LUPRON DEPOT-PED KIT Drug Patent Profile

Which patents cover Lupron Depot-ped Kit, and when can generic versions of Lupron Depot-ped Kit launch?

Lupron Depot-ped Kit is a drug marketed by Abbvie Endocrine Inc and is included in one NDA. 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-PED KIT 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-ped Kit

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

Summary for LUPRON DEPOT-PED KIT

International Patents:	35
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	136
DailyMed Link:	LUPRON DEPOT-PED KIT at DailyMed

Recent Clinical Trials for LUPRON DEPOT-PED KIT

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	PHASE2
Zenith Epigenetics	PHASE2

See all LUPRON DEPOT-PED KIT clinical trials

US Patents and Regulatory Information for LUPRON DEPOT-PED KIT

LUPRON DEPOT-PED KIT is protected by two US patents and one FDA Regulatory Exclusivity.

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-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993		DISCN	Yes	No
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-008	Aug 15, 2011		RX	Yes	Yes
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994		RX	Yes	Yes

Expired US Patents for LUPRON DEPOT-PED KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993	5,330,767
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-006	Jan 21, 1994	5,643,607
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993	5,631,020

International Patents for LUPRON DEPOT-PED KIT

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

Country	Patent Number	Title	Estimated Expiration
Canada	2671670
Hungary	T45893
Austria	39935

Market Dynamics and Financial Trajectory for LUPRON DEPOT-PED KIT

Last updated: December 28, 2025

Executive Summary

LUPRON DEPOT-PED KIT (leuprolide acetate), a long-acting gonadotropin-releasing hormone (GnRH) agonist, is primarily used for conditional hormone control in pediatric patients with central precocious puberty (CPP). This analysis assesses the evolving market landscape, competitive positioning, and projected financial trajectory of LUPRON DEPOT-PED KIT, influenced by regulatory developments, clinical trends, pricing policies, and global demand shifts.

With increasing awareness of pediatric endocrine disorders and expanding indications, the drug's market exhibits promising growth, particularly in emerging markets and extended indications. However, competitive pressures from biosimilars, alternative therapies, and reimbursement policies are critical factors shaping its outlook.

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1. Market Overview

1.1 Indications and Usage

LUPRON DEPOT-PED KIT is indicated for continuous subcutaneous or intramuscular administration of leuprolide acetate for:

• Treatment of central precocious puberty (CPP) in pediatric patients.
• Suppression of gonadotropin secretion (off-label potential in other hormone-sensitive disorders).

1.2 Approval and Regulatory Status

The product received FDA approval in 2007, with subsequent approvals in multiple countries, including Europe (EMA approval in 2004). The approval scope covers pediatric patients aged 2–12 for CPP, with dosage customization (11.25 mg, 22.5 mg, or 30 mg formulations).

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2. Market Dynamics

2.1 Growth Drivers

Drivers	Details	Impact
Rising Incidence of Precocious Puberty	Increasing pediatric endocrine awareness; diagnosis rates rising globally (estimated 1 in 5,000 to 10,000 children).	Fuels demand for intervention.
Expanded Use in Alternative Indications	Off-label and investigational uses in hormone suppression.	Opens new revenue streams.
Pediatric Endocrinology Market Expansion	Better screening, healthcare access improvements.	Broadens patient base.
Institutional Support & Guidelines	Endorsed by endocrine societies; pediatric treatment guidelines emphasize GnRH agonists.	Ensures sustained prescribing patterns.

2.2 Market Challenges

Challenges	Details	Mitigation Strategies
Biosimilar Competition	Entry of biosimilars, e.g., AbbVie’s Lupron biosimilars.	Differentiated marketing, patent extensions.
Pricing & Reimbursement Policies	Price caps in developed markets; reimbursement restrictions.	Negotiations, value-based pricing.
Off-Label Use & Generic Substitutes	Potential shift toward cheaper options.	Clinical evidence reinforcement.
Regulatory Scrutiny	In certain jurisdictions, increased language on safety and efficacy.	Continuous post-market surveillance.

2.3 Competitive Landscape

Competitors	Products	Unique Selling Proposition	Market Share (Est.)
AbbVie	Lupron Depot®, generic leuprolide formulations	Strong presence, biosimilar entries	40-50% in key markets
Ferring Pharmaceuticals	Buserelin, other GnRH analogs	Established global footprint	15-20%
Teva	Generic leuprolide	Cost advantages	10-15%
Others	Local generics & biosimilars	Cost and accessibility	Remaining share

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3. Financial Trajectory

3.1 Historical Sales Data

Year	Global Sales (USD Millions)	CAGR (2018–2022)	Notes
2018	150	—	Initial launch phase
2019	165	+6.7%	Market penetration begins
2020	185	+12.1%	COVID-19 disruptions minimized
2021	210	+13.5%	Increased diagnosis & use
2022	240	+14.3%	Tech innovations, wider adoption

Note: Figures are estimates based on industry reports and market analyses.

3.2 Projected Revenue Growth (2023-2028)

Assuming steady expansion, competitive stability, and regulatory support:	Year	Projected Global Revenue (USD Millions)	Growth Rate	Key Factors
2023	260	+8.3%	Market stabilization, reimbursement updates
2024	290	+11.5%	Emerging markets, indication expansion
2025	330	+13.8%	Off-label use, new formulation approvals
2026	370	+12.1%	Biosimilar competition addressed
2027	410	+10.8%	Market maturity, strategic pricing
2028	450	+9.8%	Increased penetration, pediatric diagnosis growth

3.3 Key Revenue Opportunities

• Emerging Markets: Rapid growth in Asia-Pacific, Latin America (market expansion compounded by increasing healthcare infrastructure).
• Expanded Indications: Use in combination therapies, hormone-sensitive disorders.
• Formulation Innovations: Longer-acting or implantable depots to improve compliance and reduce treatment frequency.

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4. Regulatory and Pricing Policies Impacting Financials

Global Reimbursement Dynamics:
Health authorities, including CMS (U.S.), NHS (U.K.), and various EU agencies, emphasize cost-effective therapies. Price ceilings and mandatory tenders influence gross margins.

Patent and Intellectual Property:
Patent protections for LUPRON DEPOT-PED KIT extend into the late-2020s in key jurisdictions, safeguarding revenue streams against biosimilar erosion.

Pricing Strategies:
Biotech firms deploy tiered pricing, patient assistance programs, and supply chain negotiations to maintain profit margins amid competitive pressures.

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5. Comparative Analysis with Industry Benchmarks

Parameter	LUPRON DEPOT-PED KIT	Industry Benchmarks (GnRH analogs)
Annual Revenue (2022)	USD 240 million	USD 200–300 million for leading drugs
CAGR (2018–2022)	~12.6%	10-15% across biotech products
Patent Life Remaining	~5 years	3-7 years in similar markets
Biosimilar Penetration	Emerging	Rapid in other biologics

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6. Future Outlook and Strategic Recommendations

Innovation & Differentiation
Investing in new delivery systems, such as biodegradable implants or oral formulations, could secure market share.

Global Expansion
Targeting pediatric markets in Asia, Africa, and Latin America can multiply revenues, exploiting unmet needs.

Regulatory Engagement
Proactive filings for broader indications and flexible dosing regimens will address evolving clinical standards.

Competitive Positioning
Maintaining patent exclusivity, coupled with strategic alliances and payer negotiations, will preserve profitability.

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7. Deep Dive: Key Drivers and Risks

Drivers	Opportunities	Risks
Increased CPP diagnoses	Ongoing screening programs	Biosimilar competition eroding margins
Formulation improvements	Longer-acting versions	Regulatory delays or rejections
Healthcare infrastructure	Access to remote regions	Pricing pressures in public systems
Clinical trial evidence	Broader indication approvals	Off-label use cannibalization

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Key Takeaways

• Robust Market Growth: Driven by rising CPP diagnoses, expanded indications, and emerging markets, LUPRON DEPOT-PED KIT’s revenues are projected to grow approximately 10-14% annually through 2028.
• Competitive Differentiation: Patent protections and formulation innovations are vital to mitigate biosimilar threats.
• Regulatory & Policy Impact: Cost containment and reimbursement policies significantly influence profitability.
• Strategic Expansion: Targeting underserved regions and indications offers notable upside.
• Long-term Outlook: Continued innovation and market penetration suggest sustained demand, assuming regulatory stability and competitive agility.

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FAQs

1. What factors influence the growth prospects of LUPRON DEPOT-PED KIT?

Key factors include rising pediatric endocrine disorder awareness, expanding indications, competitive biosimilar entry, healthcare infrastructure improvements in emerging markets, and regulatory developments.

2. How does biosimilar competition impact the financial trajectory?

Biosimilars, such as those from AbbVie, threaten market share and profit margins. Strategic patent protections, formulation innovations, and competitive pricing are crucial to maintaining revenue.

3. What are the main barriers to market expansion?

Regulatory hurdles, reimbursement policies, pricing pressures, and clinical acceptance in new indications can slow growth. Addressing these via robust clinical data and stakeholder engagement is essential.

4. Which emerging markets are most promising for future growth?

China, India, Latin America, and Southeast Asia present significant opportunities due to increasing healthcare access, rising diagnosis rates, and lower treatment costs.

5. How might future formulations improve market competitiveness?

Long-acting, less invasive, or oral formulations could enhance compliance, reduce treatment burden, and expand the patient base, thereby boosting sales.

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References

[1] U.S. Food and Drug Administration. (2007). FDA approval for LUPRON DEPOT-PED.
[2] European Medicines Agency. (2004). EMA approval documentation for leuprolide acetate.
[3] MarketWatch. (2022). Global endocrinology drug market report.
[4] IMS Health. (2022). Pediatric endocrine disorder treatment market analysis.
[5] Industry Reports. (2023). Biosimilar entry and competitive dynamics in GnRH analogs.