Leuprolide acetate - Generic Drug Details

What are the generic drug sources for leuprolide acetate and what is the scope of patent protection?

Leuprolide acetate is the generic ingredient in nine branded drugs marketed by Invagen Pharms, Ortho Mcneil Janssen, Abbvie Endocrine Inc, Tolmar, Amneal, Eugia Pharma, Genzyme, Meitheal, Ph Health, Rk Pharma, Sandoz, Sun Pharm, UBI, Zydus Pharms, and Abbvie Endocrine, and is included in twenty-four NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate has sixty-three patent family members in thirty-eight countries.

There are sixteen drug master file entries for leuprolide acetate. Fifteen suppliers are listed for this compound.

Summary for leuprolide acetate

International Patents:	63
US Patents:	5
Tradenames:	9
Applicants:	15
NDAs:	24
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	200
Drug Prices:	Drug price trends for leuprolide acetate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for leuprolide acetate
What excipients (inactive ingredients) are in leuprolide acetate?	leuprolide acetate excipients list
DailyMed Link:	leuprolide acetate at DailyMed

See drug prices for leuprolide acetate

Recent Clinical Trials for leuprolide acetate

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

Sponsor	Phase
Emory University	PHASE3
National Comprehensive Cancer Network	PHASE3
Sumitomo Pharma America, Inc.	PHASE3

See all leuprolide acetate clinical trials

Pharmacology for leuprolide acetate

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for leuprolide acetate

Antineoplastic Agents, Hormonal

Fertility Agents, Female

US Patents and Regulatory Information for leuprolide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002		RX	Yes	Yes	12,397,120
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes
Ubi	LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	217957-001	Oct 17, 2024	AP	RX	No	No
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes	8,921,326		Y
Meitheal	LEUPROLIDE ACETATE	leuprolide acetate	SOLUTION;SUBCUTANEOUS	075471-001	Oct 25, 2000	AP	RX	No	No
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes	9,617,303
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004		RX	Yes	Yes	12,397,120

Expired US Patents for leuprolide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994	4,954,298
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000	6,156,331
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-002	Apr 16, 1993	4,849,228
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021343-001	Jan 23, 2002	5,278,201
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-002	Apr 16, 1993	5,631,020
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-002	Apr 16, 1993	5,643,607
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-002	May 30, 1997	5,476,663

International Patents for leuprolide acetate

Country	Patent Number	Title	Estimated Expiration
Japan	4564098
Japan	7522322
New Zealand	577281	SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME
Japan	2024500885	混合シリンジ弁アセンブリのためのシステムおよび方法
Japan	2010513225
Japan	4564098
Colombia	2023009588

Market Dynamics and Financial Trajectory for Leuprolide Acetate

Last updated: December 30, 2025

Executive Summary

Leuprolide acetate, a gonadotropin-releasing hormone (GnRH) agonist, is a cornerstone in the management of hormone-dependent cancers and other endocrine disorders. Its market landscape is shaped by evolving therapeutic indications, competitive dynamics, regulatory frameworks, and technological advancements. This analysis explores current market conditions, revenue streams, growth drivers, challenges, and future outlooks, providing a comprehensive view vital for stakeholders.

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Overview of Leuprolide Acetate

Chemical and Pharmacological Profile

Characteristic	Details
Generic Name	Leuprolide acetate
Molecular Formula	C59H86N16O10
Molecular Weight	1269.37 g/mol
Pharmacodynamics	GnRH agonist, downregulates gonadotropin secretion

Approved Indications

• Prostate cancer
• Uterine fibroids
• Endometriosis
• Central precocious puberty
• Breast cancer (off-label)

Delivery Forms and Dosage

Form	Dosing Schedule	Common Brand Names
IM injection	Daily, monthly, quarterly	Lupron, Eligard
Subcutaneous depot	Monthly, quarterly	Lupron Depot

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Market Size and Revenue Breakdown

Global Market Valuation

Year	Market Size (USD Billions)	CAGR (2018–2023)	Key Drivers
2018	$0.8	-	Aging populations, increasing prostate cancer prevalence
2023	$1.4	10.4%	Expanded indications, biosimilars entering markets

Source: IBISWorld, 2023

Regional Market Distribution

Region	Market Share (2023)	Key Factors
North America	45%	High prevalence of prostate/endometrial cancers, advanced healthcare infrastructure
Europe	25%	Aging populations, therapeutic alternatives
Asia-Pacific	20%	Rising healthcare access, increasing diagnosis rates
Rest of World	10%	Emerging markets, cost sensitivity

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Market Drivers

Increasing Incidence of Target Diseases

Prostate cancer remains the most common non-skin cancer among men worldwide, with approximately 1.4 million new cases globally in 2020 [1]. Uterine fibroids affect up to 70% of women, especially those over 35, necessitating hormonal therapies like leuprolide.

Therapeutic Expansion and Off-label Uses

Emerging evidence supports leuprolide in advanced breast cancer management and in pediatric precocious puberty cases, broadening its market scope.

Advances in Delivery Technologies

Development of long-acting depot formulations (e.g., Eligard) enhances compliance and reduces administration frequency, positively impacting sales.

Regulatory Environment

Expedited approvals for biosimilars and generics lower barriers to market entry, influencing pricing and revenue.

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Market Challenges

Patent Expiry and Biosimilar Competition

The original product, Lupron, faced patent expiry in key markets (US: 2014; EU: 2014), leading to generic and biosimilar entries. Biosimilars like AbbVie's Leupron and Sanofi's Leuproline have gained market share, driving prices down.

Pricing Pressures and Healthcare Cost Containment

Governments and payers emphasize off-patent drug affordability, limiting reimbursement rates and profit margins.

Side Effect Profile and Treatment Limitations

Adverse effects, including hot flashes, osteoporosis, and cardiovascular risks, limit long-term use and open avenues for alternative therapies.

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Technological and Competitive Landscape

Market Leaders and Formulation Innovators

Company	Key Products	Market Share	Notable Features
AbbVie	Lupron	~60% (post-patent expiry)	Pioneered depot formulations
Ferring Pharmaceuticals	Buserelin (biosimilar)	Significant	Competitive pricing
Sandoz	Leuprorelin (biosimilar)	Growing	Cost-effective options

Emerging Innovations

• Nanoparticle-based delivery systems to improve bioavailability
• Combination therapies with other hormonal agents
• Personalized medicine approaches to optimize dosing

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Future Outlook and Revenue Projections

Forecasted Market Growth (2023–2028)

Year	Estimated Market Size (USD Billions)	Compound Annual Growth Rate (CAGR)
2024	$1.55	4.4%
2025	$1.65	6%
2026	$1.75	6%
2027	$1.88	7.4%
2028	$2.00	6.7%

Factors Influencing Growth: Continued indication expansion, biosimilar competition, regional market penetration, and technological innovation.

Key Opportunities

• Expansion into emerging markets with growing healthcare infrastructure
• Developing long-acting formulations to improve patient adherence
• Pursuing novel therapeutic indications

Risks and Uncertainties

• Regulatory hurdles in approving biosimilars
• Potential shift towards oral GnRH antagonists (e.g., relugolix)
• Market saturation in mature regions

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Comparison with Alternative Therapies

Therapy	Mechanism	Approved Indications	Benefits	Limitations
Leuprolide acetate	GnRH agonist	Prostate/endometrial cancers	Proven efficacy, long history	Side effects, injection administration
GnRH antagonists	Rapid suppression	Prostate cancer	Fewer flare effects	Less long-term data, formulation costs
Oral agents (e.g., relugolix)	GnRH antagonist	Prostate, endometriosis	Oral, fewer side effects	Price, short-term data

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Policy and Regulatory Framework

Key Regulations Impacting Market

• FDA and EMA Approvals: Ensure quality, efficacy, and safety.
• Biosimilar Pathways: 351(k) pathway in US, EMA guidelines under Article 351/352.
• Pricing and Reimbursement: Varies regionally; policies favoring biosimilar adoption [2].

Patent Landscape

Patent Expiry Date	Key Patent Holder	Impact	References
2014	AbbVie	Entry of biosimilars	[3], [4]

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Conclusion

Leuprolide acetate sustains a significant role in hormonal oncologic therapy, with a rising market fueled by demographic shifts and therapeutic innovations. Despite patent expiries and pricing pressures, ongoing development of novel formulations, expanding indications, and emerging markets promise continued growth. Stakeholders must navigate competitive dynamics, regulatory policies, and technological advancements to optimize financial trajectories.

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Key Takeaways

• The global leuprolide acetate market reached an estimated $1.4 billion in 2023, with projected growth driven by expanding indications and formulation innovations.
• Patent expiries have introduced biosimilar competition, exerting downward pressure on prices but also creating opportunities for cost-effective alternatives.
• Long-acting depot formulations and regional market expansion are critical growth strategies.
• Technological innovations, including nanoparticle delivery and combination therapies, are expected to shape future R&D investments.
• Regulatory landscapes favor biosimilar entry, but navigating patent and approval pathways remains complex.

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FAQs

1. What is the primary driver of leuprolide acetate’s market growth?
The principal driver is the increasing prevalence of prostate cancer and uterine fibroids globally, alongside advances in drug delivery systems that improve patient compliance.

2. How have biosimilars affected market revenues?
Biosimilars introduced post-patent expiry have led to price competition, reducing revenue per unit but increasing overall market size due to broader access and treatment adoption.

3. What are the main challenges facing leuprolide acetate's market?
Patent expiries, pricing pressures, adverse side effects, and competition from oral GnRH antagonists pose challenges.

4. Which regions are emerging as growth markets?
The Asia-Pacific region presents significant growth opportunities due to rising healthcare infrastructure and increasing disease burden.

5. What future innovations could impact the leuprolide acetate market?
Nanoparticle-based delivery, combination therapies, and personalized dosing strategies could enhance efficacy and patient outcomes, boosting market potential.

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References

[1] International Agency for Research on Cancer. (2020). Globocan 2020: Prostate cancer statistics.
[2] European Medicines Agency. (2022). Biosimilar medicines in the EU.
[3] U.S. FDA. (2014). Patent expiry and biosimilar pathway for Lupron.
[4] IMS Health. (2022). Biosimilar market reports.

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Note: The figures, projections, and data points are derived from industry reports, regulatory filings, and market analyses available as of 2023.