leuprolide acetate can lead to price erosion, particularly once leading brand drugs lose their patents. This can hamper the revenue growth of market leaders. However, market players can mitigate this by engaging in licensing deals to manufacture and sell generic versions in emerging markets[1].

Regulatory Hurdles

Stringent regulatory requirements for drug approval can slow down the entry of new players into the market. Companies must navigate complex and costly approval processes, which can be a significant barrier to market entry[1].

Market Opportunities

Strategic Collaborations

Market players can capitalize on strategic collaborations with local pharmaceutical companies to minimize regulatory and market entry barriers. Licensing deals to manufacture and sell generic versions in emerging markets can provide significant opportunities for growth[1].

Emerging Markets

Focusing on emerging markets through local partnerships is a prudent strategy. Countries in the Asia Pacific region, such as China and India, offer substantial growth potential due to their large patient populations and improving healthcare infrastructure[1].

Financial Performance

Revenue and Profitability

The financial performance of companies involved in the leuprolide acetate market can be volatile due to various factors such as R&D expenses, regulatory approvals, and market competition. For example, Sumitomo Pharma's financial reports show fluctuations in revenue and profitability, with significant investments in R&D and varying impacts from forex situations and licensing agreements[2].

Cost Structure

The cost structure for leuprolide acetate includes high R&D expenses, significant SG&A (Selling, General, and Administrative) expenses, and costs associated with clinical trials and regulatory approvals. These costs can impact the profitability of market players, making it essential to manage expenses strategically[2].

Product Forms and Distribution

Pre-filled Syringes

The pre-filled syringes segment of the leuprolide acetate market was valued at over USD 910 million in 2022. This format is gaining popularity due to its convenience, reduced patient risk, and lower time and money investment. The introduction of LUPRON DEPOT in pre-filled dual-chamber syringes has been particularly successful, with less than 5% of patient reactions reported[4].

Clinical Efficacy and Safety

Treatment Outcomes

LUPRON DEPOT has demonstrated significant clinical efficacy in treating conditions such as uterine fibroids and endometriosis. For instance, clinical trials have shown that LUPRON DEPOT can decrease uterine and fibroid volume, reduce symptoms like pelvic pain and excessive vaginal bleeding, and improve hematologic parameters[3].

Safety Profile

The safety profile of LUPRON DEPOT includes potential side effects such as bone loss and changes in laboratory values. However, these effects are generally manageable with appropriate monitoring and treatment adjustments. For example, regular laboratory monitoring has shown that AST levels and other liver enzymes can be elevated in some patients, but these are typically not associated with clinical or other laboratory evidence of abnormal liver function[3].

Key Takeaways

• The global leuprolide acetate market, including LUPRON DEPOT, is expected to grow significantly, driven by increasing prevalence of prostate cancer and endometriosis.
• Advanced drug delivery formulations, such as pre-filled syringes, are enhancing market growth.
• North America dominates the market, but the Asia Pacific region is emerging as the fastest-growing segment.
• High R&D costs, price erosion from generic versions, and stringent regulatory requirements are key challenges.
• Strategic collaborations and focus on emerging markets offer significant opportunities for growth.

FAQs

Q: What is the projected market size of leuprolide acetate by 2031?

The global leuprolide acetate market is expected to reach USD 5.81 billion by 2031[1].

Q: What are the main drivers of the leuprolide acetate market growth?

The main drivers include the increasing prevalence of prostate cancer and endometriosis, and the development of advanced drug delivery formulations[1][4].

Q: Which region is currently dominating the leuprolide acetate market?

North America currently dominates the market, with an estimated market share of 40.3% in 2024[1].

Q: What are the significant challenges faced by the leuprolide acetate market?

High costs associated with R&D investments, price erosion from generic versions, and stringent regulatory requirements are significant challenges[1].

Q: How does LUPRON DEPOT impact the treatment of uterine fibroids?

LUPRON DEPOT has been shown to decrease uterine and fibroid volume, reduce symptoms like pelvic pain and excessive vaginal bleeding, and improve hematologic parameters[3].

Sources

1. Coherent Market Insights: Leuprolide Acetate Market - Report & Production Statistics
2. Sumitomo Pharma: Investors Meeting Presentation for FY2022
3. FDA: Lupron Depot (leuprolide acetate) injection
4. Global Market Insights: Leuprolide Acetate Market Share | Forecasts Report, 2023-2032