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Profile for Tradename: SANDOSTATIN LAR

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Sandostatin Lar is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug.

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

Summary for Tradename: SANDOSTATIN LAR

Suppliers / Packagers: see list7
2013 Sales:$697,961,000

Clinical Trials for: SANDOSTATIN LAR

Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients
Status: Completed Condition: Acromegaly

Ultrasound Guided Sandostatin LAR Injection in Acromegaly
Status: Recruiting Condition: Acromegaly

Effects of Sandostatin LAR® in Acromegaly
Status: Active, not recruiting Condition: Acromegaly

Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
Status: Terminated Condition: Acromegaly

Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis
Status: Completed Condition: Cirrhosis; Portal Hypertension; Esophageal Varices

Octreotide Compared to Placebo in Patients With Inoperable Bowel Obstruction Due to Peritoneal Carcinomatosis
Status: Completed Condition: Peritoneal Neoplasms; Intestinal Obstruction; Carcinomatosis

RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma
Status: Completed Condition: Neuroendocrine Carcinoma; Islet Cell Carcinoma

Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anaemia Due to Small Bowel Angiodysplasias
Status: Recruiting Condition: Angiodysplasia; Vascular Malformations; Gastrointestinal Hemorrhage; Anemia

Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas
Status: Active, not recruiting Condition: Well-differentiated Non-pancreatic Neuroendocrine Carcinoma

Pegvisomant And Sandostatin LAR Combination Study
Status: Completed Condition: Acromegaly

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
octreotide acetate
INJECTABLE;INJECTION021008-001Nov 25, 1998RXNo5,922,682*PED<disabled>Y<disabled>
octreotide acetate
INJECTABLE;INJECTION021008-002Nov 25, 1998RXNo5,688,530*PED<disabled>Y<disabled>
octreotide acetate
INJECTABLE;INJECTION021008-001Nov 25, 1998RXNo5,639,480*PED<disabled> <disabled>
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Non-Orange Book Patents for Tradename: SANDOSTATIN LAR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,538,739 Sustained release formulations of water soluble peptides<disabled in preview>
6,353,030 Relating to organic compounds<disabled in preview>
5,876,761 Sustained release formulations of water soluble peptides<disabled in preview>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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