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Last Updated: December 23, 2024

SOMATULINE Drug Patent Profile


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

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

The generic ingredient in SOMATULINE 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

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

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Summary for SOMATULINE
US Patents:0
Applicants:1
NDAs:1
Drug Prices: Drug price information for SOMATULINE
DailyMed Link:SOMATULINE at DailyMed
Drug patent expirations by year for SOMATULINE
Drug Prices for SOMATULINE

See drug prices for SOMATULINE

US Patents and Regulatory Information for SOMATULINE

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

SOMATULINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SOMATULINE

Market Overview

The SOMATULINE market, which falls under the broader category of somatostatin analogs, is experiencing significant growth driven by several key factors.

Increasing Incidence of Hormonal Disorders

The rising incidence of diseases such as acromegaly and neuroendocrine tumors (NETs) is a primary driver of the SOMATULINE market. These conditions require effective treatments to manage hormone overproduction, and SOMATULINE, with its extended-release formulations, is highly appealing to both patients and healthcare professionals[1][3][4].

Regional Market Performance

North America

North America dominates the SOMATULINE market, accounting for around 40% of the global revenue. This dominance is attributed to the region's advanced healthcare infrastructure, high R&D investments, and favorable reimbursement policies. The prevalence of acromegaly and NETs, along with the aging population, further fuels the demand for SOMATULINE in this region[1][3].

Europe

Europe holds a substantial share of the market, driven by a comprehensive healthcare system, significant investment in medical research, and a strong pharmaceutical industry. The region's regulatory support for orphan drugs and rare disease treatments also contributes to market growth[3].

Asia Pacific

The Asia Pacific region is witnessing rapid growth, driven by increasing healthcare expenditure, rising awareness of neuroendocrine disorders, and improving access to advanced treatments. The growing middle class and expanding healthcare infrastructure in this region present significant growth opportunities for SOMATULINE[1][3][4].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa regions are also experiencing growth, albeit at a slower pace. The market expansion in these regions is driven by increasing awareness of hormonal disorders and better access to healthcare services, although economic constraints and lower healthcare spending limit the growth rate[1][3].

Financial Trajectory

Market Size and Growth Rate

The global SOMATULINE market is projected to grow at a compound annual growth rate (CAGR) of 4.20% from 2024 to 2031. The market size in 2024 is estimated to be in the millions of USD and is expected to expand significantly over the forecast period[1].

Revenue Distribution

  • North America: Expected to grow at a CAGR of 2.4% from 2024 to 2031, with a market size that accounts for more than 40% of the global revenue[1].
  • Asia Pacific: Growing at a CAGR of 6.2% from 2024 to 2031, with a market share of around 23% of the global revenue[1].
  • Latin America: Expected to grow at a CAGR of 3.6% from 2024 to 2031, with a market share of more than 5% of the global revenue[1].
  • Middle East & Africa: Growing at a CAGR of 3.9% from 2024 to 2031, with a market share of around 2% of the global revenue[1].

Global Somatostatin Analogs Market Context

The broader somatostatin analogs market, which includes SOMATULINE, is forecasted to reach approximately USD 11.4 billion by 2033, growing at a CAGR of 6.1% from 2024 to 2033. This growth is driven by technological advancements, expanding therapeutic applications, and increasing healthcare investments[3].

Key Drivers of Market Growth

Technological Advancements and Innovation

Advancements in biotechnology and the development of new drug delivery systems are crucial for the growth of the SOMATULINE market. Innovations in healthcare technology and global health initiatives are shaping the market prospects, with landmark FDA approvals and strategic mergers and acquisitions highlighting the competitive landscape[3][4].

Increasing Awareness and Diagnostic Capabilities

Rising awareness among healthcare professionals and patients about the benefits of somatostatin analogs, including SOMATULINE, is driving higher adoption rates. Improved diagnostic tools and changing treatment protocols also contribute to the market's expansion[1][3].

Expanding Healthcare Infrastructure

The growth in healthcare infrastructure, particularly in emerging markets, is a significant factor. Better access to advanced treatments and increasing healthcare spending in regions like Asia Pacific and Latin America are fueling the demand for SOMATULINE[1][3][4].

Patient Assistance Programs

Patient assistance programs, such as the SOMATULINE DEPOT Patient Assistance Program (PAP), provide financial support to eligible patients, making the drug more accessible and contributing to market growth. These programs help patients who are experiencing financial hardship and have no insurance coverage[2].

Challenges and Limitations

Economic Constraints

Economic constraints and lower healthcare spending in regions like the Middle East & Africa limit the market expansion. Despite these challenges, ongoing investments in healthcare development are expected to enhance market performance gradually[1][3].

Regulatory and Reimbursement Issues

The market is also influenced by regulatory frameworks and reimbursement policies. While favorable policies in regions like North America support market growth, variations in these policies across different regions can pose challenges[3][5].

Key Takeaways

  • Market Growth: The SOMATULINE market is expected to grow at a CAGR of 4.20% from 2024 to 2031.
  • Regional Dominance: North America dominates the market, followed by Europe and Asia Pacific.
  • Drivers: Technological advancements, increasing awareness, and expanding healthcare infrastructure are key drivers.
  • Challenges: Economic constraints and regulatory variations pose challenges to market growth.
  • Patient Support: Patient assistance programs play a crucial role in making SOMATULINE more accessible.

FAQs

What are the primary drivers of the SOMATULINE market?

The primary drivers include the rising incidence of acromegaly and neuroendocrine tumors, technological advancements, increasing awareness among healthcare professionals and patients, and expanding healthcare infrastructure.

Which region dominates the SOMATULINE market?

North America dominates the SOMATULINE market, accounting for around 40% of the global revenue.

What is the expected CAGR of the SOMATULINE market from 2024 to 2031?

The SOMATULINE market is expected to grow at a CAGR of 4.20% from 2024 to 2031.

How do patient assistance programs impact the SOMATULINE market?

Patient assistance programs, such as the SOMATULINE DEPOT PAP, make the drug more accessible to patients experiencing financial hardship, thereby contributing to market growth.

What are the challenges faced by the SOMATULINE market in emerging regions?

Economic constraints and lower healthcare spending are significant challenges in regions like the Middle East & Africa, although ongoing investments in healthcare development are expected to enhance market performance.

Sources

  1. Cognitive Market Research: Somatuline Drugs market report.
  2. RxHope: SOMATULINE DEPOT Patient Assistance Program (PAP) application.
  3. MarketResearch.biz: Somatostatin Analogs Market Size, Share, Growth.
  4. GlobeNewswire: Global Somatostatin Analogs Market to Reach $8.67 Billion by 2028.
  5. Somatuline Depot: Reimbursement Resource Guide.

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