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. Eleven 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:	78
Patent Applications:	3,820
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
Clinica Universidad de Navarra, Universidad de Navarra	Phase 2
University Hospital, Antwerp	Phase 4
ZonMw: The Netherlands Organisation for Health Research and Development	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

Expired US Patents for SANDOSTATIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-005	Jun 12, 1991	4,395,403
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-002	Oct 21, 1988	5,753,618*PED
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-003	Oct 21, 1988	5,753,618*PED
Novartis	SANDOSTATIN	octreotide acetate	INJECTABLE;INJECTION	019667-001	Oct 21, 1988	4,395,403

International Patents for SANDOSTATIN

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

Country	Patent Number	Title	Estimated Expiration
Spain	510751
South Korea	100195894
United Kingdom	8716326
New Zealand	225340	PHARMACEUTICAL COMPOSITIONS COMPRISING SOMATOSTATIN ANALOGUES AND LACTIC ACID

Supplementary Protection Certificates for SANDOSTATIN

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

SANDOSTATIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sandostatin

Overview of Sandostatin

Sandostatin, also known as octreotide acetate, is a somatostatin analog used in the treatment of various conditions, including neuroendocrine tumors, bleeding esophageal varices, and other related disorders. It is a key product in Novartis's pharmaceutical portfolio.

Market Size and Forecast

The global Sandostatin LAR market was valued at approximately $1.238 billion in 2023. However, it is forecasted to decline to $680.3 million by 2030, reflecting a compound annual growth rate (CAGR) of -6.8% during the forecast period of 2024-2030[1].

Key Market Segments

By Type

The Sandostatin LAR market is segmented by type, with the main categories being 500mcg, 1000mcg, and other formulations. The 500mcg and 1000mcg formulations are significant due to their widespread use and efficacy in treating various conditions[1][4].

By Application

The market is also segmented by application, with primary uses including tumors, bleeding esophageal varices, and other medical conditions. The increasing prevalence of neuroendocrine tumors is expected to boost the demand for Sandostatin LAR in the coming years[1][4].

By Region

The global market is analyzed by region, with different regions exhibiting varying growth rates and market sizes. The market dynamics can be influenced by regional healthcare policies, patient demographics, and the availability of alternative treatments[1][4].

Financial Performance of Novartis

Novartis, the primary manufacturer of Sandostatin, has seen mixed financial performance in recent years.

Sales Growth

In the first quarter of 2024, the Sandostatin group reported sales of $355 million, representing an 8% increase (9% in constant currency) primarily driven by inventory shipments in the US[2].

Overall Financial Outlook

Novartis's overall financial outlook is supported by strong performance from other key drugs such as Entresto, Cosentyx, and Kesimpta. However, the company faces potential challenges from future generic competition and the loss of exclusivity (LOEs) for some of its drugs[3].

Competitive Landscape

Avoiding Generic Competition

Novartis has managed to avoid generic competition for key drugs like Sandostatin and Tasigna, which has supported its short-term financial outlook. However, the likelihood of future generic entries could impact the company's performance[3].

Patent Protection

Octreotide acetate, the active ingredient in Sandostatin, is protected by several patents, with 71 patent family members in 25 countries and 15 patents in the US. This patent protection helps in maintaining market exclusivity for Novartis[5].

Growth Drivers and Challenges

Growth Drivers

• Increasing Prevalence of Neuroendocrine Tumors: The rising incidence of neuroendocrine tumors is expected to drive the demand for Sandostatin LAR[4].
• Strong Performance of Other Novartis Drugs: The continued strong performance of other Novartis drugs like Cosentyx, Kisqali, and Kesimpta supports the company's overall growth trajectory[3].

Challenges

• Future Generic Competition: The potential entry of generic versions of Sandostatin and other Novartis drugs could significantly impact the company's revenue[3].
• Loss of Exclusivity: The anticipated loss of exclusivity for drugs like Promacta and Entresto may slow down Novartis's growth rate in the future[3].

Regional Analysis

The global Sandostatin LAR market is expected to be dominated by certain regions due to factors such as healthcare infrastructure, patient population, and regulatory environments. The market report provides detailed regional analysis, including country-level data, to help understand the market dynamics better[1][4].

Market Trends and Opportunities

Increasing Demand for Somatostatin Analogs

The demand for somatostatin analogs like Sandostatin is increasing due to their efficacy in treating various medical conditions. This trend is expected to continue, driven by advancements in medical research and the growing awareness of neuroendocrine tumors[4].

Technological Advancements

Technological advancements in drug delivery systems and the development of new formulations could present opportunities for growth in the Sandostatin LAR market[4].

Financial Projections and Outlook

Revenue Forecast

The decline in the Sandostatin LAR market size from $1.238 billion in 2023 to $680.3 million by 2030 reflects the challenges posed by potential generic competition and the loss of exclusivity for some of Novartis's key drugs[1].

Operating Income and Margins

Novartis's operating income margin has improved, driven by higher net sales and lower restructuring charges. However, the company faces challenges in maintaining these margins due to future competitive pressures[2].

Key Takeaways

• Market Size and Forecast: The global Sandostatin LAR market is forecasted to decline to $680.3 million by 2030.
• Key Segments: The market is segmented by type (500mcg, 1000mcg) and application (tumors, bleeding esophageal varices).
• Financial Performance: Novartis's sales of Sandostatin have been strong, but the company faces future challenges from generic competition.
• Competitive Landscape: Patent protection and strong performance of other Novartis drugs support the company's financial outlook.
• Growth Drivers and Challenges: Increasing prevalence of neuroendocrine tumors and potential generic competition are key factors.

FAQs

What is the forecasted market size of Sandostatin LAR by 2030?

The global Sandostatin LAR market is forecasted to be worth $680.3 million by 2030[1].

Which company is the main player in the Sandostatin LAR market?

Novartis is the main player in the Sandostatin LAR market[1].

What are the primary applications of Sandostatin LAR?

The primary applications include tumors, bleeding esophageal varices, and other medical conditions[1].

How has Novartis managed to avoid generic competition for Sandostatin?

Novartis has managed to avoid generic competition for Sandostatin through patent protection and strategic market positioning[3][5].

What are the key growth drivers for the Sandostatin LAR market?

The increasing prevalence of neuroendocrine tumors and the strong performance of other Novartis drugs are key growth drivers[3][4].

Sources

1. Valuates Reports: "Sandostatin LAR - Market, Report Size, Worth, Revenue, Growth"
2. Novartis: "Condensed Interim Financial Report – Supplementary Data"
3. Markets Insider: "Novartis AG: A Balanced View of Opportunities and Challenges Ahead"
4. Cognitive Market Research: "Sandostatin LAR Market Report 2024 (Global Edition)"
5. DrugPatentWatch: "OCTREOTIDE ACETATE - Generic Drug Details"