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Last Updated: December 22, 2024

OCTREOTIDE ACETATE Drug Patent Profile


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Which patents cover Octreotide Acetate, and what generic alternatives are available?

Octreotide Acetate is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Heritage, Meitheal, Sagent Pharms Inc, Shuangcheng, Sun Pharm Inds, Teva Pharms Usa Inc, West-ward Pharms Int, Wockhardt Usa, and Mylan Institutional. and is included in twenty-two NDAs.

The generic ingredient in OCTREOTIDE ACETATE 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

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

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Drug patent expirations by year for OCTREOTIDE ACETATE
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Recent Clinical Trials for OCTREOTIDE ACETATE

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

SponsorPhase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 1
Columbia UniversityPhase 1
Albert Einstein College of MedicinePhase 1

See all OCTREOTIDE ACETATE clinical trials

Pharmacology for OCTREOTIDE ACETATE
Medical Subject Heading (MeSH) Categories for OCTREOTIDE ACETATE
Paragraph IV (Patent) Challenges for OCTREOTIDE ACETATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MYCAPSSA Delayed-release Capsules octreotide acetate 20 mg 208232 1 2023-12-29
SANDOSTATIN Injection octreotide acetate 0.05 mg/mL (base), 0.1 mg/mL (base) and 0.5 mg/mL (base) packaged in 1 mL pre-filled syringes (preservative-free) 019667 1 2008-01-17

US Patents and Regulatory Information for OCTREOTIDE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Institutional OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 079198-002 Feb 10, 2011 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa Inc OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 210317-003 Dec 5, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt Usa OCTREOTIDE ACETATE PRESERVATIVE FREE octreotide acetate INJECTABLE;INJECTION 090985-001 May 11, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sagent Pharms Inc OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 090834-003 Nov 12, 2013 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt Usa OCTREOTIDE ACETATE PRESERVATIVE FREE octreotide acetate INJECTABLE;INJECTION 090985-002 May 11, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 077331-001 Mar 4, 2008 DISCN 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 Market Analysis and Financial Projection Experimental

Octreotide Acetate Market Dynamics and Financial Trajectory

Market Overview

The octreotide acetate market is experiencing significant growth, driven by the increasing prevalence of endocrine and neuroendocrine disorders. Octreotide, a synthetic analog of the hormone somatostatin, is crucial in managing conditions such as acromegaly, carcinoid syndrome, and other neuroendocrine tumors (NETs)[3][4].

Market Size and Forecast

As of 2023, the global octreotide acetate market was valued at approximately USD 3.08 billion and is projected to reach USD 3.81 billion by 2031, growing at a compound annual growth rate (CAGR) of 3.1% during the forecast period from 2024 to 2031[1].

Another forecast indicates that the global octreotide market was valued at USD 2.1 billion in 2023 and is anticipated to reach USD 3.4 billion by 2033, growing at a CAGR of 4.9% from 2024 to 2033[3].

Geographic Segmentation

The octreotide acetate market is segmented geographically into North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

  • North America: This region holds a significant share of the market due to advanced healthcare systems, high prevalence of neuroendocrine tumors, and robust research funding. The United States and Canada are key contributors, with strong adoption of octreotide in treatments and clinical settings[1][4].
  • Europe: The market in Europe is driven by high incidences of endocrine disorders and supportive governmental health policies. Major countries such as the United Kingdom, Germany, and France demonstrate increasing investments in healthcare[1].
  • Asia-Pacific: This region is the fastest-growing market, driven by increasing healthcare expenditures, rising chronic disease rates, and an expanding patient pool. Countries like China, India, and Japan are emerging as significant markets due to their large populations and improving healthcare infrastructure[1][3][4].
  • Middle East and Africa: Market growth in this region faces challenges such as limited healthcare access and varying regulatory environments. However, there is an increasing focus on improving healthcare services that could boost the segment[1].
  • Latin America: This region represents a smaller market share but shows potential growth driven by increasing healthcare reforms and awareness about treatments for rare diseases[1].

Key Players

The major players in the octreotide acetate market include:

  • Novartis AG
  • Sun Pharmaceutical Industries Ltd
  • China National Pharmaceutical Group Corporation
  • Sihuan Pharmaceutical Holdings Group Ltd
  • Shanghai Soho-Yiming Pharmaceuticals Co., Ltd
  • JB Pharma
  • Samarth Life Sciences Pvt. Ltd[1].

Market Dynamics

Drivers of Market Growth

  • Rising Prevalence of Endocrine Disorders: The increasing global burden of diseases like acromegaly and carcinoid tumors is fueling demand for octreotide due to its efficacy in symptom management[3][4].
  • Innovations in Drug Formulations: The development and approval of novel octreotide formulations, including long-acting and extended-release products, offer more effective and convenient treatment options, improving patient adherence and outcomes[3][4].
  • Expanding Healthcare Infrastructure: Emerging economies, particularly in the Asia-Pacific region, are enhancing their healthcare capabilities, increasing access to specialty drugs like octreotide[3][4].

Market Restraints

  • High Costs: The high costs associated with octreotide therapies impact affordability, especially in low-income regions, creating barriers to access for some patients[4].
  • Regulatory Challenges: Stringent clinical trial requirements can delay the entry of new formulations, impacting growth. Potential side effects, such as gastrointestinal disturbances and metabolic alterations, can also deter usage[4].

Cost-Effectiveness

Octreotide acetate has been shown to be cost-effective in treating certain conditions. For instance, using octreotide in treating carcinoid tumors and VIPoma was associated with doubled survival time and was found to be cost-effective, with costs of $752 per additional year of life for carcinoid tumors[2].

Future Outlook

The global octreotide acetate market is expected to continue its growth trajectory, driven by the rising prevalence of acromegaly and neuroendocrine tumors, the increasing demand for effective and safe treatments, and the ongoing advancements in drug development and delivery technologies. The Asia-Pacific region is anticipated to be the fastest-growing market, with countries like China and India leading the way[3][4].

Technological Advancements

Technological innovations in drug delivery systems, such as subcutaneous and sustained-release formulations, implantable devices, and transdermal patches, are enhancing patient convenience and adherence to treatment. These advancements are expected to further drive market growth and improve patient outcomes[3][4].

Market Opportunities

  • Expanding Therapeutic Applications: Research into octreotide’s efficacy in treating additional conditions, such as certain gastrointestinal and liver disorders, presents new market avenues[4].
  • Emerging Economies: Increasing healthcare spending and infrastructure investments in emerging economies are likely to boost demand for octreotide[4].
  • Digital Health Integration: Pharmaceutical companies are exploring partnerships with digital health providers to integrate monitoring technologies that optimize dosage and improve patient outcomes, underscoring the market's potential for growth[4].

Key Takeaways

  • The octreotide acetate market is projected to grow significantly, driven by the increasing prevalence of endocrine and neuroendocrine disorders.
  • North America and Europe are currently leading the market, but the Asia-Pacific region is expected to be the fastest-growing segment.
  • Innovations in drug formulations and expanding healthcare infrastructure are key drivers of market growth.
  • High costs and regulatory challenges are significant restraints to market growth.
  • The market is expected to continue growing, driven by advancements in drug delivery technologies and increasing demand for effective treatments.

Frequently Asked Questions

What is the current market size of the octreotide acetate market?

The global octreotide acetate market was valued at approximately USD 3.08 billion in 2023[1].

What is the projected growth rate of the octreotide acetate market?

The market is projected to grow at a CAGR of 3.1% from 2024 to 2031[1].

Which region is expected to be the fastest-growing market for octreotide acetate?

The Asia-Pacific region is anticipated to be the fastest-growing market, driven by increasing healthcare expenditures and rising chronic disease rates[1][3][4].

What are the key drivers of growth in the octreotide acetate market?

The key drivers include the rising prevalence of endocrine and neuroendocrine disorders, innovations in drug formulations, and expanding healthcare infrastructure in emerging economies[3][4].

What are the major restraints to the growth of the octreotide acetate market?

The major restraints include high costs associated with octreotide therapies, regulatory challenges, and potential side effects[4].

Cited Sources

  1. Verified Market Research - Octreotide Acetate Market Size, Share, Scope, Trends & Forecast[1].
  2. PubMed - The cost-effectiveness of octreotide acetate in the treatment of carcinoid syndrome and VIPoma[2].
  3. Data Horizon Research - Octreotide Market Size, Share & Forecast 2033[3].
  4. Global Growth Insights - Octreotide Market Share, Forecast [2032][4].
  5. DrugBank Online - Octreotide: Uses, Interactions, Mechanism of Action[5].

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