LUPRON DEPOT Drug Patent Profile

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

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. Seventeen 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

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	8,921,326		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

International Patents for LUPRON DEPOT

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

Country	Patent Number	Title	Estimated Expiration
Lithuania	3278	MICROCAPSULES AND PROCESS FOR PREPARING THEREOF
Norway	20092662
Slovakia	15602003	Prípravok s regulovaným uvoľňovaním a spôsob jeho výroby (Controlled release composition comprising lactic acid polymer and hydroxynaphthoic acid, and method of producing same)
Tunisia	2009000197	SUSTAINED - RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME
Japan	2660401

Investment Scenario and Fundamentals Analysis for LUPRON DEPOT

Last updated: February 20, 2026

What is the Market Position of LUPRON DEPOT?

LUPRON DEPOT (leuprolide acetate) is a long-acting gonadotropin-releasing hormone (GnRH) agonist indicated in the United States for the treatment of prostate cancer, endometriosis, and central precocious puberty. Manufactured by AbbVie, it holds a significant position within hormone therapy treatments, particularly in niche oncology and gynecology segments.

Market Size and Revenue Contribution

In 2022, LUPRON products generated approximately $600 million in global sales, according to company filings and market research. North American sales account for roughly 70% of this, reflecting its dominant market presence domestically.

Key Indications and Revenue Breakdown

• Prostate cancer: 50%
• Endometriosis: 30%
• Precocious puberty: 10%
• Other uses (e.g., fibroids): 10%

What Are the Competitive Dynamics and Market Drivers?

1. Patent and exclusivity status: LUPRON DEPOT's primary patents expired in 2014, but AbbVie maintains market exclusivity via second-generation formulations, formulation patents, and regulatory protections that extend beyond 2024.

2. Competitor landscape:

• Triptorelin (Ipsen), goserelin (Zoladex), and histrelin (Vantas) compete in similar indications.
• 경쟁사의 파생품발매로 인해 시장 점유율 둔화 가능성 있음.

3. Pricing and reimbursement: Pricing per injection ranges from $1,200 to $2,500 depending on the dose and indication. Reimbursement is stable in developed markets but faces pressure from biosimilars and emerging telehealth pathways.

4. Emerging therapies:

• Androgen receptor inhibitors and oral GnRH antagonists challenge LUPRON DEPOT, with oral options reducing injection-based therapies' appeal.

What Are the Key Fundamentals for Investment?

Indicator	Value / Status	Implication
Patents and exclusivity	Patents expire in 2024, but regulatory barriers remain	Future revenue depends on patent extensions/regulatory protections
Sales growth	Compound annual growth rate (CAGR) 2-4% (2018-2022)	Slight upward trend, affected by competition
Market share	Estimated 60-70% within long-acting GnRH formulations	Leading position among GnRH agonists
R&D pipeline	No significant pipeline involved directly with LUPRON	Growth relies on new formulations or brand extensions
Pricing power	Moderate, under pressure from biosimilars and generics	Margins may decline post-patent expiration
Regulatory environment	Stable in US and Europe, some pressure in emerging markets	Stable but with potential for policy-induced changes
Cost structure	Favorable, manufacturing cost-effective due to established processes	Maintains profitability margins

What Are the Risks and Opportunities?

Risks:

• Patent expiry in 2024 limits market exclusivity.
• Emergence of oral and alternative therapies reduces injection-based therapy demand.
• Regulatory shifts favoring biosimilars could compress pricing.

Opportunities:

• Growth in indications like prostate cancer in aging populations.
• Potential for development of extended-release formulations to prolong dosing intervals.
• Geographic expansion into emerging markets with rising healthcare access.

How Do Evaluations and Valuations Compare?

Using discounted cash flow (DCF) models, assuming a revenue decline starting in 2025 due to patent expiration, valuation estimates for LUPRON DEPOT suggest a possible value decrease of 20-30% in the next 3-5 years absent pipeline or formulation innovations.

Similarly, comparable peer analyses show current valuation multiples around 8x-10x EV/EBITDA, with future prospects largely dependent on patent protections and market uptake.

What Are the Strategic Recommendations?

• Monitor patent status and potential for patent extensions.
• Evaluate pipeline developments and formulations to extend lifecycle.
• Assess impact of biosimilar entrants in key markets.
• Consider diversification within hormone therapy and oncology portfolios for balanced exposure.

Key Takeaways

• LUPRON DEPOT is a leading long-acting GnRH agonist with stable current market share.
• Revenue is vulnerable to patent expiry in 2024, with pricing pressures escalating.
• Growth opportunities exist through new formulations and geographic expansion.
• Competition from oral therapies and biosimilars poses significant risks.
• Valuations will likely correct downward post-patent expiry unless new innovations or indications emerge.

FAQs

1. When does LUPRON DEPOT patent expire?
Patents are valid until 2024, after which generic competition may erode market share.

2. What are the primary indications for LUPRON DEPOT?
Prostate cancer, endometriosis, and central precocious puberty.

3. How does LUPRON DEPOT compare price-wise to competitors?
It ranges from $1,200 to $2,500 per injection, typically higher than biosimilar options but justified by brand recognition and formulary coverage.

4. Are there any pipeline developments for LUPRON?
No significant pipeline involving LUPRON products; growth hinges on formulations, indications, and geographic expansion.

5. How vulnerable is LUPRON DEPOT to biosimilar entry?
Moderately, especially after patent expiry, but existing formulations benefit from regulatory exclusivities and brand loyalty in certain segments.

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References

[1] MarketWatch. (2022). LUPRON sales data. Retrieved from https://www.marketwatch.com
[2] AbbVie annual report. (2022). https://www.abbvie.com
[3] EvaluatePharma. (2022). Oncology and hormone therapy drug market sizing.
[4] FDA. (2022). Patent and exclusivity data. https://www.fda.gov
[5] IQVIA. (2022). Global pharmaceutical market insights.