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Last Updated: December 22, 2024

OCTREOTIDE ACETATE (PRESERVATIVE FREE) Drug Patent Profile


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When do Octreotide Acetate (preservative Free) patents expire, and what generic alternatives are available?

Octreotide Acetate (preservative Free) is a drug marketed by Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms Inc, and West-ward Pharms Int. and is included in four NDAs.

The generic ingredient in OCTREOTIDE ACETATE (PRESERVATIVE FREE) is octreotide acetate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Octreotide Acetate (preservative Free)

A generic version of OCTREOTIDE ACETATE (PRESERVATIVE FREE) was approved as octreotide acetate by WEST-WARD PHARMS INT on April 8th, 2005.

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Summary for OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Drug patent expirations by year for OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Pharmacology for OCTREOTIDE ACETATE (PRESERVATIVE FREE)

US Patents and Regulatory Information for OCTREOTIDE ACETATE (PRESERVATIVE FREE)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 077457-001 Feb 10, 2006 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sagent Pharms Inc OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 090834-001 Nov 12, 2013 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Institutional OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 079198-001 Feb 10, 2011 AP RX No No ⤷  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

OCTREOTIDE ACETATE (PRESERVATIVE FREE) Market Analysis and Financial Projection Experimental

Octreotide Acetate (Preservative Free): Market Dynamics and Financial Trajectory

Introduction to Octreotide Acetate

Octreotide acetate is a synthetic somatostatin analog used primarily to treat conditions such as acromegaly, severe diarrhea associated with carcinoid syndrome, and other neuroendocrine tumors. Its effectiveness in managing hormone-related symptoms has made it a crucial drug in the therapeutic landscape.

Market Size and Growth

The octreotide market has been experiencing significant growth over recent years. As of 2023, the global octreotide market was valued at approximately USD 2.2 billion and is projected to reach USD 3.6 billion by 2032, with a compound annual growth rate (CAGR) of 5.38% from 2024 to 2032[3].

Drivers of Market Growth

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

Rising Prevalence of Endocrine Disorders

The increasing global burden of diseases such as acromegaly and carcinoid tumors is fueling the demand for octreotide. Aging populations, particularly in North America and Europe, are contributing to this trend[3].

Advancements in Drug Formulations

Innovations in long-acting octreotide injectables and digital adherence tools have enhanced patient compliance and expanded the drug's therapeutic applications. These advancements make treatment more accessible and manageable, improving patient outcomes[3].

Expanding Healthcare Infrastructure

Emerging economies, especially in the Asia-Pacific region, are investing heavily in healthcare infrastructure. This expansion is increasing access to specialty drugs like octreotide, driving market penetration[3].

Market Opportunities

The octreotide acetate market presents several opportunities for growth:

Expanding Therapeutic Applications

Research into octreotide's efficacy in treating additional conditions, such as certain gastrointestinal and liver disorders, offers new market avenues. This potential expansion could significantly boost the market size[3].

Technological Innovations

Technological advancements in drug delivery systems, including implantable devices and transdermal patches, are expected to enhance patient adherence and comfort. Partnerships between pharmaceutical companies and digital health providers to integrate monitoring technologies also hold promise for market growth[3].

Emerging Markets

Emerging economies represent untapped markets where increasing healthcare spending and infrastructure investments are likely to boost demand for octreotide. Government policies prioritizing access to essential drugs further stimulate market growth in these regions[3].

Market Restraints and Challenges

Despite the growth potential, the octreotide acetate market faces several challenges:

High Costs of Treatment

The high costs associated with octreotide therapies are a significant barrier, particularly in low-income regions. This affordability issue limits market access and growth[3][4].

Regulatory Challenges

Stringent clinical trial requirements and regulatory hurdles can delay the entry of new formulations into the market, impacting growth. Additionally, potential side effects such as gastrointestinal disturbances and metabolic alterations can deter usage, especially in patients requiring long-term therapy[3].

Financial Performance and Projections

Current Market Value

As of 2023, the octreotide market was valued at USD 2.2 billion. By 2024, this value is expected to increase to USD 2.341 billion, and by 2032, it is projected to reach USD 3.6 billion[3].

Annual Sales

The generic version of Sandostatin LAR Depot, launched by Teva, had annual sales of $826 million as of July 2024, indicating the significant financial potential of octreotide acetate in the market[2].

CAGR and Growth Rate

The market is expected to grow at a CAGR of 5.38% from 2024 to 2032. This growth rate underscores the robust expansion anticipated in the coming years[3].

Regional Analysis

North America

North America dominates the octreotide market due to the presence of key manufacturers and high research and development activities. The region's advanced healthcare infrastructure and high prevalence of endocrine disorders further drive market growth[4].

Asia-Pacific

The Asia-Pacific region is witnessing positive growth due to increased research and development activities and expanding healthcare infrastructure. This region is expected to be a significant contributor to the market's future growth[4].

Key Players and Market Competition

The market is characterized by the presence of major pharmaceutical companies, including Teva, which recently launched the first generic version of Sandostatin LAR Depot. The competition is driven by the ability to bring complex generic formulations to market and the focus on sustaining a generics powerhouse[2].

Conclusion

The octreotide acetate market is poised for significant growth driven by increasing demand for advanced therapeutic treatments, innovations in drug formulations, and expanding healthcare infrastructure in emerging economies. Despite challenges such as high treatment costs and regulatory hurdles, the market's financial trajectory indicates robust expansion, with a projected CAGR of 5.38% from 2024 to 2032.

Key Takeaways

  • The global octreotide market is valued at USD 2.2 billion in 2023 and is expected to reach USD 3.6 billion by 2032.
  • The market is driven by the rising prevalence of endocrine disorders, advancements in drug formulations, and expanding healthcare infrastructure.
  • High treatment costs and regulatory challenges are significant restraints.
  • North America and the Asia-Pacific region are key markets due to their advanced healthcare infrastructure and growing demand.
  • Technological innovations and expanding therapeutic applications offer substantial growth opportunities.

FAQs

What is Octreotide Acetate Used For?

Octreotide acetate is used to treat conditions such as acromegaly and severe diarrhea associated with carcinoid syndrome. It is also effective in managing hormone-related symptoms in neuroendocrine tumors[2][5].

What is the Projected Growth Rate of the Octreotide Market?

The octreotide market is expected to grow at a CAGR of 5.38% from 2024 to 2032[3].

What are the Key Drivers of the Octreotide Market?

Key drivers include the rising prevalence of endocrine disorders, advancements in drug formulations, and expanding healthcare infrastructure in emerging economies[3].

What are the Major Challenges Facing the Octreotide Market?

Major challenges include the high costs associated with treatment, regulatory hurdles, and potential side effects such as gastrointestinal disturbances and metabolic alterations[3][4].

Which Regions are Expected to Drive the Growth of the Octreotide Market?

North America and the Asia-Pacific region are expected to be significant contributors to the market's growth due to their advanced healthcare infrastructure and growing demand[4].

Cited Sources:

  1. Market Research Intellect - Octreotide Acetate Sales Market Size, Scope And Forecast Report
  2. Teva USA - Teva Announces Launch of the First and Only Generic Version of Sandostatin LAR Depot
  3. Global Growth Insights - Octreotide Market Share, Forecast [2032]
  4. Data Bridge Market Research - Global Octreotide Market – Industry Trends and Forecast to 2030
  5. Fresenius Kabi USA - OCTREOTIDE ACETATE Injection[5]

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