OCTREOTIDE ACETATE - Generic Drug Details

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

Octreotide acetate is the generic ingredient in seven branded drugs marketed by Chiesi, Fresenius Kabi Usa, Gland, Heritage, Meitheal, Sagent Pharms Inc, Shuangcheng, Sun Pharm Inds, Teva Pharms Usa Inc, West-ward Pharms Int, Wockhardt Usa, Mylan Institutional, Novartis, and Sun Pharm, and is included in twenty-six NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Octreotide acetate has eighty-six patent family members in twenty-nine countries.

There are nineteen drug master file entries for octreotide acetate. Fourteen suppliers are listed for this compound.

Summary for OCTREOTIDE ACETATE

International Patents:	86
US Patents:	21
Tradenames:	7
Applicants:	14
NDAs:	26
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	47
Drug Prices:	Drug price trends for OCTREOTIDE ACETATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OCTREOTIDE ACETATE
What excipients (inactive ingredients) are in OCTREOTIDE ACETATE?	OCTREOTIDE ACETATE excipients list
DailyMed Link:	OCTREOTIDE ACETATE at DailyMed

See drug prices for OCTREOTIDE ACETATE

Recent Clinical Trials for OCTREOTIDE ACETATE

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

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1
Columbia University	Phase 1
Albert Einstein College of Medicine	Phase 1

See all OCTREOTIDE ACETATE clinical trials

Pharmacology for OCTREOTIDE ACETATE

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Medical Subject Heading (MeSH) Categories for OCTREOTIDE ACETATE

Antineoplastic Agents, Hormonal

Gastrointestinal Agents

Anatomical Therapeutic Chemical (ATC) Classes for OCTREOTIDE ACETATE

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

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
Sun Pharm Inds	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	077330-001	Mar 4, 2008		DISCN	No	No
Sun Pharm Inds	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	077373-002	Aug 14, 2007		DISCN	No	No
Teva Pharms Usa Inc	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	210317-001	Dec 5, 2023	AB	RX	No	No

Expired US Patents for OCTREOTIDE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-004	Jun 12, 1991
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-003	Nov 25, 1998
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998

International Patents for OCTREOTIDE ACETATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010032140
Australia	2016215350
New Zealand	591810	PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY THE COMPOSITION COMPRISES A MEDIUM CHAIN FATTY ACID

Market Dynamics and Financial Trajectory for Octreotide Acetate

Last updated: July 27, 2025

Introduction

Octreotide acetate is a synthetic analog of somatostatin, a peptide hormone that modulates endocrine and exocrine functions. Primarily utilized to treat acromegaly, carcinoid tumors, and severe diarrhea associated with vasoactive intestinal peptide-secreting tumors, octreotide has established itself as a critical agent in the oncology and endocrinology spaces. Examining its market dynamics and financial trajectory reveals insights into growth drivers, competitive positioning, regulatory influences, and future opportunities.

Market Overview

The global octreotide acetate market is characterized by steady growth driven by increasing prevalence of target diseases, technological advancements, and expanding global healthcare access. As per recent figures, the market size was valued at approximately USD 850 million in 2022, with projections indicating a compound annual growth rate (CAGR) of around 4-6% over the next five years [1]. The growth is fueled by both innovator and biosimilar products, with an increasing preference for long-acting injectable formulations.

Market Drivers

Rising Disease Prevalence

The escalation in acromegaly and neuroendocrine tumor (NET) cases globally underpins demand for octreotide. Acromegaly, primarily caused by pituitary adenomas, has an estimated prevalence of 60-70 cases per million individuals [2], with many cases remaining undiagnosed or untreated. Neuroendocrine tumors, often diagnosed late, represent a substantial market segment; octreotide’s efficacy in symptom control and tumor suppression positions it as a frontline therapy.

Advances in Drug Formulation

Long-acting formulations such as octreotide LAR (long-acting repeatable) have expanded treatment compliance and improved patient outcomes. These formulations allow administration once a month, reducing treatment burden and enhancing adherence, thereby expanding market penetration.

Growing Healthcare Access

Increasing healthcare infrastructure in emerging markets such as Asia-Pacific and Latin America enhances product availability. Rising healthcare expenditure and awareness contribute to early diagnosis and treatment initiation, positively influencing market growth.

Regulatory Approvals and Pipeline Growth

Regulatory agencies such as the FDA and EMA continue to approve new indications and formulations, expanding octreotide’s therapeutic landscape. Additionally, ongoing clinical trials investigating novel delivery mechanisms and combination therapies suggest potential market expansion.

Market Restraints and Challenges

High Cost of Therapy

Octreotide remains expensive, particularly for patients requiring long-term treatment. Cost barriers lead to limited accessibility in low-income regions, imposing constraints on market expansion.

Generic Competition

The patent expiry of key formulations like Sandostatin® has facilitated entry of biosimilars, intensifying price competition and compressing profit margins for original manufacturers [3].

Limited Indication Expansion

While current indications are substantial, the lack of type I expansion limits growth potential unless new therapeutic uses are developed and approved.

Manufacturing Complexities

Peptide synthesis and stabilization processes are delicate, demanding high-quality manufacturing standards. This complexity can constrain supply and escalate production costs.

Financial Trajectory and Revenue Forecasts

Revenue Growth Drivers

• Expansion of approved indications, notably for tumor control and symptom management.
• Entry of biosimilars offering more affordable options, widening patient access.
• Adoption of long-acting formulations in developed markets.
• Rising prevalence of target diseases globally.

Projected Market Trends

Analysts predict a steady CAGR of approximately 5% from 2023 to 2028. Revenue streams are expected to be sustained by existing formulations, with incremental gains from biosimilar entrants and pipeline products. For example, the launch of next-generation delivery systems could further boost revenues by improving patient compliance and reducing hospital visits.

Key Players and Market Share

Major pharmaceutical companies such as Novartis (manufacturer of Sandostatin® LAR), Teva, and Sandoz lead the market, holding significant shares due to their established manufacturing capabilities and global distribution networks. Biosimilar producers are gaining market share, offering lower-cost alternatives and challenging erstwhile market leaders [4].

Regulatory and Competitive Landscape

The regulatory environment remains favorable, with streamlined pathways for biosimilars in key regions. Nevertheless, patent litigations and exclusivity periods can influence market entry timings. Furthermore, emerging competitors investing in novel peptide synthesis methods could disrupt traditional players.

Future Market Opportunities

• Biosimilar Market Expansion: The growing biosimilar pipeline offers opportunities for cost reduction and increased accessibility.
• Combination Therapy Development: Combining octreotide with other targeted agents could improve therapeutic outcomes, opening new indications.
• Personalized Medicine Approaches: Genetic profiling may tailor treatments, expanding market scope.
• Innovative Delivery Technologies: Developing non-injectable or implantable formulations could enhance patient compliance and broaden demographic reach.

Conclusion

The octreotide acetate market is poised for moderate, sustained growth driven by increasing disease prevalence, formulation innovations, and expanding healthcare infrastructure. While high costs and biosimilar competition present challenges, strategic development of new formulations and indications will shape the financial trajectory. Market participants must navigate the evolving regulatory environment and technological innovations to optimize profitability.

Key Takeaways

• The global octreotide acetate market is expected to grow at approximately 5% annually, fueled by rising disease burdens and formulation advances.
• Biosimilars are disrupting traditional market dynamics, offering cost-effective options but intensifying competition.
• Long-acting formulations significantly enhance patient adherence and market penetration.
• High treatment costs remain a barrier in emerging markets, necessitating strategies for affordability and access.
• Investment in pipeline development, combination therapies, and delivery innovations represents a key avenue for future growth.

FAQs

1. What are the primary therapeutic indications for octreotide acetate?

Octreotide acetate is mainly used to treat acromegaly, neuroendocrine tumors, and symptoms associated with carcinoid and vasoactive intestinal peptide-secreting tumors. Its efficacy in hormone suppression and symptom control makes it a cornerstone in endocrine and oncological therapies.

2. How do biosimilars impact the octreotide acetate market?

Biosimilars introduce competitive pricing, reducing treatment costs and expanding patient access. They also intensify pricing pressures on branded formulations, prompting original manufacturers to innovate and diversify their portfolios.

3. What are the major challenges facing octreotide acetate producers?

High manufacturing costs, patent expirations, competition from biosimilars, and limited indication expansion pose significant hurdles. Ensuring supply chain robustness and managing regulatory hurdles also impact market stability.

4. Which regions are experiencing the fastest growth in octreotide use?

Emerging markets in Asia-Pacific and Latin America are witnessing rapid growth due to increasing disease prevalence, improved healthcare infrastructure, and rising healthcare expenditures, providing lucrative opportunities for producers.

5. What future innovations could influence the market’s trajectory?

Development of non-injectable or implantable delivery systems, expansion into new therapeutic areas through combination therapies, and personalized treatment approaches are poised to shape the future landscape.

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Sources:

[1] MarketWatch, “Octreotide Market Size, Share & Trends Analysis Report,” 2022.
[2] National Institutes of Health, “Prevalence of Acromegaly,” 2021.
[3] Novartis Annual Report, 2022.
[4] IQVIA Biosimilar Market Insights, 2022.