QUADRAMET Drug Patent Profile

Which patents cover Quadramet, and what generic alternatives are available?

Quadramet is a drug marketed by Lantheus Medical and is included in one NDA.

The generic ingredient in QUADRAMET is samarium sm-153 lexidronam pentasodium. Additional details are available on the samarium sm-153 lexidronam pentasodium profile page.

Summary for QUADRAMET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	3
Drug Prices:	Drug price information for QUADRAMET
What excipients (inactive ingredients) are in QUADRAMET?	QUADRAMET excipients list
DailyMed Link:	QUADRAMET at DailyMed

See drug prices for QUADRAMET

Recent Clinical Trials for QUADRAMET

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1/Phase 2
Mayo Clinic	Phase 1/Phase 2
Sidney Kimmel Cancer Center at Thomas Jefferson University	Phase 1

See all QUADRAMET clinical trials

US Patents and Regulatory Information for QUADRAMET

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

Expired US Patents for QUADRAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medical	QUADRAMET	samarium sm-153 lexidronam pentasodium	INJECTABLE;INJECTION	020570-001	Mar 28, 1997

International Patents for QUADRAMET

See the table below for patents covering QUADRAMET around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0408701	COMPLEXES D'ACIDES AMINOPHOSPHONIQUES MACROCYCLIQUES DE TRAITEMENT DE TUMEURS CALCIFIANTES. (MACROCYCLIC AMINOPHOSPHONIC ACID COMPLEXES, THEIR PREPARATION, FORMULATIONS AND USE.)
Japan	2922263
Japan	H0366697	PURIFICATION OF AMINOMETHYLENE PHOSPHONIC ACID
Israel	92784	Pharmaceutical compositions of macrocyclic aminophosphonic acid complexes containing tetraazacyclododecane and radionuclides and their preparation
Romania	105967	PROCEDEU PENTRU PURIFICAREA ACIDULUI ETILENDIAMINIO-tetra-(METILENFOSFONIC) SI A ACIDULUI 1,4,7,10-tetra-AZACICLODODECAN-1,4,7,10-tetra (METILENFOSFONIC) (PURIFICATION PROCESS FOR ETHYLENEDIAMINIO--TETRA-CMETHYLENE PHOSPHONIC ACID AND FOR 1,4,7,10-TETRA-AZACYCLODODECAN-1,4,7,10-TETRA)
World Intellectual Property Organization (WIPO)	9006776

Supplementary Protection Certificates for QUADRAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0164843	SPC/GB98/028	United Kingdom		PRODUCT NAME: 153 SAMARIUM ETHYLENEDIAMINETETRAMETHYLENEPHOSPHONIC ACID (QUADRAMET); REGISTERED: CH CH 54265 19971006; UK EU/1/97/057/001 19980205
0164843	C980021	Netherlands		PRODUCT NAME: SAMARIUM[153 SM] LEXIDRONAM, DESGEWENST IN DE VORM VAN EEN FYSI OLOGISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET PENTANATRIUMZO UT; NAT.REGISTRATION NO/DATE: C(1998)253 DEF 19980205; FIRST REGISRATION: EU/1/97/057/001 19980205
0513917	98C0018	Netherlands		PRODUCT NAME: SAMARIUM LEXIDRONAM PENTASODIQUE; NAT. REGISTRATION NO/DATE: EU/1/97/057/001 19980205; FIRST REGISTRATION: CH - 54265 19971006
0164843	98C0023	Belgium		PRODUCT NAME: SAMARIUM (153 SM) LEXIDRONAM PENTASODIQUE; NAT. REGISTRATION NO/DATE: EU/1/97/057/001 19980205; FIRST REGISTRATION: CH 54265 19971006

Market Dynamics and Financial Trajectory for QUADRAMET

Last updated: July 28, 2025

Introduction

QUADRAMET, commercially known as Samarium-153 lexidronam, is a targeted radiopharmaceutical indicated primarily for palliative treatment of painful bone metastases associated with prostate, breast, and other cancers. Since its approval, QUADRAMET has played a niche but vital role within the broader oncology therapeutics and radiopharmaceutical market. This analysis explores the evolving market dynamics, competitive landscape, regulatory considerations, and financial trajectory associated with QUADRAMET.

Market Overview

Therapeutic Context

Cancer-induced bone metastases afflict approximately 70% of patients with advanced prostate and breast cancers, significantly impairing quality of life due to pain and skeletal-related events (SREs) [1]. Radiopharmaceuticals like QUADRAMET target bone metastases, delivering localized radiation therapy with a focus on palliation rather than curative intent. The evolving standard of care emphasizes symptom management, posing a steady demand for such treatments.

Market Size and Growth

The global radiopharmaceuticals market valuation was estimated at USD 5.8 billion in 2022 and projected to expand at a CAGR of approximately 8% through 2030 [2]. Within this, the segment for bone-targeting radiopharmaceuticals—comprising agents like QUADRAMET, radium-223 dichloride (Xofigo), and strontium-89—accounts for a significant share due to the high prevalence of bone metastases.

Segment Specifics

QUADRAMET's niche positioning results from its favorable safety profile, ease of administration, and established efficacy. However, competition from newer agents like radium-223, which offers survival benefits beyond palliation, influences its market share.

Market Dynamics

Drivers

• Prevalence of Bone Metastases: Rising incidences of advanced prostate and breast cancers drive demand for supportive therapies such as QUADRAMET.
• Approvals and Label Expansion: Regulatory endorsements that expand indication scope enhance market penetration.
• Physician Acceptance: Growing familiarity with radiopharmaceuticals, driven by clinical studies demonstrating palliation efficacy, fosters adoption.
• Advances in Radiochemistry and Delivery: Technological developments that improve targeting and reduce side effects bolster QUADRAMET's market appeal.

Challenges

• Intense Competition: Radium-223 (Xofigo) has gained prominence due to its survival benefits and broader approval for castration-resistant prostate cancer (CRPC) with bone metastases [3].
• Limited Indications: QUADRAMET’s primary approval for bone pain palliation limits its use compared to multi-purpose agents.
• Reimbursement and Cost Constraints: Variations in healthcare policies impact access and affordability.
• Manufacturing Complexities: The production of Samarium-153 necessitates specialized facilities, influencing supply reliability and costs.

Regulatory and Reimbursement Landscape

Stringent regulatory pathways for radiopharmaceuticals, including safety, manufacturing, and efficacy standards, shape market acceptance. Reimbursement policies vary globally, influencing adoption rates significantly, especially in emerging markets.

Technological and Scientific Trends

Innovations in alpha-emitting radiopharmaceuticals and combination therapies are poised to reshape the landscape. For QUADRAMET, integrating with systemic treatments or improving delivery methods could provide competitive advantages.

Financial Trajectory

Revenue Streams and Market Penetration

Historically, QUADRAMET’s sales have been driven primarily by mature markets like North America and Western Europe. Limited direct competition for its specific indication and established use contribute to steady revenues. However, the advent of alternative therapies like radium-223 has begun to encroach upon this domain, leading to stagnation in growth for some manufacturers.

Pricing and Cost Dynamics

Radiopharmaceuticals often command premium pricing due to manufacturing complexities and targeted therapy benefits. Nonetheless, pricing pressures and reimbursement negotiations influence profitability. The high cost associated with isotope production, regulatory compliance, and distribution logistics further impact margins.

Future Growth Potential

Potential growth avenues include:

• Indication Expansion: Pursuing approvals for broader labels or combination indications.
• Market Expansion: Increasing access in emerging markets with rising cancer burdens.
• Manufacturing Innovations: Improving potency and reducing costs through technological advancements.
• Strategic Partnerships: Collaborations with oncology and nuclear medicine stakeholders to integrate QUADRAMET into multimodal treatment protocols.

Impact of Competitive Dynamics

The presence of alternative radiopharmaceuticals and evolving treatment paradigms influence QUADRAMET's financial trajectory. While current revenues remain stable in mature markets, growth prospects hinge on strategic repositioning and innovation.

Regulatory and Patent Considerations

Although key patents covering Samarium-153 have expired or are nearing expiration, optimizing manufacturing processes and securing new approvals can sustain market viability. Regulatory approval in non-traditional markets could create incremental revenues.

Conclusion

The financial trajectory of QUADRAMET is characterized by stability in established markets with moderate growth prospects. Competition from newer agents, evolving treatment standards, and healthcare system dynamics pose challenges but also open opportunities through innovation, indication expansion, and strategic collaborations. Overall, QUADRAMET occupies a niche space within the radiopharmaceutical landscape, with a steady demand driven by its proven palliative efficacy.

Key Takeaways

1. Steady Demand Amid Competition: QUADRAMET remains a vital palliation agent for bone metastases, although recent competition impacts growth.
2. Growth Opportunities in Emerging Markets: Expanding access and approvals in developing regions could bolster revenues.
3. Innovation and Combination Therapies: Incorporating QUADRAMET into multimodal treatments may enhance its clinical and commercial value.
4. Regulatory Navigation: Staying ahead with regulatory clearances and indications will be crucial for sustained growth.
5. Cost Management and Manufacturing Efficiency: Enhancing production efficiencies can improve margins amidst pricing pressures.

FAQs

1. What distinguishes QUADRAMET from other radiopharmaceuticals?
QUADRAMET delivers localized radiation specifically targeting bone metastases, with a well-established safety profile and straightforward administration, making it a preferred choice for palliation over some newer agents that offer survival benefits.

2. How has the emergence of radium-223 affected QUADRAMET's market?
Radium-223 (Xofigo) has expanded treatment options, particularly offering survival advantages in prostate cancer with bone metastases. This has slightly diminished QUADRAMET’s market share but also opened avenues for combination and sequential therapies.

3. What are the primary challenges facing QUADRAMET’s growth?
The main challenges include limited indications confined mainly to palliation, competition from newer agents with claimed survival benefits, manufacturing complexities, and reimbursement issues.

4. What strategies can enhance QUADRAMET’s market penetration?
Strategies include seeking expanded indications, fostering physician awareness, entering emerging markets, improving manufacturing efficiencies, and developing combination therapy protocols.

5. What is the outlook for QUADRAMET’s revenue in the next five years?
Given current market dynamics, revenue is expected to stabilize in mature markets but could grow modestly through expanded approvals, emerging market penetration, and strategic collaborations, provided manufacturers adapt to evolving competitive and regulatory environments.

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References

[1] Coleman RE. Clinical features of metastatic bone disease. Oncology. 1997.
[2] Grand View Research. (2022). Radiopharmaceuticals Market Size, Share & Trends Analysis.
[3] Smith M, et al. Radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013.