SOMATULINE DEPOT Drug Patent Profile

Which patents cover Somatuline Depot, and what generic alternatives are available?

Somatuline Depot is a drug marketed by Ipsen Pharma and is included in one NDA.

The generic ingredient in SOMATULINE DEPOT is lanreotide acetate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanreotide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Somatuline Depot

A generic version of SOMATULINE DEPOT was approved as lanreotide acetate by INVAGEN PHARMS on December 17^th, 2021.

Summary for SOMATULINE DEPOT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	27
Patent Applications:	1,802
What excipients (inactive ingredients) are in SOMATULINE DEPOT?	SOMATULINE DEPOT excipients list
DailyMed Link:	SOMATULINE DEPOT at DailyMed

Recent Clinical Trials for SOMATULINE DEPOT

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

Sponsor	Phase
University Hospital, Antwerp	Phase 4
Belgium Health Care Knowledge Centre	Phase 4
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 4

See all SOMATULINE DEPOT clinical trials

Pharmacology for SOMATULINE DEPOT

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

US Patents and Regulatory Information for SOMATULINE DEPOT

SOMATULINE DEPOT is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-001	Aug 30, 2007	AB	RX	Yes	Yes
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-002	Aug 30, 2007	AB	RX	Yes	Yes
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-003	Aug 30, 2007	AB	RX	Yes	Yes

Expired US Patents for SOMATULINE DEPOT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-001	Aug 30, 2007
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-003	Aug 30, 2007
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-002	Aug 30, 2007

International Patents for SOMATULINE DEPOT

See the table below for patents covering SOMATULINE DEPOT around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2295745
Spain	2141956
Spain	2248206
Austria	280599
China	101590011

Supplementary Protection Certificates for SOMATULINE DEPOT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0779805	CA 2002 00032	Denmark
0779805	91037	Luxembourg		91037, EXPIRES: 20160511

SOMATULINE DEPOT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SOMATULINE DEPOT

Introduction

SOMATULINE DEPOT, a somatostatin analog marketed by Ipsen, is indicated for the treatment of various conditions, including gastroenteropancreatic neuroendocrine tumors (GEP-NETs), carcinoid syndrome, and acromegaly. This article delves into the market dynamics and financial trajectory of SOMATULINE DEPOT, highlighting its clinical significance, market position, and economic impact.

Clinical Indications and Efficacy

SOMATULINE DEPOT is used for the long-term treatment of patients with GEP-NETs, carcinoid syndrome, and acromegaly. It has been shown to improve progression-free survival (PFS) in patients with GEP-NETs and reduce the frequency of short-acting somatostatin analog (SSA) rescue therapy for carcinoid syndrome[1][3].

Market Position

SOMATULINE DEPOT competes in the market for somatostatin analogs, primarily against octreotide long-acting release (LAR). The market share of SOMATULINE DEPOT has been increasing, driven by its efficacy and cost-effectiveness. Studies have shown that a shift from octreotide LAR to SOMATULINE DEPOT can result in significant cost savings for hospitals, with an estimated annual cost savings of over $400,000 per US hospital when the market share of SOMATULINE DEPOT increases from 5% to 30%[1].

Economic Impact

The economic analysis of SOMATULINE DEPOT versus octreotide LAR highlights several key points:

• Cost Savings: The use of SOMATULINE DEPOT can lead to substantial cost savings due to lower acquisition prices and reduced costs associated with preparation and administration[1].
• Budget Impact Modeling: Real-world data (RWD) plays a crucial role in budget impact modeling, as it helps in accurately estimating the costs and benefits of treatment choices. The inclusion of RWD in economic models has shown that increased utilization of SOMATULINE DEPOT can result in significant cost savings[1].

Adverse Reactions and Safety Profile

While SOMATULINE DEPOT is generally well-tolerated, it is associated with several adverse reactions, including abdominal pain, musculoskeletal pain, vomiting, headache, injection site reactions, hyperglycemia, hypertension, and cholelithiasis. These reactions are similar across different indications, such as GEP-NETs and carcinoid syndrome[3].

Patient Experience and New Technologies

Ipsen has invested in a new state-of-the-art electronic autoinjector for SOMATULINE DEPOT, aimed at improving patient experience. This fourth-generation device, developed in collaboration with Phillips-Medisize, is expected to enhance the administration and injection experience for patients. The first launches of this new device are anticipated in 2024[4].

Financial Performance of Ipsen

While the financial performance of Ipsen as a whole is not solely dependent on SOMATULINE DEPOT, the drug is a significant contributor to the company's revenue. Ipsen's investment in new technologies and manufacturing capabilities, such as the enhanced investment in the Signes manufacturing site in France, reflects the company's commitment to maintaining and expanding its market share in the somatostatin analog market[4].

Competitive Landscape

The market for somatostatin analogs is competitive, with other players like Crinetics Pharmaceuticals focusing on different therapeutic areas but also involved in the broader endocrinology space. However, SOMATULINE DEPOT's established position and ongoing innovations, such as the new electronic autoinjector, help it maintain a strong market presence[2][5].

Future Outlook

The future outlook for SOMATULINE DEPOT is promising, driven by its clinical efficacy, cost-effectiveness, and ongoing technological advancements. As the market continues to evolve, the integration of real-world data into economic models will remain crucial for demonstrating the value of SOMATULINE DEPOT to healthcare providers and payers.

Key Takeaways

• Clinical Efficacy: SOMATULINE DEPOT is effective in treating GEP-NETs, carcinoid syndrome, and acromegaly.
• Cost-Effectiveness: The drug offers significant cost savings compared to octreotide LAR.
• Technological Advancements: The new electronic autoinjector is expected to improve patient experience.
• Market Position: SOMATULINE DEPOT has a strong market presence with increasing market share.
• Economic Impact: Real-world data is critical in demonstrating the economic benefits of SOMATULINE DEPOT.

Frequently Asked Questions

Q1: What are the primary indications for SOMATULINE DEPOT? SOMATULINE DEPOT is indicated for the treatment of adult patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs), carcinoid syndrome, and acromegaly who have had an inadequate response to other treatments.

Q2: How does SOMATULINE DEPOT compare to octreotide LAR in terms of cost? Studies have shown that SOMATULINE DEPOT can result in significant cost savings compared to octreotide LAR, primarily due to lower acquisition prices and reduced preparation and administration costs.

Q3: What are the common adverse reactions associated with SOMATULINE DEPOT? Common adverse reactions include abdominal pain, musculoskeletal pain, vomiting, headache, injection site reactions, hyperglycemia, hypertension, and cholelithiasis.

Q4: What new technology is being introduced for SOMATULINE DEPOT? Ipsen is introducing a new state-of-the-art electronic autoinjector designed to improve the administration and injection experience for patients.

Q5: How does the use of real-world data impact the economic analysis of SOMATULINE DEPOT? The inclusion of real-world data in economic models helps in accurately estimating the costs and benefits of treatment choices, demonstrating significant cost savings with increased utilization of SOMATULINE DEPOT.

Cited Sources

1. Investigating the Generation of Real-World Evidence - Amazon S3
2. Crinetics Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update - Biospace
3. Overview of Formative Studies Leading to the Redesigned SOMATULINE® DEPOT - Somatuline Depot
4. Ipsen announces investment in new state-of-the-art electronic autoinjector for Somatuline® Autogel® / Somatuline® Depot - Ipsen
5. Crinetics Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Corporate Update - Biospace