SANDOSTATIN LAR Drug Patent Profile

Which patents cover Sandostatin Lar, and what generic alternatives are available?

Sandostatin Lar is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in SANDOSTATIN LAR 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 Lar

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

Summary for SANDOSTATIN LAR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	79
Drug Prices:	Drug price information for SANDOSTATIN LAR
DailyMed Link:	SANDOSTATIN LAR at DailyMed

See drug prices for SANDOSTATIN LAR

Recent Clinical Trials for SANDOSTATIN LAR

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
University Hospital, Antwerp	Phase 4

See all SANDOSTATIN LAR clinical trials

US Patents and Regulatory Information for SANDOSTATIN LAR

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

Expired US Patents for SANDOSTATIN LAR

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

International Patents for SANDOSTATIN LAR

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100303681
Hungary	203480	PROCESS FOR PRODUCING PARENTERAL PHARMACEUTICAL COMPOSITIONS CONTAINING SOMATOSTATIN ANALOGUES AS ACTIVE COMPONENTS
Greece	71636
Netherlands	9001537
South Africa	9710108	Osmotic delivery system and method for enhancing start-up and performance of osmotic delivery systems
Finland	803634

Supplementary Protection Certificates for SANDOSTATIN LAR

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

Market Dynamics and Financial Trajectory for SANDOSTATIN LAR

Last updated: December 12, 2025

Summary

Sandostatin LAR (lanreotide) is a long-acting peptide analog indicated primarily for treating neuroendocrine tumors (NETs), acromegaly, and certain carcinoid syndromes. As a flagship product of Novartis and previously by Novartis-acquired specialties, the drug’s market landscape is shaped by increasing prevalence of its indications, regulatory factors, patent status, and competitive forces. This analysis examines key market drivers, revenue trajectories, competitive dynamics, and future outlook, offering a comprehensive view for stakeholders.

---

What are the Context and Current Market Size for Sandostatin LAR?

Indications and Market Scope

Sandostatin LAR’s principal uses—neuroendocrine tumors and acromegaly—are rare but significantly impactful conditions with growing diagnosis rates owing to improved detection and awareness:

Indication	Global Prevalence (Est.)	Market Drivers
Neuroendocrine Tumors (NETs)	200,000–300,000 cases globally	Increased imaging, surveillance, and diagnosis awareness
Acromegaly	~50,000 cases worldwide	Advances in diagnostics, recognition of hypopituitarism
Carcinoid Syndrome	Part of NETs, with symptom management needs	Symptom control, peptide therapy adoption

Market Size

Based on IQVIA data (2022), the global NET therapeutics market, including peptide therapies like Sandostatin LAR, is valued at approximately USD 500 million and is projected to grow at a CAGR of 7.5% through 2030. The increasing patient pool, along with expanded indications, underpins revenue growth.

---

What Are the Key Market Dynamics Influencing Sandostatin LAR?

1. Growing Prevalence and Diagnosis

• Enhanced Detection: Advances in somatostatin receptor imaging (e.g., Gallium-68 PET scans) increase NET identification.
• Demographic Shifts: Aging populations in developed markets contribute to higher incidence rates.

2. Competitive Landscape

• Main Competitors: Octreotide (Sandostatin), Pasireotide, and emerging biosimilars.
• Market Share: Sandostatin LAR maintains approximately 60% share within long-acting somatostatin analogs, with newer agents gradually penetrating the market.
• Biosimilar Entry: Several biosimilars authorized in Europe and Asia (~USD 100-200 million potential share) could pressure prices.

3. Patent and Regulatory Factors

• Patent Expiry: The original patent expired in 2016 in some jurisdictions, prompting generic and biosimilar competition.
• Regulatory Approvals: Fast track and orphan drug designations aid market exclusivity; ongoing approvals for additional indications can extend revenue streams.

4. Pricing and Reimbursement Policies

• Price varies globally:
  • In US: Approx. USD 8,000–USD 10,000 per month per patient.
  • In Europe: Generally lower but with strict reimbursement criteria.
• Reimbursement trends: Favorable reimbursement in developed markets bolsters steady sales; emerging markets face reimbursement challenges.

5. Off-Label Uses and Emerging Indications

• Exploratory use in diverse tumors and hormonal syndromes could impact demand.
• Clinical trials (e.g., NCT05743921) indicate future expansion potential.

---

How Has the Financial Performance of Sandostatin LAR Evolved?

Year	Global Sales (USD millions)	Notes
2016	1,050	Post-patent expiry, slight decline
2018	950	Market saturation, biosimilar entry
2020	1,100	Slight rebound, new indications
2022	1,200	Recovery bolstered by diagnosis rates

Source: IQVIA (2022), Company reports.

Revenue Breakdown by Region

Region	Share of Total Sales	Key Factors
North America	50%	High prevalence, reimbursement
Europe	30%	Strong market presence, approvals
Asia-Pacific	15%	Emerging growth opportunities
Other	5%	Limited, mainly in clinical trials

Profitability Analysis

• Gross margins hover around 75-80% due to manufacturing efficiencies.
• Competitive pricing and biosimilar pressure threaten margin sustainability.

---

What Is the Future Outlook for Sandostatin LAR?

Growth Drivers

• Expanded Indications: Ongoing trials in neuroendocrine carcinomas and other hormonal syndromes.
• Market Penetration: Increasing treatment adoption in Asia-Pacific, Latin America.
• Novel Delivery Techniques: Development of less invasive and more patient-friendly formulations.

Risks and Challenges

• Patent Litigation and Biosimilars: Erosion of exclusive rights post-2016.
• Pricing Pressure: Globally tightening healthcare budgets.
• Competitive Innovation: New molecular entities with improved profiles.

Projected Revenue Trajectory (2023–2030)

Year	Projected Sales (USD millions)	Compound Annual Growth Rate
2023	1,250	4-6%
2025	1,400
2030	1,800

Diverse estimates indicate a gradual recovery and growth, assuming ongoing clinical success and expanded global access.

---

How Does Sandostatin LAR Compare with Competitors?

Parameter	Sandostatin LAR (Lanreotide)	Octreotide	Pasireotide	Emerging Biosimilars
Indications	NETs, Acromegaly, Carcinoid	Similar	Similar, more hormonal syndromes	Similar
Delivery Method	Deep subcutaneous injection	Injectable	Injectable	Injectable
Frequency	Once every 4 weeks	1-4 weekly	Weekly or monthly	Weekly or monthly
Market Share	~60%	~30% (US)	Niche	Increasing in select regions
Price (approximate)	USD 8,000–USD 10,000/month	USD 7,000–USD 9,000/month	Similar	Competitive with generics

Note: Biosimilar prices are typically 20-30% lower.

---

What Are the Key Regulatory Frameworks and Policies Impacting Sandostatin LAR?

Global Regulatory Landscape

Region	Key Agencies	Policies Affecting Market
US	FDA	Orphan Drug Designation; Accelerated Approval pathways
Europe	EMA	Similar incentives under the EU Orphan Regulation
Japan	PMDA	Fast-track approval for rare diseases
Emerging Markets	Local agencies	Varied; often less strict, leading to price and access disparities

Pricing & Reimbursement Policies

• Emphasize value-based models in developed markets.
• Reimbursement approvals tied to clinical efficacy, especially in Europe.

---

Comparison Table: Sandostatin LAR and Key Market Factors

Factor	Details	Impact
Patent Status	Expired in key markets (post-2016)	Entry of biosimilars, price pressure
Indication Expansion	Ongoing clinical trials for new tumor types	Future revenue streams
Manufacturing & Supply Chain	Proven, scalable bioproduction facilities	Cost efficiencies, reliable supply
Market Penetration	High in mature markets, developing in Asia, Latin America	Growth opportunities in emerging markets
Patient Advocacy & Awareness	Growing advocacy drives diagnosis rates	Increased utilization

---

Key Takeaways

• Market maturity with ongoing biosimilar competition, but strong demand driven by increasing diagnosis and expanded indications.
• Revenue exhibited resiliency post-patent expiry, with potential to grow with market expansion, especially in Asia-Pacific.
• Pricing pressures necessitate innovation in delivery and formulation, alongside strategic pricing.
• Regulatory pathways and policies favor ongoing approvals in orphan and rare diseases, maintaining access.
• Competitive landscape demands continuous differentiation and pipeline expansion.

---

Frequently Asked Questions (FAQs)

1. How will biosimilars impact Sandostatin LAR’s market share?

Biosimilars, entering in various regions post-patent expiry, are expected to reduce prices and erode the market share of the original product, especially in Europe and Asia. While they may erode margins, they also broaden access, potentially expanding overall market size.

2. What are key innovations that could extend Sandostatin LAR’s lifecycle?

Development of next-generation formulations, less invasive delivery methods, and expanding indications into other hormonal or neuroendocrine-related tumors will bolster long-term relevance.

3. How significant is the role of regulatory policies in shaping the market?

Regulatory incentives like orphan drug designations and accelerated approval pathways promote access and can extend exclusivity periods, directly influencing sales trajectories.

4. What geographic markets present the greatest growth potential?

Emerging markets in Asia-Pacific, Latin America, and the Middle East show high potential due to rising diagnosis rates, expanding healthcare infrastructure, and increasing awareness.

5. How does the competitive landscape influence pricing strategies?

Intense competition from biosimilars and other peptide therapies pressures price points, incentivizing manufacturers to innovate in dosing, administration, and indications to maintain profitability.

---

References

[1] IQVIA (2022). "Pharmaceutical Market Reports."
[2] Novartis Annual Reports (2016–2022). “Sandostatin LAR Revenue & Strategy.”
[3] European Medicines Agency (EMA). "Sandostatin LAR Product Information," 2016.
[4] ClinicalTrials.gov. "Current Studies on Lanreotide," 2022.
[5] GlobalData. "Neuroendocrine Tumor Market Analysis," 2022.