SOMATULINE DEPOT Drug Patent Profile

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

Somatuline Depot is a drug marketed by Ipsen Pharma and is included in one NDA.

The generic ingredient in SOMATULINE DEPOT is lanreotide acetate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanreotide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Somatuline Depot

A generic version of SOMATULINE DEPOT was approved as lanreotide acetate by INVAGEN PHARMS on December 17^th, 2021.

Summary for SOMATULINE DEPOT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	27
Patent Applications:	694
What excipients (inactive ingredients) are in SOMATULINE DEPOT?	SOMATULINE DEPOT excipients list
DailyMed Link:	SOMATULINE DEPOT at DailyMed

Recent Clinical Trials for SOMATULINE DEPOT

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

Sponsor	Phase
University Hospital, Antwerp	Phase 4
Belgium Health Care Knowledge Centre	Phase 4
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 4

See all SOMATULINE DEPOT clinical trials

Pharmacology for SOMATULINE DEPOT

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

US Patents and Regulatory Information for SOMATULINE DEPOT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-001	Aug 30, 2007	AB	RX	Yes	Yes
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-002	Aug 30, 2007	AB	RX	Yes	Yes
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-003	Aug 30, 2007	AB	RX	Yes	Yes

Expired US Patents for SOMATULINE DEPOT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-001	Aug 30, 2007
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-003	Aug 30, 2007
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-002	Aug 30, 2007

International Patents for SOMATULINE DEPOT

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0953362
South Africa	9601904
Austria	346628
China	1165479
Japan	H10508293
Germany	69534538
Austria	210424

Supplementary Protection Certificates for SOMATULINE DEPOT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0779805	91037	Luxembourg		91037, EXPIRES: 20160511
0779805	CA 2002 00032	Denmark

Market Dynamics and Financial Trajectory for SOMATULINE DEPOT

Last updated: July 27, 2025

Introduction

SOMATULINE DEPOT (octreotide acetate) is a long-acting somatostatin analog primarily indicated for managing acromegaly, carcinoid tumors, and symptomatic control of vasoactive intestinal peptide-secreting tumors (VIPomas). Since its FDA approval in 2000, it has maintained a significant footprint within endocrinology and neuroendocrinology markets. The drug's market dynamics hinge on the evolving landscape of neuroendocrine tumor management, advances in treatment options, and regulatory developments. Analyzing its financial trajectory offers insights into growth prospects, market penetration, and competitive positioning.

Market Landscape and Key Drivers

Therapeutic Demand and Market Segments

The global neuroendocrine tumor (NET) treatment market, encompassing conditions treated by SOMATULINE DEPOT, is projected to grow at a compound annual growth rate (CAGR) of approximately 7-8% through 2028[1]. SOMATULINE DEPOT addresses a niche but high-value segment—patients with acromegaly and functioning neuroendocrine tumors—driving steady demand due to the chronic nature of these conditions.

Increasing Prevalence of Target Conditions

Globally, the prevalence of acromegaly is estimated at approximately 60-70 cases per million, with diagnosis often delayed, leading to prolonged treatment periods[2]. Similarly, carcinoid tumors, a subset of NETs, are rising in incidence, partly due to improved diagnostic imaging techniques. This rising prevalence fuels demand for long-term, effective therapies like SOMATULINE DEPOT.

Advancements in Diagnostic Technologies

Emerging imaging modalities, such as Gallium-68 PET scans, improve tumor detection and monitoring accuracy, fostering early intervention and prescription of long-acting agents like SOMATULINE DEPOT. Enhanced diagnostic capabilities bolster patient identification and treatment adherence, underpinning the drug's continued relevance in therapeutic regimens.

Competitive and Regulatory Factors

While SOMATULINE DEPOT holds a dominant position, the market faces challenges from alternative somatostatin analogs like lanreotide (Somatuline) and biosimilars entering the market. Regulatory policies and patent protections significantly influence market dynamics; patent expiration timelines, such as the one expected in 2027 for certain formulations, may open doors for biosimilar entrants impacting future revenue streams.

Market Competition and Pricing Dynamics

Branded Versus Biosimilar Competition

The landscape is increasingly contested by biosimilars aiming to offer more affordable options. The introduction of biosimilars typically prompts price erosion; however, the high switching costs and physician loyalty slow immediate market penetration[3]. As patent protections diminish, market share shifts could significantly affect SOMATULINE DEPOT's revenues.

Pricing Strategies

Pricing remains a critical determinant of market share and profitability. In North America, prices for long-acting somatostatin analogs can range from $30,000 – $40,000 per patient annually[4]. Manufacturer strategies involving value-based pricing, patient assistance programs, and collaborations with insurers optimize revenue and patient access.

Reimbursement and Payer Policies

Reimbursement landscapes, particularly in the US and European markets, influence utilization rates. Insurance providers tend to favor cost-effective therapies; thus, evidence demonstrating superior efficacy, safety, and durability justifies premium pricing for SOMATULINE DEPOT. Cost-effectiveness analyses positioned favorably support continued formulary inclusion.

Regulatory and Patent Outlook

Regulatory Approvals and Indications

SOMATULINE DEPOT holds multiple indications: acromegaly, carcinoid syndrome, and VIPomas—expanding its therapeutic scope. Approval processes for new indications and formulations can augment market size. Recent approvals for extended-release formulations in various jurisdictions could further enhance drug positioning.

Patent Expiry and Biosimilar Entry

Key patents for SOMATULINE DEPOT are expected to expire around 2027, opening the market to biosimilars and generics. Although biosimilar entry could intensify price competition, it may take several years for biosimilars to achieve significant market penetration due to clinical and regulatory hurdles.

Regulatory Incentives

Accelerated approval pathways, breakthrough device designations, and orphan drug status in certain jurisdictions facilitate market expansion and product development, bolstering revenue streams.

Financial Trajectory Analysis

Historical Performance

SOMATULINE DEPOT has demonstrated steady revenue growth over the past decade, driven by increased prevalence, improved diagnosis, and expanded indications. Financial reports indicate gross revenues exceeding $1 billion annually in leading markets, with margins maintained through optimized manufacturing and supply chain efficiencies[5].

Forecasted Growth and Revenue Trends

Projections suggest that by 2028, SOMATULINE DEPOT could sustain a CAGR of 4-6%, factoring in:

• Market Expansion: Untapped regions and extended indications.
• Patent Cliff and Biosimilar Competition: Potential revenue contraction post-2027.
• Pricing Strategies: Continued negotiations for favorable reimbursement.
• Clinical Trials and New Data: Demonstrating broader efficacy or enhanced formulations.

The introduction of durable formulations and combination therapies may further expand revenue streams. However, price erosion from biosimilar competitors remains the primary risk to sustained growth.

Investment Considerations

Pharmaceutical companies holding patents or licensure rights anticipate revenue stabilization initially, followed by strategic growth through R&D, market penetration, and indications expansion. Investment analyses recommend monitoring biosimilar developments and regulatory milestones to assess long-term financial prospects.

Emerging Trends and Future Outlook

Personalized Medicine and Combination Therapy

Advances in genetic profiling and biomarker identification will enable tailored therapies, potentially increasing SOMATULINE DEPOT's applicability in composite treatment strategies. Combination therapies targeting multiple pathways could boost efficacy and demand.

Digital Health Integration

Remote monitoring and adherence tools could optimize long-term management of neuroendocrine tumors, improving treatment outcomes and fostering more consistent SOMATULINE DEPOT utilization.

Global Market Penetration

Emerging markets, with increasing healthcare infrastructure and rising disease prevalence, present substantial growth opportunities. Affordability strategies and local manufacturing can catalyze market expansion.

Key Takeaways

• Steady Demand with Growth Potential: The global NE tumor treatment market supports ongoing demand for SOMATULINE DEPOT, driven by increasing disease prevalence and improved diagnostics.
• Competitive Landscape Risks: Patent expiries and biosimilar entries pose short- to medium-term threats; strategic pricing and indication expansion mitigate these risks.
• Financial Outlook: Long-term revenues are expected to grow modestly (4-6% CAGR), with potential acceleration through new formulations, indications, and regional expansion.
• Regulatory and Patent Dynamics: Close monitoring of patent expiry timelines and regulatory approvals will be crucial for revenue forecasts.
• Innovation and Digital Health: Incorporation of personalized medicine and digital tools could sustain competitive advantage and foster future growth.

FAQs

1. When is the patent expiry for SOMATULINE DEPOT, and how does this impact the market?
The primary patents for SOMATULINE DEPOT are expected to expire around 2027. Patent expiry often leads to increased biosimilar competition, exerting downward pressure on prices and potentially reducing market share. However, the timing will influence strategic R&D investments and market preparations.

2. What are the main indications driving sales for SOMATULINE DEPOT?
The main indications are acromegaly, carcinoid syndrome, and VIPomas. These chronic conditions necessitate long-term management, ensuring consistent demand for long-acting formulations like SOMATULINE DEPOT.

3. How does biosimilar competition influence the financial trajectory of SOMATULINE DEPOT?
Biosimilars typically offer lower-cost alternatives, reducing overall market prices and margins. Although biosimilar entry may initially be limited due to clinical and regulatory hurdles, their eventual penetration can significantly impact revenues post-patent expiry.

4. Which regions represent the most promising growth opportunities for SOMATULINE DEPOT?
North America and Europe are mature markets with high adoption rates. Emerging markets in Asia-Pacific and Latin America are promising due to increasing disease awareness, improved healthcare infrastructure, and cost considerations.

5. What role does reimbursement policy play in the drug’s financial outlook?
Reimbursement frameworks heavily influence prescribing practices. Favorable policies that include SOMATULINE DEPOT in formularies and provide adequate coverage help sustain or increase sales volumes, whereas restrictive policies could hamper growth.

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Sources:
[1] Reports on neuroendocrine tumor markets, 2023.
[2] Katznelson, L., et al., Endocrine Reviews, 2014.
[3] MarketWatch, Biosimilar Launches, 2022.
[4] Medicare and insurance reimbursement policies, 2023.
[5] Company financial disclosures, 2022.