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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)
Formulation / Manufacturing:see details

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

Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma
Status: Active, not recruiting Condition: Gastrin-Producing Neuroendocrine Tumor; Lung Carcinoid Tumor; Metastatic Digestive System Neuroendocrine Tumor G1; Pancreatic Glucagonoma; Pancreatic Insulinoma; Pancreatic Polypeptide Tumor; Paraganglioma; Recurrent Digestive System Neuroendocrine Tumor G1; Recurrent Merkel Cell Carcinoma; Recurrent Pancreatic Neuroendocrine Carcinoma; Regional Digestive System Neuroendocrine Tumor G1; Somatostatin-Producing Neuroendocrine Tumor; Stage III Merkel Cell Carcinoma; Stage IV Merkel Cell Carcinoma; Thyroid Gland Medullary Carcinoma

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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
Fresenius Kabi Usa
octreotide acetate
INJECTABLE;INJECTION077450-001Feb 10, 2006RXNo<disabled><disabled>
Mylan Institutional
octreotide acetate
INJECTABLE;INJECTION079198-003Feb 10, 2011RXNo<disabled><disabled>
Sun Pharm Inds
octreotide acetate
INJECTABLE;INJECTION077329-001Mar 4, 2008RXNo<disabled><disabled>
Fresenius Kabi Usa
octreotide acetate
INJECTABLE;INJECTION077457-002Feb 10, 2006RXNo<disabled><disabled>
Sun Pharm Inds
octreotide acetate
INJECTABLE;INJECTION077372-002Aug 14, 2007RXNo<disabled><disabled>
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Preferred citation:

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

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