LANREOTIDE ACETATE - Generic Drug Details

What are the generic sources for lanreotide acetate and what is the scope of patent protection?

Lanreotide acetate is the generic ingredient in two branded drugs marketed by Invagen Pharms and Ipsen Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for lanreotide acetate. Three suppliers are listed for this compound.

Summary for LANREOTIDE ACETATE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	4
Patent Applications:	5,679
What excipients (inactive ingredients) are in LANREOTIDE ACETATE?	LANREOTIDE ACETATE excipients list
DailyMed Link:	LANREOTIDE ACETATE at DailyMed

Recent Clinical Trials for LANREOTIDE ACETATE

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

Sponsor	Phase
Debiopharm International SA	Phase 1
Ipsen	Phase 1/Phase 2
Ipsen	Phase 3

See all LANREOTIDE ACETATE clinical trials

Pharmacology for LANREOTIDE ACETATE

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for LANREOTIDE ACETATE

H01CB	Somatostatin and analogues
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for LANREOTIDE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	215395-002	Dec 17, 2021		RX	Yes	Yes
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	217193-003	May 21, 2024	AB	RX	No	No
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	217193-001	May 21, 2024	AB	RX	No	No
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	022074-003	Aug 30, 2007	AB	RX	Yes	Yes
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	217193-002	May 21, 2024	AB	RX	No	No
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	215395-003	Dec 17, 2021		RX	Yes	Yes

Expired US Patents for LANREOTIDE ACETATE

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	5,595,760
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-003	Aug 30, 2007	5,595,760
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-002	Aug 30, 2007	5,595,760

LANREOTIDE ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lanreotide Acetate

Introduction

Lanreotide acetate, a somatostatin analogue, has been a significant player in the treatment of various endocrine disorders, including acromegaly and neuroendocrine tumors. The market for lanreotide acetate has experienced substantial growth and is projected to continue on this upward trajectory.

Market Size and Growth Projections

The lanreotide acetate market was valued at USD 1.2 billion in 2023 and is expected to reach USD 2.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.2% from 2024 to 2031[4].

Segmentation and Key Markets

The market is segmented based on several factors:

• Application: The primary applications include the treatment of acromegaly, neuroendocrine tumors, and pituitary disorders[4].
• Product Formulations: Lanreotide is available in various forms such as injections, capsules, and extended-release formulations[4].
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][3][4].

Drivers of Market Growth

Several factors are driving the growth of the lanreotide acetate market:

• Efficacy in Treatment: Lanreotide's proven efficacy in managing neuroendocrine tumors and acromegaly has led to increased prescriptions and usage[4].
• Advances in Drug Formulations: Improvements in drug delivery systems and formulation enhancements have improved patient compliance and treatment outcomes[4].
• Increasing Awareness and Diagnosis: Growing awareness and early diagnosis of endocrine disorders, coupled with expanding healthcare access and infrastructure, support market growth[4].
• Ongoing Clinical Research: Continuous research into new indications and the expansion of lanreotide’s availability in emerging markets further fuel its demand[4].

Cost-Effectiveness and Pricing

The cost-effectiveness of lanreotide acetate is a critical factor in its market dynamics:

• Comparison with Octreotide LAR: Studies have shown that octreotide long-acting release (LAR) is associated with lower costs compared to lanreotide over various time horizons. For instance, over a 5-year horizon, octreotide LAR costs were $37,323 lower than lanreotide[5].
• Cost-Effectiveness Analysis: A cost-effectiveness analysis indicated that upfront lanreotide treatment for metastatic enteropancreatic neuroendocrine tumors is not cost-effective at its current price. It would need a significant price reduction to reach acceptable incremental cost-effectiveness ratios (ICERs) of $100,000/QALY or $150,000/QALY[2].

Financial Implications

The financial implications of lanreotide acetate treatment are substantial:

• Treatment Costs: The cost of upfront lanreotide treatment can be as high as $804,600, while active surveillance followed by lanreotide after progression costs around $590,200[2].
• Payer Costs: The costs to payers for treating gastrointestinal neuroendocrine tumors with lanreotide over a 5-year period can be approximately $299,667, which is higher than the costs associated with octreotide LAR[5].

Market Opportunities and Challenges

• Market Opportunities: The expanding healthcare infrastructure, increasing awareness of endocrine disorders, and ongoing research into new indications present significant opportunities for market growth[4].
• Market Challenges: High treatment costs, competition from other somatostatin analogues like octreotide LAR, and the need for cost-effectiveness adjustments are key challenges facing the lanreotide acetate market[2][5].

Geographical Market Analysis

The market for lanreotide acetate varies significantly across different geographical regions:

• North America and Europe: These regions are expected to remain major markets due to advanced healthcare systems and higher awareness of endocrine disorders[1][3][4].
• Asia-Pacific: This region is anticipated to show significant growth due to expanding healthcare access and increasing diagnosis rates[1][3][4].

Key Players and Competitive Landscape

The lanreotide acetate market is dominated by several key players:

• Ipsen: As the primary manufacturer of Somatuline Depot (lanreotide), Ipsen plays a crucial role in the market[3][4].
• Other Players: Companies like Novartis, Pfizer, AbbVie, AstraZeneca, Eli Lilly, Merck, Roche, Teva, and Sanofi also influence the market through their presence in related therapeutic areas[4].

Future Outlook

The future outlook for the lanreotide acetate market is positive, driven by:

• Continued Research: Ongoing clinical research into new indications and formulations will likely expand the market[4].
• Expanding Healthcare Access: Growing healthcare infrastructure and access in emerging markets will increase demand for lanreotide acetate[4].

Key Takeaways

• The lanreotide acetate market is projected to grow significantly from 2023 to 2031.
• The market is driven by the drug's efficacy, advances in formulations, and increasing awareness of endocrine disorders.
• Cost-effectiveness remains a challenge, with potential need for price adjustments to make upfront treatment more viable.
• Geographical regions like North America, Europe, and Asia-Pacific are key markets.
• Ipsen and other major pharmaceutical companies play significant roles in the market.

FAQs

Q: What is the current market size of the lanreotide acetate market? A: The lanreotide acetate market was valued at USD 1.2 billion in 2023[4].

Q: What is the projected growth rate of the lanreotide acetate market from 2024 to 2031? A: The market is expected to grow at a CAGR of 7.2% from 2024 to 2031[4].

Q: Which regions are expected to be major markets for lanreotide acetate? A: North America, Europe, and Asia-Pacific are anticipated to be significant markets[1][3][4].

Q: How does the cost of lanreotide compare to octreotide LAR? A: Lanreotide is generally more expensive than octreotide LAR over various treatment horizons[5].

Q: What are the primary drivers of the lanreotide acetate market growth? A: The market growth is driven by the drug's efficacy, advances in drug formulations, increasing awareness and diagnosis of endocrine disorders, and ongoing clinical research[4].

Cited Sources

1. Market Research Intellect, "Global Lanreotide Acetate Market Size, Scope And Forecast Report".
2. JNCCN, "Cost-Effectiveness of Initial Versus Delayed Lanreotide for Patients With Metastatic Enteropancreatic Neuroendocrine Tumors".
3. Market Research Intellect, "Lanreotide Drugs Market Size And Forecast".
4. Market Research Intellect, "Lanreotide Market Size, Overview & Research Report [2024-2031]".
5. Analysis Group, "Comparing the cost of treatment with octreotide long-acting release versus lanreotide in patients with metastatic gastrointestinal neuroendocrine tumors".