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
Cytogen Corporation	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	4,898,724

International Patents for QUADRAMET

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

Country	Patent Number	Title	Estimated Expiration
Egypt	19250	Method for purifying aminomethylenephosphonics acids.
Mexico	9203064	COMPLEJOS DE ACIDO AMINOFOSFONICO ORGANICO PARA EL TRATAMIENTO DE TUMORES CALCIFICADOS.
Spain	2090105
South Korea	100178877

Supplementary Protection Certificates for QUADRAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0513917	98C0018	Netherlands		PRODUCT NAME: SAMARIUM LEXIDRONAM PENTASODIQUE; NAT. REGISTRATION NO/DATE: EU/1/97/057/001 19980205; FIRST REGISTRATION: CH - 54265 19971006
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
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	98C0023	Belgium		PRODUCT NAME: SAMARIUM (153 SM) LEXIDRONAM PENTASODIQUE; NAT. REGISTRATION NO/DATE: EU/1/97/057/001 19980205; FIRST REGISTRATION: CH 54265 19971006

QUADRAMET Market Analysis and Financial Projection

Last updated: February 17, 2026

What Are the Market Dynamics for QUADRAMET?

Market Position and Usage

QUADRAMET (samarium Sm-153 lexidronam) is a radiopharmaceutical approved to treat pain from bone metastases in patients with cancer. The drug is primarily used in nuclear medicine for its targeted radiotherapy, which alleviates pain in advanced cancer cases, especially prostate, breast, and lung cancers.

Competitor Landscape

The primary competitor is Radium-223 (Xofigo), which is FDA-approved for prostate cancer with bone metastases. Unlike QUADRAMET, Radium-223 is a standalone therapy that improves overall survival, giving it an advanced position in the market. Other radiopharmaceuticals like Strontium-89 (Metastron) maintain niche status but have declined due to limited efficacy and safety concerns.

Key Market Drivers

• Growing prevalence of bone metastases: Estimated 200,000 new cases of bone metastases annually in the U.S. alone. The global cancer incidence is projected to reach 28.4 million new cases annually by 2040 ([1]).

• Adoption of radiopharmaceuticals: Increased acceptance in palliative care for metastatic bone pain. Advances in imaging and delivery techniques improve adoption.

• Expanding approval scope: Use in multiple cancers and potential off-label applications expand market size.

Market Limitations

• Limited indications: Approved only for bone pain palliation, restricting revenue potential.

• Competition from newer agents: Radium-223’s survival benefit and emerging targeted therapies reduce QUADRAMET’s relative market share.

• Regulatory and reimbursement challenges: Navigating complex approval and reimbursement processes impacts market penetration.

Regional Dynamics

North America accounts for approximately 60% of the global market, driven by high cancer prevalence and advanced healthcare infrastructure. Europe follows with about 25%. Asia-Pacific presents growth opportunities due to increasing cancer burden and expanding nuclear medicine facilities.

---

What Is the Financial Trajectory for QUADRAMET?

Revenue Analysis

Since its launch in 1997, QUADRAMET has experienced a gradual decline in sales amid market shifts. In the U.S., annual sales averaged approximately $30 million between 2010 and 2015. Post-2015, sales declined to roughly $10 million annually, attributed to new competitors and limited indications ([2]).

Market Share Trends

• In 2010, QUADRAMET captured nearly 80% of the radiopharmaceutical niche for bone pain palliation.

• By 2020, its market share dropped to below 20%, with Radium-223 dominating the segment for advanced prostate cancer.

Financial Challenges

The drug's revenue faces constraints from patent expirations (though the original patent expired in 2015), reduced market penetration, and competition from more efficacious or wider-indication therapies.

Cost of Production and Pricing

• Wholesale acquisition cost (WAC): Approximately $1,200 per dose.

• Cost structure includes radioisotope procurement, specialized manufacturing, and distribution logistics.

• Pricing strategies remain cautious due to reimbursement pressures and competition.

Future Financial Outlook

The global radiopharmaceuticals market is valued at approximately $8.4 billion in 2022, with an expected compound annual growth rate (CAGR) of 8.4% through 2030 ([3]). However, specific for QUADRAMET, revenue is projected to decline further unless:

• New indications are approved.

• It gains market share through collaborations or regulatory incentives.

• Cost reduction efforts improve profitability.

Potential for Lifecycle Extension

Development of combination therapies, new cancer indications, or adjunctive use may expand the market. Regulatory pathways for using QUADRAMET in different cancers or in combination with other therapies have not yet been fully explored.

---

Key Takeaways

• QUADRAMET's market has contracted, especially with the rise of Radium-223 and other advanced radiotherapies.

• The drug’s primary value remains in palliation of bone pain in metastatic cancer, with limited expansion avenues.

• Revenue declines are expected unless new indications or market strategies are implemented.

• The global radiopharmaceutical sector is expanding, but QUADRAMET’s isolated position limits its growth potential.

• Regulatory and reimbursement constraints hinder market expansion despite its established safety and efficacy profile.

---

FAQs

1. Can QUADRAMET be used for cancers other than prostate, breast, and lung?
Currently, approvals limit its use to palliation of bone pain in various metastatic cancers; off-label applications are unapproved and not recommended without further clinical evidence.

2. Are there ongoing clinical trials for expanding QUADRAMET’s indications?
No significant late-stage trials have publicly announced development for new indications. Future research may focus on combination therapies or novel cancers.

3. How does the safety profile of QUADRAMET compare to newer therapies?
QUADRAMET generally has a favorable safety profile with transient hematologic adverse effects; newer agents like Radium-223 also show similar or improved safety, influencing market competition.

4. What is the impact of patent expiration on QUADRAMET?
Patent expiry in 2015 led to generic competition, exerting downward pressure on prices and sales.

5. What are the reimbursement prospects for QUADRAMET?
Reimbursements are stable in the U.S. but face challenges internationally due to differing healthcare policies and the availability of alternative treatments.

---

References

[1] American Cancer Society, "Cancer Facts & Figures 2022," https://www.cancer.org/research/cancer-facts-and-statistics.html
[2] IQVIA, "Pharmaceutical Market Reports," 2022.
[3] Allied Market Research, "Radiopharmaceuticals Market by Type and Application," 2022.