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Last Updated: December 23, 2024

SAMARIUM SM-153 LEXIDRONAM PENTASODIUM - Generic Drug Details


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What are the generic sources for samarium sm-153 lexidronam pentasodium and what is the scope of freedom to operate?

Samarium sm-153 lexidronam pentasodium is the generic ingredient in one branded drug marketed by Lantheus Medical and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 6
DailyMed Link:SAMARIUM SM-153 LEXIDRONAM PENTASODIUM at DailyMed
Recent Clinical Trials for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Phase 3
Radiation Therapy Oncology GroupPhase 3
NRG OncologyPhase 3

See all SAMARIUM SM-153 LEXIDRONAM PENTASODIUM clinical trials

US Patents and Regulatory Information for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lantheus Medical QUADRAMET samarium sm-153 lexidronam pentasodium INJECTABLE;INJECTION 020570-001 Mar 28, 1997 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SAMARIUM SM-153 LEXIDRONAM PENTASODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Samarium Sm-153 Lexidronam Pentasodium

Introduction

Samarium Sm-153 lexidronam pentasodium, commonly known by its brand name Quadramet, is a radiopharmaceutical used to alleviate bone pain associated with certain types of cancer, particularly those with osteoblastic metastatic bone lesions. Here, we delve into the market dynamics and financial trajectory of this drug.

Therapeutic Indications and Market Need

Samarium Sm-153 lexidronam pentasodium is specifically designed to target areas of high bone turnover, such as sites of metastases, providing relief from bone pain caused by cancer. The drug's ability to concentrate in these areas and deliver localized radiation makes it a valuable treatment option for patients with advanced cancer[4][5].

Market Size and Growth

The market for radiopharmaceuticals, including Samarium Sm-153 lexidronam pentasodium, has been growing due to the increasing incidence of cancer and the need for effective pain management. The global radiopharmaceutical market is expected to expand, driven by advancements in nuclear medicine and the rising demand for targeted therapies.

Competitive Landscape

The radiopharmaceutical market is competitive, with several other drugs and therapies available for managing bone pain in cancer patients. However, Samarium Sm-153 lexidronam pentasodium holds a unique position due to its specific mechanism of action and targeted delivery of radiation to bone metastases. Competitors include other radiopharmaceuticals and non-radioactive treatments, but Quadramet's efficacy and safety profile have established it as a preferred option in many clinical settings[3][4].

Regulatory and Approval Status

Samarium Sm-153 lexidronam pentasodium was first approved by the FDA in 1997 for the treatment of bone pain associated with osteoblastic metastatic bone lesions. Since its approval, it has undergone various clinical trials to expand its indications, including phase II trials for multiple myeloma and prostate cancer[2][3].

Pricing and Reimbursement

The pricing of Samarium Sm-153 lexidronam pentasodium can vary based on regional healthcare policies and reimbursement structures. In general, radiopharmaceuticals are often covered by insurance and government healthcare programs due to their specialized nature and the critical need they fulfill in cancer treatment. The cost of Quadramet is significant, but it is often justified by its effectiveness in providing pain relief and improving the quality of life for patients with advanced cancer[3].

Clinical Trials and Development

Ongoing and completed clinical trials have played a crucial role in the market dynamics of Samarium Sm-153 lexidronam pentasodium. Trials have focused on expanding its use to other types of cancer, such as breast cancer and lung cancer, and exploring combination therapies to enhance its efficacy. These efforts continue to support the drug's market position and potential for future growth[2][3].

Financial Performance

The financial performance of Samarium Sm-153 lexidronam pentasodium is influenced by several factors, including sales volume, pricing, and competition. As a specialized radiopharmaceutical, it generates significant revenue due to its high demand and limited alternatives. The drug's manufacturer and distributors have seen steady revenue streams, although exact financial figures are not publicly disclosed.

Key Players and Partnerships

The development and marketing of Samarium Sm-153 lexidronam pentasodium involve several key players, including the original developer, Dow Chemical Company, and current manufacturers and distributors. Partnerships with research institutions, such as the M.D. Anderson Cancer Center, have been crucial in advancing the drug's clinical trials and expanding its indications[3].

Challenges and Opportunities

Despite its success, the market for Samarium Sm-153 lexidronam pentasodium faces challenges such as regulatory hurdles, competition from emerging therapies, and the need for continuous clinical validation. However, opportunities exist in expanding its use to new indications, developing combination therapies, and improving patient access through better reimbursement policies.

Patient Access and Healthcare Policy

Patient access to Samarium Sm-153 lexidronam pentasodium is influenced by healthcare policies and reimbursement structures. Efforts to improve access, such as advocacy for better insurance coverage and government support, are ongoing. Healthcare providers and patient advocacy groups play a significant role in ensuring that this critical treatment is available to those who need it.

Future Outlook

The future outlook for Samarium Sm-153 lexidronam pentasodium is positive, driven by ongoing research, expanding indications, and the growing need for effective cancer pain management. As the global healthcare landscape continues to evolve, this drug is likely to remain a valuable option for patients suffering from bone pain associated with cancer.

Key Takeaways

  • Therapeutic Indications: Samarium Sm-153 lexidronam pentasodium is used to relieve bone pain in cancer patients with osteoblastic metastatic bone lesions.
  • Market Growth: The radiopharmaceutical market is growing, driven by the increasing incidence of cancer and advancements in nuclear medicine.
  • Competitive Landscape: Quadramet holds a unique position due to its targeted delivery of radiation to bone metastases.
  • Regulatory Status: Approved by the FDA in 1997 with ongoing clinical trials to expand its indications.
  • Financial Performance: Generates significant revenue due to its high demand and limited alternatives.
  • Challenges and Opportunities: Faces regulatory hurdles and competition but has opportunities in new indications and combination therapies.

FAQs

What is Samarium Sm-153 lexidronam pentasodium used for?

Samarium Sm-153 lexidronam pentasodium, known by its brand name Quadramet, is used to help relieve bone pain that may occur with certain kinds of cancer, particularly those with osteoblastic metastatic bone lesions[4][5].

How does Samarium Sm-153 lexidronam pentasodium work?

The drug concentrates in areas of high bone turnover, such as sites of metastases, and delivers localized radiation to provide relief from bone pain[4][5].

Who can administer Samarium Sm-153 lexidronam pentasodium?

This product is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine or radiation oncology[5].

What are the potential side effects of Samarium Sm-153 lexidronam pentasodium?

The drug can temporarily lower the number of white blood cells and platelets, increasing the chance of infection and bleeding[5].

Is Samarium Sm-153 lexidronam pentasodium covered by insurance?

Yes, it is often covered by insurance and government healthcare programs due to its specialized nature and critical need in cancer treatment[3].

References

  1. QUADRAMET - accessdata.fda.gov
  2. SAMARIUM SM-153 LEXIDRONAM PENTASODIUM - synapse.patsnap.com
  3. Samarium 153 lexidronam - AdisInsight - Springer
  4. Samarium (153Sm) lexidronam: Uses, Interactions - DrugBank
  5. Samarium sm 153 lexidronam (intravenous route) - Mayo Clinic

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