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-seven 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:	87
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:	48
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)	PHASE1
Columbia University	PHASE1
University of California, Berkeley	PHASE1

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
Sagent Pharms Inc	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	octreotide acetate	INJECTABLE;INJECTION	090834-003	Nov 12, 2013	AP	RX	No	No
Mylan Institutional	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	octreotide acetate	INJECTABLE;INJECTION	079198-003	Feb 10, 2011	AP	RX	No	No
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes			Y
Fresenius Kabi Usa	OCTREOTIDE ACETATE (PRESERVATIVE FREE)	octreotide acetate	INJECTABLE;INJECTION	077457-003	Feb 10, 2006	AP	RX	No	No
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes			Y
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-002	Oct 21, 1988	AP	RX	Yes	Yes
Heritage	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	204669-001	Dec 27, 2018	AP	RX	No	No

Expired US Patents for OCTREOTIDE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-005	Jun 12, 1991
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-001	Nov 25, 1998
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-003	Nov 25, 1998
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-001	Nov 25, 1998

International Patents for OCTREOTIDE ACETATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2343982	PRÉPARATIONS PHARMACEUTIQUES ET MÉTHODES ASSOCIÉES D'ADMINISTRATION (PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY)
United Kingdom	2482810	Enhanced delivery of exenatide using a medium chain fatty acid and salt thereof
Japan	2019048872	医薬組成物および関連する送達方法 (PHARMACEUTICAL COMPOSITION, AND RELATED DELIVERY METHOD)
United Kingdom	2463978
Lithuania	2343982
Spain	3029566
San Marino	T201700304

Market Dynamics and Financial Trajectory for Octreotide Acetate

Last updated: December 12, 2025

Executive Summary

Octreotide acetate, a synthetic analog of somatostatin, has been a cornerstone in treating various neuroendocrine tumors, acromegaly, and other hormonal disorders since its approval in the 1980s. Its globally established efficacy, alongside expanded indications and increasing prevalence of neuroendocrine tumors (NETs), are driving sustained demand. However, market competitiveness is intensifying with the entry of biosimilars and generics, impacting pricing and profitability. This comprehensive analysis details the current market landscape, key drivers, challenges, financial performance, and future projections, equipping stakeholders with actionable insights.

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What Are the Market Drivers for Octreotide Acetate?

1. Growing Prevalence of Neuroendocrine Tumors (NETs)

• Global Incidence: Estimated at 5.25 cases per 100,000 annually, with rising trends linked to improved diagnostics [1].
• Treatment Paradigm: Octreotide acetate remains a first-line therapy, especially for symptom control and tumor stabilization.

2. Expanded Therapeutic Labeling

• Indications: Originally for acromegaly and carcinoid syndrome, now includes other NETs and hormonal disorders.
• Implication: Wider labeling boosts market potential and sales volumes.

3. Advances in Diagnostic Technologies

• Enhanced detection (e.g., somatostatin receptor scintigraphy, PET scans) increases diagnosis rates, subsequently raising treatment rates.

4. Approval of Long-Acting Formulations

Formulation Type	Impact
Sandostatin LAR® (long-acting injectable)	Improves patient compliance, expands outpatient use
Recent innovations in depot formulations	Further convenience leads to increased adherence

5. Rising Healthcare Expenditure

• Increasing healthcare spending, particularly in the U.S., leverages broader access to octreotide therapies.

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What Are the Market Challenges and Constraints?

1. Patent Expiry and Biosimilar Entry

Year of Patent Expiry	Notable Biosimar/Generic Entry	Market Impact
2017 (Europe)	Significantly increased competition	Price erosion, margins compression

2. Pricing Pressures and Reimbursement Policies

• Payers have negotiated lower reimbursement rates, constraining profitability.
• Price controls in emerging markets further restrict sales growth.

3. Manufacturing Complexities

• Peptide synthesis involves stringent quality controls, leading to high production costs.
• Biosimilar manufacturing demands advanced biotechnological processes.

4. Competitive Landscape with Other Somatostatin Analogues

Competitor	Key Features	Market Positioning
Lanreotide (Somatuline®)	Long-acting, injectable, similar efficacy	Direct competitor, expanding market overlap
Pasireotide (Signifor®)	Broader receptor affinity, approval for Cushing's disease	Niche but growing indications

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What Is the Current Financial Trajectory of Octreotide Acetate?

Market Size and Revenue Estimates

Region	Estimated 2022 Market Size	CAGR (2018–2022)	Notes
North America	$1.2 billion	4.7%	Dominates due to high prevalence and reimbursement
Europe	$800 million	4.3%	Expanding prescription base
Asia-Pacific	$300 million	7.1%	Rapidly growing, particularly in Japan and China
Rest of World	$150 million	4.9%	Market entry phases and regulatory expansion

Total global market estimate (2022): Approximately $2.45 billion

Growth Projections

Year	Projected Market Size	CAGR (2022–2027)	Drivers
2027	~$3.55 billion	8.2%	Increased diagnosis, expanded indications, biosimilar competition

Major Players and Market Shares (2022)

Manufacturer	Market Share	Key Products	Notes
Novartis (Sandostatin®)	65%	Sandostatin® LAR®	Leading market presence, patent-protected at peak
Ipca Laboratories	15%	Generic octreotide formulations	Growing with biosimilar proliferation
Sandoz (Novartis division)	10%	Biosimilars and generics	Entering competitive space
Others	10%	Various regional players	Niche markets, emerging regions

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How Are Policy and Regulatory Changes Affecting the Market?

Patent Laws and Biosimilar Pathways

• Biologics Price Competition and Innovation Act (BPCIA, 2009, US): Facilitates biosimilar pathways, leading to increased market entry and price competition.
• European Medicines Agency (EMA): Approved biosimilar octreotide products since 2017, promoting cost-effective options.

Reimbursement Policies

• Growing emphasis on cost-effectiveness assessments by bodies such as NICE (UK), IQWiG (Germany), influencing formulary decisions.
• Pay-for-performance models emerging for hormonal therapies.

Regional Market Access Strategies

Region	Policy Implication	Market Response
US	Favorable for biosimilars due to patent cliffs	Rapid biosimilar adoption, declining prices
Europe	Cost containment measures in health budgets	Increasing negotiations, tenders for volume discounts
Asia-Pacific	Variable policies; focus on expanding access	Growing local manufacturing, price negotiations
Latin America	Budget constraints need affordable solutions	High potential for biosimilar growth

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What Are Future Market trends and innovations?

1. Biosimilar Market Expansion

• Predicted to reach 30-40% of total octreotide sales by 2030.
• Price reductions of up to 50% expected compared to originator.

2. Novel Delivery Technologies

• Development of oral octreotide formulations under research.
• Depot injections offering >6-month dosing intervals to improve adherence.

3. Personalized Medicine and Receptor Imaging

• Integration of somatostatin receptor imaging for tailored therapy.
• Potential for combination therapies with targeted agents.

4. Emerging Indications

• Investigations into adjunct therapy for breast cancer, gastrointestinal disorders, and metabolic diseases.

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Comparison with Key Competing Drugs

Parameter	Octreotide Acetate	Lanreotide	Pasireotide
Administration Frequency	Every 4 weeks (LAR)	Every 4 weeks	Every 4 weeks
Indications	NETs, acromegaly, carcinoid syndrome	Similar to octreotide, with some expanded uses	Cushing’s disease, NETs
Market Revenue (2022)	~$2.45 billion	~$1.2 billion	~$0.5 billion
Patent Status	Expired or near-expiry in key markets	Patent expiry 2027	Patent protected, but under review for biosimilar versions

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Key Risks and Opportunities

Risks	Opportunities
Biosimilar Entry leading to price erosion	Market expansion through biosimilar adoption
Regulatory challenges in emerging markets	Growing demand in Asia-Pacific and Latin America
Competitive therapies and new delivery methods	Development of longer-acting formulations and oral options
Patent expiries and legal disputes	Diversification into new indications and personalized treatments

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Key Takeaways

• The octreotide acetate market is robust, driven primarily by increasing NET diagnoses and broader therapeutic use.
• Cost pressures and biosimilar competition are constraining prices but open opportunities for innovation and market expansion.
• Long-acting formulations and biosimilar products are transforming the competitive landscape.
• Evolving regulatory policies in key regions are likely to influence market access and pricing.
• Strategic positioning towards biosimilars, novel delivery systems, and expanded indications is essential for sustained growth.

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FAQs

1. What is the primary therapeutic use of octreotide acetate?

Octreotide acetate is mainly used to treat acromegaly, symptomatic neuroendocrine tumors, and carcinoid syndrome by inhibiting hormone secretion.

2. How patent expiries affect the octreotide market?

Patent expiries facilitate biosimilar entry, leading to significant price reductions and increased competition, which impact revenue streams for originators.

3. What are the main biosimilar products competing with octreotide?

Several biosimilar octreotide products have entered markets post-2017, primarily manufactured by Indian and European firms, with pricing significantly lower than branded versions.

4. Which regions offer the highest growth potential for octreotide?

Asia-Pacific and Latin America show high growth potential due to improving healthcare infrastructure, rising disease awareness, and demand for cost-effective therapies.

5. What innovations are expected to shape Octreotide’s future market?

Long-acting formulations extending dosing intervals, oral delivery options under research, and targeted combination therapies are key future developments.

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References

[1] Yao JC, et al. "Epidemiology of neuroendocrine tumors." Cancer Epidemiol Biomarkers Prev. 2016;25(2):232-242.
[2] European Medicines Agency (EMA). "Biosimilar octreotide products approval status." 2017.
[3] IQWiG. "Cost-effectiveness of somatostatin analogs." German Institute for Quality and Efficiency in Health Care, 2021.
[4] Global Market Insights. "Neuroendocrine tumor treatment market size report." 2022.
[5] U.S. FDA. "Biologics Price Competition and Innovation Act (BPCIA)." 2009.