SUPPRELIN Drug Patent Profile

When do Supprelin patents expire, and what generic alternatives are available?

Supprelin is a drug marketed by Shire and Endo Operations and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in SUPPRELIN is histrelin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the histrelin acetate profile page.

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Indicators of Generic Entry

Summary for SUPPRELIN

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	2
Patent Applications:	905
Drug Prices:	Drug price information for SUPPRELIN
What excipients (inactive ingredients) are in SUPPRELIN?	SUPPRELIN excipients list
DailyMed Link:	SUPPRELIN at DailyMed

See drug prices for SUPPRELIN

Recent Clinical Trials for SUPPRELIN

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

Sponsor	Phase
Southwest Oncology Group	Phase 3
National Cancer Institute (NCI)	Phase 3
University of Colorado, Denver	Phase 2

See all SUPPRELIN clinical trials

US Patents and Regulatory Information for SUPPRELIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-001	Dec 24, 1991		DISCN	No	No
Endo Operations	SUPPRELIN LA	histrelin acetate	IMPLANT;SUBCUTANEOUS	022058-001	May 3, 2007		RX	Yes	Yes
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-002	Dec 24, 1991		DISCN	No	No
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-003	Dec 24, 1991		DISCN	No	No

Expired US Patents for SUPPRELIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-001	Dec 24, 1991
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-003	Dec 24, 1991
Shire	SUPPRELIN	histrelin acetate	INJECTABLE;INJECTION	019836-002	Dec 24, 1991

International Patents for SUPPRELIN

See the table below for patents covering SUPPRELIN around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	149896
Australia	533348
European Patent Office	0021620	WATER-SOLUBLE PEPTIDES AFFECTING GONADAL FUNCTION
Australia	5866380

Market Dynamics and Financial Trajectory for SUPPRELIN

Last updated: July 28, 2025

Introduction

SUPPRELIN (histrelin implant) is a long-term, biodegradable subcutaneous implant used primarily for the treatment of central precocious puberty (CPP) and other hormonal conditions. Since its approval, SUPPRELIN has carved out a niche within pediatric endocrinology and hormone suppression therapeutics. Its unique delivery system and targeted medical indications influence its market performance and financial trajectory. This analysis explores the current market dynamics, competitive landscape, revenue projections, regulatory environment, and future opportunities shaping SUPPRELIN's financial outlook.

Market Overview

The global market for hormone suppression therapies is expanding, driven by increasing prevalence of endocrine disorders, technological advancements, and growing awareness among healthcare providers. SUPPRELIN's primary indication, CPP, affects approximately 1 in 5,000 to 10,000 children worldwide [1]. Rising diagnosis rates, partly due to improved screening and awareness, augment the demand for effective long-term treatment options like SUPPRELIN.

The implant's design, offering sustained release of gonadotropin-releasing hormone (GnRH) analogs over a year through a minimally invasive procedure, positions it favorably against traditional monthly injections. Its advantages include reduced treatment burden, improved compliance, and steady hormone suppression.

Market Drivers

Increasing Prevalence of Precocious Puberty

An upward trend in the diagnosis of CPP—exacerbated by urbanization, environmental factors, and heightened awareness—has become a significant market driver [2]. Health surveys in North America and Europe demonstrate a 1.5 to 2-fold increase in CPP cases over the past decade, translating into higher demand for long-acting hormone therapies.

Advancements in Drug Delivery Technologies

SUPPRELIN's implant technology appeals to clinicians seeking durable, patient-friendly options. The convenience of annual insertion contrasts favorably with monthly injections, reducing clinic visits and improving adherence—factors especially critical in pediatric populations.

Regulatory Approvals and Off-Label Uses

Beyond the primary indication, SUPPRELIN has garnered off-label interest for adult hormone suppression, gender-affirming therapies, and certain hormonal cancers. Regulatory approvals in multiple jurisdictions extend its potential market, although off-label use remains a grey area impacting sales.

Healthcare Reimbursement Landscape

Insurance coverage and health policy initiatives that favor minimally invasive, cost-effective treatments bolster SUPPRELIN’s market potential. Reimbursement policies in Europe and North America generally support implant-based therapies, although regional differences persist.

Competitive Landscape

SUPPRELIN's principal competitors include:

• Monthly Leuprolide injections (e.g., Lupron Depot) — Offer flexible dosing but require frequent administration, impacting compliance.
• Other GnRH agonist implants — E.g., Zoladex implants, with similar delivery mechanisms but differing indications.
• Emerging treatments — Next-generation implantable or sustained-release formulations under development could influence future competition.

Manufacturers like Endo Pharmaceuticals and AbbVie dominate certain segments, but SUPPRELIN's distinctive long-acting profile maintains its market influence, especially among pediatric endocrinologists prioritizing compliance.

Financial Trajectory

Historical Revenue and Adoption Patterns

Since its initial approval in 2007, SUPPRELIN has experienced incremental growth. Sales initially faced slow uptake owing to limited awareness and regulatory hurdles but gained momentum with broader clinical acceptance and insurance coverage. Peak sales in North America approximately reached several hundred million dollars annually, although exact figures vary based on reporting sources [3].

Revenue Growth Projections

Forecast models project a compound annual growth rate (CAGR) of approximately 5-8% over the next five years, contingent upon several factors:

• Expanded indications: Growth in off-label uses and new formulations.
• Market penetration: Increased adoption in emerging markets like Asia-Pacific, Latin America, and the Middle East.
• Regulatory approvals: In regions where SUPPRELIN is currently unapproved, approval could catalyze sales.

Market Penetration Strategies

Key strategies include targeted medical education, clinician engagement, and partnerships with healthcare systems to facilitate access. Moreover, leveraging patient preference for drug-eluting implants will continue to be instrumental.

Potential Challenges

• Pricing pressures: Governments and insurers advocating for cost containment may negotiate lower reimbursement rates.
• Competition: Introduction of innovative delivery systems could erode market share.
• Regulatory constraints: Differences in approval pathways and off-label usage restrictions may delay market expansion.

Regulatory Environment and Impact

SUPPRELIN's regulatory pathway has been characterized by robust safety and efficacy data submissions. Its approval status varies globally, affecting sales opportunities. Regulatory bodies like the FDA and EMA maintain rigorous standards but also provide pathways for orphan drugs, which benefit SUPPRELIN given the rarity of CPP.

Ongoing dialogue with regulators and adherence to evolving pharmacovigilance standards are crucial for sustaining market access. Recently, efforts to extend indications and optimize delivery profiles have been pursued through supplemental approvals—factors that influence its financial outlook.

Future Opportunities

New Indications

Research suggests potential for SUPPRELIN in managing hormone-sensitive cancers, gender dysphoria, and other endocrine disorders. These new markets can significantly alter its financial trajectory if substantiated through clinical trials and regulatory approval.

Technological Innovation

Advances in biodegradable implant technology, personalized dosing, and combination therapies could evolve SUPPRELIN's profile, offering enhanced efficacy and safety, thereby expanding its market reach.

Global Expansion

Emerging markets present substantial growth opportunities. Tailored strategies to address local healthcare policies, cultural acceptance, and manufacturing costs will unlock increased sales.

Partnerships and Licensing

Collaborations with biotech firms and healthcare providers can accelerate development, distribution, and adoption, improving revenue streams and market penetration.

Key Takeaways

• SUPPRELIN’s market performance hinges on its status as a long-acting, minimally invasive treatment for CPP, with expanding acceptance driven by demographic and technological factors.
• Increasing diagnosis rates of precocious puberty and rising awareness bolster demand, while regulatory approvals in additional regions provide further growth avenues.
• The competitive landscape favors SUPPRELIN’s unique delivery system but requires ongoing innovation to sustain market share amid emerging therapies.
• Revenue projections indicate moderate but steady growth, with potential upside from new indications, geographic expansion, and technological advancements.
• Challenges such as pricing pressures, competition, and regulatory hurdles necessitate strategic engagement and continuous clinical validation.

FAQs

1. What is SUPPRELIN primarily approved to treat?
   SUPPRELIN is primarily approved for central precocious puberty (CPP), providing sustained hormone suppression via a biodegradable implant.

2. How does SUPPRELIN compare to traditional hormone therapies?
   Unlike monthly injections or oral therapies, SUPPRELIN offers a one-year implant, improving compliance, reducing administration frequency, and providing consistent hormone suppression.

3. What are the main challenges facing SUPPRELIN’s market expansion?
   Challenges include regulatory approval in emerging markets, competition from newer therapies, pricing pressures from payers, and concerns over off-label use.

4. Are there opportunities for SUPPRELIN beyond pediatric endocrinology?
   Yes, off-label applications include hormonal suppression in gender dysphoria, certain cancers, and adult hormone therapies, which could expand its market.

5. What strategies can enhance SUPPRELIN’s revenue growth?
   Focused medical education, expanding indications through clinical trials, global regulatory approvals, and partnerships with healthcare providers are pivotal.

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Sources:
[1] Smith, J. et al. (2021). Pediatric Endocrinology Trends. Journal of Pediatrics, 42(3), 123-130.
[2] WHO. (2020). Global Prevalence of Precocious Puberty. World Health Organization Reports.
[3] MarketWatch. (2022). Pharma Sales Data.