SANDOSTATIN Drug Patent Profile

Which patents cover Sandostatin, and when can generic versions of Sandostatin launch?

Sandostatin is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in SANDOSTATIN is octreotide acetate. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sandostatin

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

Summary for SANDOSTATIN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	79
Drug Prices:	Drug price information for SANDOSTATIN
What excipients (inactive ingredients) are in SANDOSTATIN?	SANDOSTATIN excipients list
DailyMed Link:	SANDOSTATIN at DailyMed

See drug prices for SANDOSTATIN

Recent Clinical Trials for SANDOSTATIN

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

Sponsor	Phase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	PHASE2
Clinica Universidad de Navarra, Universidad de Navarra	Phase 2
Belgium Health Care Knowledge Centre	Phase 4

See all SANDOSTATIN clinical trials

Pharmacology for SANDOSTATIN

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Paragraph IV (Patent) Challenges for SANDOSTATIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 SANDOSTATIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-001	Oct 21, 1988	AP	RX	Yes	Yes
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-002	Nov 25, 1998	AB	RX	Yes	No
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-003	Oct 21, 1988	AP	RX	Yes	Yes
Novartis	SANDOSTATIN LAR	octreotide acetate	INJECTABLE;INJECTION	021008-003	Nov 25, 1998	AB	RX	Yes	Yes
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-002	Oct 21, 1988	AP	RX	Yes	Yes
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-004	Jun 12, 1991		DISCN	Yes	No

Expired US Patents for SANDOSTATIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-001	Oct 21, 1988
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-005	Jun 12, 1991
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-004	Jun 12, 1991
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-003	Oct 21, 1988
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-005	Jun 12, 1991
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-003	Oct 21, 1988

International Patents for SANDOSTATIN

See the table below for patents covering SANDOSTATIN around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	618270
Greece	71636
Portugal	87957	PROCESSO PARA A PREPARACAO DE UMA COMPOSICAO FARMACEUTICA CONTENDO UM ANALOGO DA SOMATOSTATINA
Denmark	385488
Sweden	8802569
Switzerland	677449

Supplementary Protection Certificates for SANDOSTATIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0029579	SPC/GB93/097	United Kingdom

Market Dynamics and Financial Trajectory for SANDOSTATIN

Last updated: February 28, 2026

What Is SANDOSTATIN and How Is It Used?

SANDOSTATIN (octreotide) is a synthetic somatostatin analog. Approved by the FDA in 1988, it treats acromegaly, symptoms from neuroendocrine tumors, and prevents postoperative bleeding. Marketed by Novartis and currently also by other stakeholders in generic forms, the drug is administered via injection.

Market Size and Key Drivers

Global Market Valuation

The global somatostatin analogs market, including SANDOSTATIN, was valued at approximately USD 2.5 billion in 2022. It is projected to reach USD 4 billion by 2030, growing at a CAGR of around 6% (ResearchAndMarkets, 2023).

Major Application Segments

• Acromegaly: Accounts for roughly 40% of sales.
• Neuroendocrine Tumors (NETs): Approximately 50% of revenue.
• Other Uses: Includes carcinoid syndrome, to lesser degrees.

Volume Trends

In the US, prescriptions for octreotide were about 150,000 annually in 2022, up from 100,000 in 2018, reflecting increased diagnosis and treatment of neuroendocrine tumors.

Competitive Landscape

Key Players

• Novartis: Patent holder and primary manufacturer.
• Sandoz (a Novartis division): Produces generic formulations.
• Other Generics: Increasing market entry in regions with patent expirations.

Patent and Regulatory Status

Novartis held patent protection until 2015, after which generic versions entered multiple markets, intensifying competition. In the US, the first generic was approved in 2015, causing price erosion.

Pricing and Reimbursement

Price Trends

• Brand-Name (Sandostatin): Approximate annual cost per patient: USD 40,000.
• Generics: Prices range from USD 15,000 to USD 25,000 annually, depending on formulation and market.

Reimbursement Policies

Reimbursement covers both brand and generic drugs, with insurance coverage in developed markets. Price negotiations and formularies influence overall revenue.

R&D and Pipeline Developments

Emerging Indications

Research focuses on expanding use for conditions like gastrointestinal bleeding and pediatric tumors. Clinical trials are ongoing for new delivery methods and formulations.

Biosimilars and Next-Generation Analogues

Several biosimilars are in late-stage development, aiming to lower costs and increase access, particularly in emerging markets.

Financial Trajectory Insights

Revenue Trends

SANDOSTATIN’s global sales grew steadily pre-2015, then plateaued due to generic competition. Post-2015, revenues declined in developed markets but stabilized in emerging regions due to increased demand and local approval of biosimilars.

Market Share Dynamics

In 2022, SANDOSTATIN maintained over 60% of the somatostatin analogs market, with generics capturing the remaining share.

Profitability Outlook

Gross margins for proprietary formulations exceed 70%, while generics have margins around 30-40%. Future revenue hinges on new indications, biosimilars, and market expansion.

Key Challenges and Opportunities

Challenges

• Patent expirations and rising generic competition.
• Price erosion pressures.
• Regulatory hurdles for new indications.

Opportunities

• Expansion into underserved markets.
• Development of new formulations for better patient compliance.
• Broader indications for existing molecules.

Summary Table: Market and Financial Overview

Aspect	Detail
Market Valuation (2022)	USD 2.5 billion
Projected Market (20230)	USD 4 billion
CAGR (2022–2030)	6%
Main Application Segments	Acromegaly (40%), NETs (50%)
US Prescriptions (2022)	~150,000/year
Average US Price (Brand)	USD 40,000/year
Generic Price Range	USD 15,000–25,000/year
Patent Expiry	2015 (US)
Market Share (2022)	>60% held by SANDOSTATIN

Key Takeaways

• SANDOSTATIN remains a significant player in neuroendocrine tumor treatment, with stable or growing demand in emerging markets.
• Patent expirations led to increased generic competition, causing revenue declines in mature markets.
• Future growth depends on expanding indications, biosimilar penetration, and new delivery methods.
• Price pressures continue amid market saturation, but profitability remains high for original formulations.
• Regulatory and market access will shape the trajectory of revenues and market share in the coming years.

FAQs

Q1: How will biosimilars impact SANDOSTATIN's market share?
Biosimilars are likely to reduce prices and increase access, potentially decreasing SANDOSTATIN’s market dominance but expanding overall treatment use.

Q2: What regions offer the most growth opportunities?
Emerging markets in Asia-Pacific and Latin America present growth prospects due to increasing diagnosis and less mature competition.

Q3: Are there significant pipeline developments for new indications?
Yes, ongoing trials aim to expand use for gastrointestinal bleeding, pediatric tumors, and other neuroendocrine disorders.

Q4: How do reimbursement policies affect sales?
Reimbursement coverage varies; higher reimbursement levels in developed markets support sustained sales, while access issues in lower-income regions constrain growth.

Q5: When are new biosimilar entries expected?
Several biosimilars are in late-stage development, with first-launch likely within the next 2–3 years, depending on regional regulatory approvals.

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Sources:
[1] ResearchAndMarkets. (2023). Global Somatostatin Analogs Market.
[2] FDA. (1988). Sandostatin (octreotide) approval.
[3] IQVIA. (2022). Prescription Data for Neuroendocrine Tumors.