Teva Launches First Generic Version of Sandostatin® LAR Depot in the U.S.

Teva Pharmaceuticals, the U.S. branch of Teva Pharmaceutical Industries Ltd., has announced the introduction of the first and only generic version of Sandostatin® LAR Depot in the United States. This new generic product, octreotide acetate for injectable suspension, is designed to address conditions such as acromegaly and severe diarrhea associated with carcinoid syndrome.

Ernie Richardsen, SVP of U.S. Commercial Generics at Teva, emphasized the significance of this launch, stating, "By introducing octreotide acetate for injectable suspension, Teva is offering patients an important new treatment option. This launch highlights Teva’s expertise in developing complex generic formulations and reinforces our commitment to maintaining our status as a generics powerhouse. It also underscores our efforts to deliver value to both patients and healthcare systems."

According to IQVIA data, Sandostatin® LAR Depot achieved annual sales of $826 million as of July 2024. The introduction of its generic counterpart by Teva is expected to have a substantial impact on the market.

Octreotide acetate for injectable suspension is a prescription medication for patients who have responded well to initial treatment with octreotide acetate injection. It is intended for long-term maintenance therapy in acromegalic patients who have not adequately responded to surgery or radiotherapy, or for whom these treatments are not viable options. Additionally, it is used for the long-term management of severe diarrhea and flushing episodes related to metastatic carcinoid tumors, as well as for the treatment of profuse watery diarrhea associated with VIP-secreting tumors.

It is important to note that the impact of octreotide acetate injection and octreotide acetate for injectable suspension on the size, growth rate, and development of metastases in patients with carcinoid and VIP-secreting tumors has not been determined.

Patients should be aware of the potential safety concerns associated with octreotide acetate for injectable suspension. Treatment may affect gallbladder function, leading to complications such as gallstones, inflammation, and potentially requiring surgical intervention. It may also impact sugar metabolism, thyroid and heart function, and nutritional absorption, necessitating monitoring by healthcare providers. Patients with carcinoid and VIP-secreting tumors should adhere to scheduled reinjection visits to minimize symptom exacerbation, while those with acromegaly should follow their return visit schedules to maintain control of GH and IGF-1 levels.

Before starting treatment with octreotide acetate for injectable suspension, patients should inform their doctors of any history of heart disease or if they are taking medications such as cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, or bromocriptine. Common side effects in acromegalic patients include gallstones, diarrhea, abdominal pain, gas, flu-like symptoms, constipation, headache, low red blood cells, injection-site pain, high blood pressure, dizziness, and fatigue. For patients with carcinoid and VIP-secreting tumors, typical side effects include back pain, fatigue, headache, abdominal pain, nausea, and dizziness. Patients are encouraged to report any adverse effects to their healthcare provider or the FDA.

Teva Pharmaceutical Industries Ltd. is a global leader in the pharmaceutical industry, with a diverse portfolio that integrates generics expertise and innovative approaches to modern medicine. With a history spanning over 120 years, Teva is committed to advancing healthcare and improving the health outcomes of millions of patients worldwide. The company’s extensive global network, comprising approximately 37,000 employees in 58 markets, continues to drive scientific innovation and deliver quality medicines.

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