LUPRON DEPOT-PED KIT Drug Patent Profile

Which patents cover Lupron Depot-ped Kit, and what generic alternatives are available?

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
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes	9,617,303
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-002	Apr 16, 1993		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	020263-002	Apr 16, 1993	4,677,191
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-002	Apr 16, 1993	4,005,063
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-005	Jan 21, 1994	5,716,640
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-006	Jan 21, 1994	4,954,298
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993	4,954,298

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
Eurasian Patent Organization	016176	КОМПОЗИЦИЯ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ И СПОСОБ ЕЁ ПОЛУЧЕНИЯ (SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME)
Hungary	T43488
Canada	1260395	PRODUCTION DE MICROCAPSULES (METHOD FOR PRODUCING MICROCAPSULE)
Brazil	PI0720582
South Korea	101522035

Market Dynamics and Financial Trajectory for LUPRON DEPOT-PED KIT

Last updated: July 28, 2025

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Introduction

LUPRON DEPOT-PED KIT, developed by Takeda Pharmaceuticals, is a long-acting gonadotropin-releasing hormone (GnRH) agonist formulation used primarily in veterinary medicine for management of reproductive hormone-related conditions in dogs and cats. Its proprietary sustained-release technology ensures consistent therapeutic levels, promoting regulated gonad activity. Given its specific niche in veterinary endocrinology, understanding its market dynamics and financial trajectory involves an analysis of both regulatory, competitive, and market demand factors within veterinary therapeutics and the broader pharmaceutical landscape.

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Market Overview for Veterinary Reproductive Pharmaceuticals

The global veterinary drugs market is estimated to reach approximately USD 26 billion by 2025, with a compounded annual growth rate (CAGR) of around 6% [1]. Within this, reproductive health drugs such as LUPRON DEPOT-PED KIT occupy a specialized segment, driven by increasing demand for fertility management, contraception, and hormone-related treatments in companion animals.

The adoption of veterinary hormonal therapies is influenced by rising pet ownership, heightened awareness of pet health, advancements in veterinary diagnostics, and humane population control policies. Regulatory approval trends in key markets such as North America, Europe, and Asia-Pacific further shape growth prospects, with particular interest in minimally invasive, long-acting formulations that improve compliance and reduce treatment frequency.

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Market Dynamics Influencing LUPRON DEPOT-PED KIT

1. Growing Pet Ownership and Humanization of Pets

The rising number of pet owners seeking premium healthcare services for their animals significantly boosts demand for innovative pharmaceuticals. In North America and Europe, pet humanization trends have led to increased investments in reproductive health therapies, often paralleling human medical advancements.

2. Regulatory Environment and Approvals

Regulatory agencies such as the USDA (United States Department of Agriculture) and EMA (European Medicines Agency) oversee veterinary pharmaceuticals, emphasizing safety, efficacy, and animal welfare. Fast-track approvals and supportive legislation for reproductive health innovations facilitate market entry and expansion of products like LUPRON DEPOT-PED KIT.

3. Competition and Differentiation

The market for veterinary reproductive drugs includes alternatives such as deslorelin implants, progestins, and surgical options. LUPRON DEPOT-PED KIT’s unique sustained-release technology offers advantages in dosing convenience and reduced administration frequency. However, competition from emerging biodegradable implant technologies and novel hormonal agents necessitates continual innovation.

4. Cost and Price Sensitivity

Veterinary pharmaceuticals often face cost constraints due to pet owner willingness to pay and insurance coverage limitations. The pricing of LUPRON DEPOT-PED KIT influences its market penetration, especially in markets with high competition from cost-effective generic or off-label medications.

5. Veterinary Practice Adoption and Education

The successful adoption hinges on veterinary practitioners' familiarity and comfort with GnRH-based therapies. Educational initiatives and clinical trials demonstrating efficacy and safety bolster confidence in prescribing LUPRON DEPOT-PED KIT, fostering broader market acceptance.

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Financial Trajectory and Revenue Projections

Historical Performance and Market Penetration

While exact sales figures for LUPRON DEPOT-PED KIT are proprietary, its inclusion within Takeda’s veterinary portfolio signifies strategic importance. The product benefits from Takeda's established global distribution channels and reputation for rare and specialty medicines.

Key Revenue Drivers

• Increased pet ownership and demand for reproductive health management
• Expanding geographic footprint, especially in emerging markets
• Appropriate pricing aligned with veterinary clinics’ budgets

Forecasted Growth and Challenges

Analysts project the veterinary reproductive drug segment to grow at a CAGR of 7% over the next five years, driven largely by innovations in sustained-release formulations and increasing pet wellness spending [2].

However, LUPRON DEPOT-PED KIT faces challenges such as market saturation in mature regions, regulatory hurdles in certain jurisdictions, and potential off-label use concerns that could influence revenue streams.

Emerging Opportunities

The development of adjunct therapies, combination treatments, and expanded indications (e.g., hormone-sensitive cancers in animals) can augment LUPRON DEPOT-PED KIT’s financial trajectory. Additionally, growing awareness and pet owner acceptability are expected to enhance market adoption.

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Regulatory and Patent Landscape

The patent life of LUPRON DEPOT-PED KIT influences its market exclusivity and revenue potential. Takeda’s strategic patent filings extending protection and regulatory approvals in diverse jurisdictions are critical to maintaining competitive advantage.

Regulatory pathways for veterinary drugs are generally less complex than human pharmaceuticals but still require rigorous efficacy and safety data. Post-approval monitoring and compliance influence long-term profitability.

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Market Entry and Expansion Strategies

Takeda’s approach to maximizing the product’s financial potential involves strategic collaborations with veterinary clinics, educational outreach, and partnerships with distributors. Emphasizing the long-acting benefits, safety profile, and ease of administration enhances market acceptance.

Expansion into emerging markets, where pet ownership rates are rising and veterinary infrastructure is developing, remains a significant opportunity. Tailored pricing strategies, local regulatory engagement, and cultural considerations are essential components of this expansion plan.

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Conclusion

The market dynamics surrounding LUPRON DEPOT-PED KIT are shaped by pet ownership trends, regulatory landscapes, and technological innovations in veterinary pharmaceuticals. Its financial trajectory is poised for growth, supported by increasing demand for effective, long-acting reproductive therapies, especially in developed markets. Nonetheless, competition, pricing sensitivities, and regulatory variances will continue to influence its revenue potential. Strategic positioning, innovation, and expanded market penetration will be pivotal in optimizing its long-term financial performance.

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Key Takeaways

• The veterinary reproductive drug market is expanding, driven by pet humanization and rising wellness investments.
• LUPRON DEPOT-PED KIT’s sustained-release technology offers competitive advantages but faces market competition from alternative hormonal therapies.
• Revenue growth hinges on geographic expansion, effective veterinary education, and navigating regulatory pathways.
• The product’s patent status and regulatory approvals will significantly influence its market exclusivity and profitability.
• Future opportunities include expanding indications and entering emerging markets with adaptative pricing strategies.

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FAQs

1. What are the primary indications for LUPRON DEPOT-PED KIT?
LUPRON DEPOT-PED KIT is primarily used to suppress reproductive hormones in dogs and cats, aiding in contraception, estrus suppression, and management of hormone-sensitive conditions.

2. How does LUPRON DEPOT-PED KIT differentiate itself from other veterinary reproductive therapies?
Its unique sustained-release formulation provides long-acting hormone suppression, reducing dosing frequency and improving compliance compared to traditional injectable or oral options.

3. What markets offer the most growth potential for LUPRON DEPOT-PED KIT?
North America and Europe currently lead, but emerging markets in Asia-Pacific and Latin America present significant growth opportunities due to rising pet ownership and expanding veterinary infrastructure.

4. Are there any notable regulatory barriers for LUPRON DEPOT-PED KIT?
While the regulatory process is streamlined compared to human drugs, approvals require demonstration of safety and efficacy specific to veterinary species, which may vary by country.

5. What strategies can Takeda deploy to enhance the financial trajectory of LUPRON DEPOT-PED KIT?
Strategies include expanding indications, increasing veterinary practitioner education, forming strategic partnerships, and localizing product offerings in emerging markets.

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Sources:

[1] MarketsandMarkets. "Veterinary Drugs Market by Animal Type, Product, and Region," 2022.
[2] Research and Markets. "Veterinary Pharmaceuticals Market Report," 2022.