LEUPROLIDE ACETATE FOR DEPOT SUSPENSION Drug Patent Profile

Which patents cover Leuprolide Acetate For Depot Suspension, and when can generic versions of Leuprolide Acetate For Depot Suspension launch?

Leuprolide Acetate For Depot Suspension is a drug marketed by Invagen Pharms and is included in one NDA.

The generic ingredient in LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 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 Leuprolide Acetate For Depot Suspension

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

Summary for LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	7
DailyMed Link:	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION at DailyMed

Recent Clinical Trials for LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

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

Sponsor	Phase
HanAll BioPharma Co., Ltd.	PHASE4
Myovant Sciences GmbH	Phase 3
Tolmar Inc.	Phase 3

See all LEUPROLIDE ACETATE FOR DEPOT SUSPENSION clinical trials

US Patents and Regulatory Information for LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Invagen Pharms	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	leuprolide acetate	FOR SUSPENSION;INTRAMUSCULAR	205054-001	Aug 28, 2018		RX	Yes	Yes

Expired US Patents for LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Invagen Pharms	LEUPROLIDE ACETATE FOR DEPOT SUSPENSION	leuprolide acetate	FOR SUSPENSION;INTRAMUSCULAR	205054-001	Aug 28, 2018

International Patents for LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

See the table below for patents covering LEUPROLIDE ACETATE FOR DEPOT SUSPENSION around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2362769	MICROCAPSULES POUR LA LIBERATION PROLONGEE DE MEDICAMENTS (MICROCAPSULES FOR SUSTAINED RELEASE OF DRUGS)
Australia	2173501
Australia	774680
Spain	2169980	MICROCAPSULAS PARA LA LIBERACION PROLONGADA DE FARMACOS.
Japan	2003516960
Austria	234608

Market Dynamics and Financial Trajectory for Leuprolide Acetate for Depot Suspension

Last updated: August 9, 2025

Introduction

Leuprolide acetate for depot suspension, a gonadotropin-releasing hormone (GnRH) analog used primarily in hormone-sensitive cancers and chronic conditions such as prostate cancer, breast cancer, endometriosis, and central precocious puberty, remains a strategically significant segment within the pharmaceutical landscape. The drug's unique formulation offers extended-release benefits, reducing dosing frequency, improving patient compliance, and enhancing therapeutic outcomes. This report examines the evolving market dynamics and projected financial trajectory for leuprolide acetate for depot suspension, considering current trends, competitive environment, regulatory factors, and emerging opportunities.

Market Overview

Leuprolide acetate's role as a cornerstone in hormone therapy has cemented its position within the global oncology and endocrinology sectors. The depot suspension formulation, allowing sustained drug release over intervals ranging from one to three months, aligns with the burgeoning demand for long-acting injectables which improve adherence rates.

According to industry reports, the global GnRH analogs market, including leuprolide acetate, is projected to reach USD 5.4 billion by 2027, growing at a CAGR of approximately 6%. The growth fundamentally hinges on expanding indications, escalating prevalence of targeted diseases, and advances in drug delivery technologies.

Market Drivers

1. Rising Disease Prevalence

Prostate cancer remains the most prevalent indication for leuprolide acetate, especially in aging male populations. According to the World Health Organization (WHO), prostate cancer accounted for over 375,000 deaths in 2020, with incidence rates climbing globally, particularly in North America and Europe—key markets for leuprolide products [1].

Similarly, the increasing incidence of breast cancer and endometriosis in women drives demand for hormone suppression therapies. The demographic trend of aging populations further amplifies these needs, supporting sustained market growth.

2. Advances in Long-Acting Formulations

Depot suspensions offer enhanced patient compliance owing to less frequent administration — crucial for chronic disease management. The development of micro-sphere and nano-particle delivery systems further prolongs drug release, extending dosing schedules, and reducing healthcare burdens.

3. Patent Expiries and Generic Entry

Original biologics, such as once-daily GnRH formulations, are facing patent expiries, encouraging generic manufacturers to introduce cost-effective alternatives. The entrance of biosimilars is anticipated to increase market competition, exerting downward pressure on prices but expanding overall market volume.

4. Expanding Indications and Off-Label Uses

Research explorations into additional indications, including endometrial ablation and off-label uses, may diversify revenue streams. Regulatory approvals for novel indications will enhance market footprint.

Market Challenges

1. Price Competition and Biosimilar Entry

Biosimilars and generics threaten to erode margins, especially in highly commoditized markets. Key players are investing in lifecycle management strategies, such as formulation improvements or new delivery systems, to sustain profitability.

2. Regulatory and Reimbursement Policies

Varying approval pathways and reimbursement frameworks across countries create complexities. While some regions offer favorable policies, others impose stringent cost-effectiveness evaluations, impacting pricing strategies and sales volumes.

3. Manufacturing and Supply Chain Constraints

The complex manufacturing processes for biological depot formulations necessitate advanced facilities, element of supply chain vulnerabilities, and quality assurance, which can influence market release timelines and costs.

Financial Trajectory and Revenue Projections

Current Market Valuation and Outlook

Based on current sales data, leuprolide acetate depot formulations generate estimated global revenues exceeding USD 1.2 billion annually, with North America representing roughly 45-50% of this. The key players include AbbVie (brand: Lupron), Pfizer, and smaller biosimilar entrants.

Forecasted Growth Trends

Forecasts predict a compound annual growth rate (CAGR) of 5-6% over the next five years. The growth will primarily originate from:

• Increased adoption: Expanding in emerging markets such as Asia-Pacific owing to increasing healthcare investments and rising disease prevalence.
• New formulations: Introducing extended-release variants and needle-free systems to improve patient experience.
• Pipeline innovations: Next-generation implants and implantable devices could open new revenue avenues.

Impact of Biosimilars and Price Dynamics

Biosimilar competition is expected to impact wholesale prices by 10-20% over the next three years, influencing revenue streams. Nonetheless, volume growth owing to expanding indications and geographic penetration could offset price erosions.

Emerging Opportunities

Investments in personalized medicine and combination therapies integrating leuprolide acetate could counteract generic competition, safeguarding margins. Moreover, strategic licensing and partnership deals in emerging markets will accelerate revenue accrual.

Regulatory and Market Access Considerations

Regulatory agencies such as the FDA and EMA continue to approve new indications, and fast-track approvals for novel delivery systems are anticipated. Market access strategies, including favorable reimbursement policies, are crucial for revenue realization, particularly in cost-sensitive markets.

Conclusion

Leuprolide acetate for depot suspension occupies a stable and ascending trajectory within the hormonal therapy space. Its longstanding efficacy, combined with innovations in sustained-release technologies and expanding clinical applications, underpin sustained revenue growth. However, competitive pressures from biosimilars, regulatory challenges, and evolving pricing landscapes necessitate strategic agility.

Key Takeaways

• The global market for leuprolide acetate depot formulations is expected to grow at a CAGR of approximately 6%, projected to reach USD 5.4 billion by 2027.
• Rising prevalence of prostate and breast cancers, alongside advancements in long-acting formulations, are key drivers.
• Biosimilar entrants and price competition pose significant challenges, requiring differentiation through novel formulations and indications.
• Strategic expansion into emerging markets and pipeline innovation are vital to sustaining revenue growth.
• Regulatory developments and market access policies will significantly influence the financial trajectory of leuprolide acetate depot products.

FAQs

1. How does the depot suspension formulation improve patient compliance?
Depot suspension formulations extend the dosing interval from daily to monthly or quarterly, reducing the frequency of injections. This minimizes treatment burden, improves adherence, and lowers the risk of missed doses, especially beneficial in chronic therapies.

2. What are the primary indications for leuprolide acetate depot formulations?
Indications include hormone-sensitive prostate cancer, estrogen-dependent breast cancer, endometriosis, central precocious puberty, and uterine fibroids. Ongoing research explores additional off-label and investigational uses.

3. How will biosimilar entry impact the leuprolide market?
Biosimilars are expected to exert price pressures, potentially reducing revenue per unit. However, increased volume sales and expanded indications can offset margin compression, maintaining overall market growth.

4. Which regions are expected to see the highest growth for leuprolide depot formulations?
North America and Europe currently lead; however, emerging markets in Asia-Pacific, Latin America, and the Middle East are projected to experience high growth rates owing to increasing healthcare infrastructure and disease burdens.

5. What innovations are likely to influence the future financial trajectory of leuprolide acetate?
Next-generation delivery systems, such as implantable devices, needle-free injectables, and combination therapies with targeted agents, will shape product pipelines and diversify revenue streams.

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Sources
[1] World Health Organization. Global Cancer Observatory: Cancer Today, 2020.