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Details for Generic Name: octreotide acetate

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Octreotide acetate is the generic ingredient in four branded drugs marketed by Eurohlth Intl Sarl, Fresenius Kabi Usa, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, Wockhardt Usa, Mylan Institutional, and Novartis, and is included in eighteen NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for octreotide acetate. Two suppliers are listed for this compound.

Summary for Generic Name: octreotide acetate

Drug Master File Entries: see list14
Suppliers / Packaging: see list17
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)

Pharmacology for Ingredient: octreotide acetate

Clinical Trials for: octreotide acetate

Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
Status: Completed Condition: Acromegaly

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

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor
Status: Active, not recruiting Condition: Neuroendocrine Carcinoma

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds
octreotide acetate
INJECTABLE;INJECTION077372-003Aug 14, 2007RXNo<disabled><disabled>
octreotide acetate
INJECTABLE;INJECTION021008-002Nov 25, 1998RXNo5,922,682*PED<disabled>Y<disabled>
Eurohlth Intl Sarl
octreotide acetate
INJECTABLE;INJECTION076313-002Mar 28, 2005RXYes<disabled><disabled>
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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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