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. Fifteen 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:	1
Clinical Trials:	136
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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	PHASE2
Zenith Epigenetics	PHASE2
National Cancer Institute (NCI)	PHASE2

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	019732-001	Jan 26, 1989
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	019732-001	Jan 26, 1989
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-001	Dec 22, 1995
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-002	May 30, 1997
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020011-001	Oct 22, 1990
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	019732-001	Jan 26, 1989

International Patents for LUPRON DEPOT

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

Country	Patent Number	Title	Estimated Expiration
Canada	2671670	COMPOSITION A LIBERATION PROLONGEE ET PROCEDE DE PRODUCTION CORRESPONDANT (SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME)
Canada	2455392	COMPOSITION A LIBERATION CONTROLEE COMPRENANT UN POLYMERE D'ACIDE LACTIQUE ET DE L'ACIDE HYDROXYNAPHTALENECARBOXYLIQUE ET METHODE POUR LA PRODUIRE (CONTROLLED RELEASE COMPOSITION COMPRISING LACTIC ACID POLYMER AND HYDROXYNAPHTHOIC ACID, AND METHOD OF PRODUCING THE SAME)
World Intellectual Property Organization (WIPO)	2008075762
Czech Republic	306327	Kompozice s regulovaným uvolňováním a způsob její výroby (Controlled release composition and process for preparing thereof)
Japan	5258844
South Africa	200903644

Market Dynamics and Financial Trajectory for Lupron Depot

Last updated: July 27, 2025

Introduction

Lupron Depot, a prodrug of leuprolide acetate, serves as a flagship treatment for hormone-dependent cancers and conditions such as prostate cancer, endometriosis, and uterine fibroids. Its market presence is driven by evolving clinical practices, patent landscapes, regulatory decisions, and competitive dynamics within the pharmaceutical industry. Understanding these factors is vital for stakeholders aiming to navigate its commercial and R&D trajectory effectively.

Market Overview

Lupron Depot is produced by AbbVie (formerly part of Abbott Laboratories), leveraging its extended-release formulation that enables monthly or quarterly dosing, significantly enhancing patient compliance. The drug's mechanism involves sustained suppression of gonadotropins to manage hormone-sensitive conditions, making it a critical therapeutic option globally.

The global prostate cancer treatment market alone was valued at approximately USD 10 billion in 2021, with a significant segment dedicated to hormone therapy—including Lupron Depot. The market for endometriosis and uterine fibroids treatments was similarly substantial, collectively supporting a robust demand pipeline.

Market Drivers

1. Increasing Prevalence of Target Diseases

The rising incidence of prostate cancer, particularly among aging males, fuels demand. The American Cancer Society estimates over 248,000 new prostate cancer cases in the United States annually. Similarly, endometriosis affects up to 10% of reproductive-aged women, creating consistent demand for hormonal therapies like Lupron Depot.

2. Therapeutic Adoption and Clinical Guidelines

Clinical guidelines increasingly favor GnRH analogs for hormone suppression, especially in early prostate cancer management and symptomatic endometriosis. The convenience of Lupron Depot's extended-release formulations enhances its adoption, further bolstered by physician familiarity and established efficacy.

3. Patent Lifecycle and Formulation Innovations

Lupron Depot's original patents expired in key markets around 2018–2020, paving the way for biosimilars and generic formulations. However, AbbVie's strategic patent extensions and formulation patents have delayed generic penetration, preserving revenue streams.

4. Regulatory Environment

Regulatory agencies such as the FDA and EMA continually evaluate hormonal therapies, with approval processes favoring well-established drugs like Lupron Depot. The recent approval of new maintenance formulations and combination therapies can expand indications and patient populations.

5. Competitive Landscape

While generic competition looms, proprietary formulations and delivery devices create barriers. The emergence of biosimilars like generic leuprolide injections could challenge market share but are often delayed by patent protections and regulatory hurdles.

Market Challenges

1. Patent Expirations and Biosimilar Threats

Patent expirations in 2018–2020 opened markets for biosimilar leuprolide formulations. While initial market penetration was limited due to manufacturing, pricing, and preference issues, evolving biosimilar options may pressure Lupron Depot’s pricing and margins.

2. Pricing and Reimbursement Policies

Reimbursement policies, particularly in cost-sensitive healthcare systems, influence sales. Price reductions driven by payer negotiations and cost-effectiveness evaluations can impact revenue growth.

3. Competition from Alternative Therapies

Non-hormonal treatments, targeted therapies, and advanced surgical options could reduce reliance on hormone suppression, especially if new therapies demonstrate superior efficacy or safety profiles.

4. Market Saturation in Mature Regions

In developed markets, the penetration of Lupron Depot approaches saturation, with incremental growth reliant on expanding indications or new formulation launches.

Financial Trajectory and Outlook

1. Revenue Trends

Historically, Lupron Depot has been a significant revenue contributor for AbbVie, generating approximately USD 1.2 billion annually pre-generic competition. Post-patent expiry, revenue declines are expected, aligning with biosimilar market entry and generic competition.

2. Impact of Biosimilars

As biosimilars gain approval in regions like the EU and US, pricing pressures are poised to reduce average selling prices. AbbVie's strategy involves leveraging formulation patents, maintaining exclusive pricing for as long as possible, and expanding indications.

3. Pipeline Developments and Line Extensions

AbbVie continues to develop new formulations, including depot formulations with longer dosing intervals, aiming to extend the product lifecycle. Additionally, combination mechanisms, such as GnRH antagonists and hormone receptor modulators, could open new revenue streams.

4. Forecasted Market Share

In the short to medium term, branded Lupron Depot could lose share to biosimilars but might offset declines via expanding indications (e.g., prostate cancer neoadjuvant therapy, breast cancer palliation), special formulations, and geographic expansion.

5. Strategic Growth Opportunities

Emerging markets represent a substantial growth opportunity due to increasing healthcare infrastructure and rising disease prevalence. Moreover, novel delivery systems and personalized medicine approaches could sustain or elevate its financial trajectory.

Regulatory and Clinical Innovation Impact

Regulatory agencies favor drugs with proven efficacy and safety, especially for chronic conditions. AbbVie's strategic approvals, including potential indications in castration-resistant prostate cancer and adverse event management, bolster their market position. Clinical trials focused on combo therapies or novel formulations could influence future demand.

Conclusion

Lupron Depot's market dynamics are shaped by a confluence of patent landscapes, biosimilar competition, clinical guidelines, and emerging therapeutic alternatives. While facing revenue compression due to patent expirations, ongoing innovation, geographic expansion, and indication broadening present pathways for stabilization and growth. The financial trajectory hinges on strategic patent management, regulatory approvals, and market adaptation.

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Key Takeaways

• The expiration of key patents significantly impacted Lupron Depot’s revenue, with biosimilar entry expected to exert downward pricing pressure.
• The drug maintains pivotal roles in prostate cancer, endometriosis, and uterine fibroids treatments, underpinning sustained demand.
• AbbVie’s strategic patent protections, formulation innovations, and geographic expansion are vital to its long-term financial outlook.
• Biosimilar competition remains the primary market challenge, prompting innovation in formulation and indication expansion.
• Emerging markets and combination therapies offer notable growth opportunities, potentially offsetting patent-related declines.

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FAQs

1. How have patent expirations affected Lupron Depot's market share?
Patent expirations around 2018–2020 led to the emergence of biosimilars and generics, decreasing branded sales and market share in regions like the US and EU. While initial biosimilar penetration was slow, ongoing competition is expected to further compress revenue margins.

2. What strategies is AbbVie employing to maintain Lupron Depot’s market viability?
AbbVie leverages formulation patents, develops new formulations with extended dosing intervals, expands internationally, and explores additional indications to extend product lifecycle and maintain competitive advantage.

3. How significant is biosimilar competition for Lupron Depot?
Biosimilar leuprolide formulations pose a notable threat, with approvals in major markets potentially reducing prices and revenue. The extent of impact depends on biosimilar market penetration and reimbursement policies.

4. Which geographic regions offer the most growth potential for Lupron Depot?
Emerging markets in Asia, Latin America, and parts of the Middle East present substantial growth opportunities due to rising disease prevalence and improving healthcare infrastructure.

5. What future clinical developments could influence Lupron Depot’s market?
New formulations with longer intervals, combination therapies for resistant conditions, and expanding indications in oncology and gynecology could enhance future market prospects.

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References

1. American Cancer Society. "Cancer Facts & Figures 2022."
2. MarketWatch. "Prostate Cancer Treatment Market Size, Share & Trends Analysis."
3. AbbVie Annual Report 2021.
4. U.S. FDA Drugs Approved in 2022.
5. GlobalData. "Biosimilar Leuprolide Market Outlook."