Teva Announces Launch of the First and Only Generic Version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension), in the U.S.
Teva Pharmaceuticals has launched the first and only generic version of Sandostatin® LAR Depot (octreotide acetate for injectable suspension) in the United States. This medication is used to treat acromegaly and severe diarrhea associated with carcinoid syndrome. The launch demonstrates Teva's expertise in complex generic formulations and supports its goal of maintaining a strong position in the generics market.
Octreotide acetate for injectable suspension is indicated for long-term maintenance therapy in acromegalic patients and for the long-term treatment of severe diarrhea and flushing episodes related to metastatic carcinoid tumors and VIP-secreting tumors. The annual sales of Sandostatin® LAR Depot were $826 million as of July 2024, according to IQVIA data.
Teva Pharmaceuticals ha lanciato la prima e unica versione generica di Sandostatin® LAR Depot (acetato di octreotide per sospensione iniettabile) negli Stati Uniti. Questo farmaco è utilizzato per trattare l'acromegalia e la diarrea grave associata alla sindrome carcinoide. Il lancio dimostra l'esperienza di Teva nelle formulazioni generiche complesse e supporta il suo obiettivo di mantenere una posizione forte nel mercato dei generici.
L'acetato di octreotide per sospensione iniettabile è indicato per la terapia di mantenimento a lungo termine nei pazienti acromegalici e per il trattamento a lungo termine della diarrea grave e degli episodi di arrossamento legati ai tumori carcinoidi metastatici e ai tumori VIP-secreting. Le vendite annuali di Sandostatin® LAR Depot ammontavano a 826 milioni di dollari a luglio 2024, secondo i dati di IQVIA.
Teva Pharmaceuticals ha lanzado la primera y única versión genérica de Sandostatin® LAR Depot (acetato de octreotido para suspensión inyectable) en los Estados Unidos. Este medicamento se utiliza para tratar la acromegalia y la diarrea severa asociada con el síndrome carcinoide. El lanzamiento demuestra la experiencia de Teva en formulaciones genéricas complejas y apoya su objetivo de mantener una posición fuerte en el mercado de genéricos.
El acetato de octreotido para suspensión inyectable está indicado para la terapia de mantenimiento a largo plazo en pacientes acromegálicos y para el tratamiento a largo plazo de episodios severos de diarrea y rubor relacionados con tumores carcinoides metastásicos y tumores secretantes de VIP. Las ventas anuales de Sandostatin® LAR Depot eran de 826 millones de dólares a julio de 2024, según datos de IQVIA.
Teva Pharmaceuticals는 미국에서 Sandostatin® LAR Depot (주사 가능한 옥트레오타이드 아세테이트)의 첫 번째이자 유일한 제네릭 버전을 출시했습니다. 이 약물은 거인증 및 악성 신경내분비 종양 증후군과 관련된 심한 설사를 치료하는 데 사용됩니다. 이번 출시는 복잡한 제네릭 제형에 대한 Teva의 전문성을 입증하며, 제네릭 시장에서 강력한 입지를 유지하겠다는 목표를 지원합니다.
주사 가능한 옥트레오타이드 아세테이트는 거인증 환자를 위한 장기 유지 요법과 전이성 신경내분비 종양 및 VIP 분비 종양과 관련된 심한 설사 및 홍조 에피소드를 위한 장기 치료에 적응증이 있습니다. Sandostatin® LAR Depot의 연간 매출은 2024년 7월 기준으로 8억 2600만 달러에 달한다고 IQVIA의 데이터에 따르면.
Teva Pharmaceuticals a lancé la première et unique version générique de Sandostatin® LAR Depot (acétate d'octréotide pour suspension injectable) aux États-Unis. Ce médicament est utilisé pour traiter l'acromégalie et la diarrhée sévère associée au syndrome carcinoïde. Le lancement démontre l'expertise de Teva dans les formulations génériques complexes et soutient son objectif de maintenir une position forte sur le marché des génériques.
L'acétate d'octréotide pour suspension injectable est indiqué pour la thérapie d'entretien à long terme chez les patients acromégales et pour le traitement à long terme de la diarrhée sévère et des épisodes de bouffées vasomotrices liés aux tumeurs carcinoïdes métastatiques et aux tumeurs sécrétant VIP. Les ventes annuelles de Sandostatin® LAR Depot s'élevaient à 826 millions de dollars en juillet 2024, selon les données de IQVIA.
Teva Pharmaceuticals hat die erste und einzige generische Version von Sandostatin® LAR Depot (Octreotidacetat zur Injektionssuspension) in den USA auf den Markt gebracht. Dieses Medikament wird zur Behandlung von Akromegalie und schweren Durchfällen eingesetzt, die mit dem Karzinoidsyndrom verbunden sind. Der Launch zeigt Tevas Expertise in komplexen generischen Formulierungen und unterstützt das Ziel, eine starke Position im Generikamedizin-Markt zu halten.
Octreotidacetat zur Injektionssuspension ist für die langfristige Erhaltungstherapie bei akromegalen Patienten und für die langfristige Behandlung von schweren Durchfällen und Flush-Episoden, die mit metastatischen Karzinoidtumoren und VIP-sezernierenden Tumoren verbunden sind, angezeigt. Der Jahresumsatz von Sandostatin® LAR Depot betrug laut Daten von IQVIA im Juli 2024 826 Millionen US-Dollar.
- First-to-market launch of a generic version of Sandostatin® LAR Depot
- Demonstrates Teva's expertise in complex generic formulations
- Supports Teva's goal of maintaining a strong position in the generics market
- Provides a new treatment option for patients
- Targets a product with annual sales of $826 million
- None.
Insights
The launch of the first generic version of Sandostatin® LAR Depot is a significant milestone for Teva Pharmaceuticals. This move strengthens Teva's position in the complex generics market and aligns with their strategy to maintain a strong generics portfolio. The original brand, Sandostatin® LAR Depot, had annual sales of
This first-to-market advantage could potentially capture a significant portion of that market, boosting Teva's revenue stream. The launch demonstrates Teva's capabilities in developing complex formulations, which typically face less competition and offer higher profit margins compared to simple generics. This could positively impact Teva's financial performance in the coming quarters.
Investors should monitor the uptake of this generic version and its impact on Teva's revenue and market share in the coming months. The success of this launch could also pave the way for similar high-value generic introductions in the future, potentially improving Teva's long-term growth prospects in the competitive generics market.
Teva's launch of the first generic version of Sandostatin® LAR Depot is a significant development for patients with acromegaly and carcinoid syndrome. This long-acting formulation of octreotide acetate addresses critical medical needs:
- For acromegaly patients, it provides a more accessible option for long-term maintenance therapy, especially for those who have had inadequate responses to surgery or radiotherapy.
- For patients with carcinoid tumors, it offers a new treatment option for managing severe diarrhea and flushing episodes.
- The generic version could potentially improve patient access and adherence due to lower costs.
However, it's important to note that the effect on tumor size, growth rate and metastasis development hasn't been determined for carcinoid and VIP-secreting tumors. The safety profile appears similar to the branded version, with key considerations including potential impacts on gallbladder function, sugar metabolism and thyroid function. The availability of this generic could significantly impact treatment patterns and patient outcomes in these therapeutic areas.
- This first-to-market launch showcases Teva’s proven strengths in complex generic formulations and enhances Teva’s strategic goal of sustaining a generic powerhouse.
- Octreotide acetate for injectable suspension is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome.
PARSIPPANY, N.J., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of the first and only generic version of Sandostatin®1 LAR Depot, in the United States.
Octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot) is indicated to treat acromegaly and severe diarrhea for carcinoid syndrome. Please see the below for more information.
“With today’s launch of octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot), Teva is providing patients a new option for this important treatment,” said Ernie Richardsen, SVP U.S. Commercial Generics.” He continued, “This first-to-market launch showcases Teva’s expertise in bringing complex generic formulations to market and demonstrates once again our ability to not only sustain a generics powerhouse, but also to bring value to patients and healthcare systems.”
Sandostatin® LAR Depot had annual sales of
What is octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)?
Octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot) is a prescription medication used in patients in whom initial treatment with octreotide acetate injection has been shown to be effective and tolerated for:
- Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option to reduce GH and IGF-1 levels to normal.
- Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
- Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors.
In patients with carcinoid tumors and VIP-secreting tumors, the effect of octreotide acetate injection and octreotide acetate for injectable suspension on tumor size, rate of growth and development of metastases, has not been determined.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)?
Treatment with octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot) may affect gallbladder function, with reports of gallstones resulting in complications (inflammation of the gallbladder, bile duct, and pancreas, and requiring surgical removal of the gallbladder); sugar metabolism; thyroid and heart function; and nutritional absorption, which may require monitoring by your doctor. Tell your doctor if you experience signs or symptoms of gallstones or any of their complications.
Patients with carcinoid tumors and VIP-secreting tumors should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms.
Patients with acromegaly should adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels.
What should I tell my doctor before taking octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)?
Tell your doctor if you have a history of heart disease or are taking other medications, including cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.
What are the possible side effects of octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot)?
In acromegalic patients, the most common side effects of octreotide acetate for injectable suspension include gallstones, diarrhea, abdominal pain, gas, flu-like symptoms, constipation, headache, low red blood cells, injection-site pain, gallstones, high blood pressure, dizziness and fatigue.
In carcinoid tumor and VIP-secreting tumor patients, the most common side effects of octreotide acetate for injectable suspension include back pain, fatigue, headache, abdominal pain, nausea, and dizziness.
These are not all of the possible side effects of octreotide acetate for injectable suspension. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: the launch and commercial success of octreotide acetate for injectable suspension (the generic version of Sandostatin® LAR Depot); our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; concentration of our customer base and commercial alliances among our customers; delays in launches of new generic products; our ability to develop and commercialize biopharmaceutical products; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to sustain and focus our portfolio of generics medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
1 Sandostatin® LAR Depot is a registered trademark of Novartis AG.
| IR Contacts | United States | Ran Meir | (215) 591-8912 |
| Sanjeev Sharma | (973) 658 2700 | ||
| PR Contacts | United States | Kelley Dougherty | (973) 658-0237 |
| Yonatan Beker | (973) 264 7378 | ||
| Israel | Eden Klein | 972 (3) 906-2645 |
FAQ
What is the generic version of Sandostatin® LAR Depot launched by Teva (TEVA)?
What conditions does Teva's (TEVA) new generic drug treat?
What were the annual sales of Sandostatin® LAR Depot before Teva's (TEVA) generic launch?
How does this launch align with Teva's (TEVA) business strategy?
