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
Mayo Clinic	Phase 1/Phase 2
National Cancer Institute (NCI)	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
South Korea	0178966
Australia	4122985
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)
Australia	639899
South Korea	100178877

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	98C0023	Belgium		PRODUCT NAME: SAMARIUM (153 SM) LEXIDRONAM PENTASODIQUE; NAT. REGISTRATION NO/DATE: EU/1/97/057/001 19980205; FIRST REGISTRATION: CH 54265 19971006
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

QUADRAMET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Quadramet

Introduction

Quadramet, also known as samarium Sm-153 lexidronam injection, is a radiopharmaceutical approved for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions. Here, we delve into the market dynamics and financial trajectory of this drug.

Indications and Usage

Quadramet is specifically indicated for patients with osteoblastic metastatic bone lesions, primarily those suffering from prostate, breast, multiple myeloma, and other cancers that have spread to the bone. It selectively delivers radiation to areas of new bone formation, providing rapid onset of pain palliation and persistent relief for up to 3-4 months[1][4].

Clinical Benefits

The drug offers several significant clinical benefits, including:

• Rapid Onset of Pain Palliation: Patients experience pain relief as early as one week after administration.
• Persistent Pain Relief: Relief can last up to 3-4 months.
• Predictable and Reversible Myelosuppression: The side effects, particularly on the bone marrow, are predictable and reversible[1].

Market Opportunity

Despite its broad label, the vast majority of Quadramet's use has been in prostate cancer patients, with modest use in breast cancer and little use in lung cancer and myeloma. This targeted market presents both opportunities and challenges:

• Prostate Cancer Dominance: Approximately 86% of the patients treated with Quadramet had prostate cancer, indicating a strong market presence in this segment[4].
• Untapped Markets: The drug's potential in other cancers, such as lung and myeloma, remains largely unexplored, suggesting room for market expansion.

Sales and Prescribing Data

In 2003, Quadramet generated over $7 million in annual sales, with approximately 2,250 patients treated annually at an average of 1.2 doses per patient. The potential for increased revenue was significant if the average number of doses per patient could be increased or if more patients could be converted from prior generation radiopharmaceuticals[1].

Prescribing Physicians

Quadramet is prescribed by medical or radiation oncologists and administered by radiation oncologists or nuclear medicine physicians. The distribution of prescribing physicians includes:

• Radiation Oncologists: 30%
• Medical Oncologists: 23%
• Urologists: 18%
• Nuclear Medicine Physicians: 18%
• Other: 11%[1].

Marketing and Awareness

Cytogen, the company behind Quadramet, implemented various marketing and awareness campaigns in 2004, targeting both patients and physicians through journals like the "Journal of Clinical Oncology" and "Coping with Cancer" magazine. These efforts aimed to increase product awareness and expand its clinical role[1].

Financial Performance

As of 2004, Cytogen's financials reflected a market capitalization of around $200 million, with a net loss of $13.8 million and total revenue of $25 million for the full year 2003. The company received net proceeds of approximately $24 million from a registered direct offering of common stock in April 2004, which helped in funding operations and research[1].

Challenges and Limitations

Despite its clinical benefits, Quadramet faced several challenges:

• Impurities and Toxicity: The drug was eventually removed from the market due to impurities that limited its use in treating bone cancer disease[2].
• Single-Dose Limitation: Quadramet was primarily used as a single-dose treatment, which limited its potential for repeated use and broader therapeutic applications[2].

Next-Generation Alternatives

The development of next-generation radiopharmaceuticals, such as CycloSam by QSAM Biosciences, aims to address the limitations of Quadramet. CycloSam, which also uses samarium-153, offers improved targeting, reduced impurities, and the potential for repeated doses, opening up new indications and larger markets[2].

Market Impact and Future Prospects

The market dynamics for Quadramet highlight the importance of continuous innovation and improvement in radiopharmaceuticals:

• Clinical Development: Ongoing clinical development and publication of safety and efficacy data are crucial for expanding the clinical role of such drugs.
• Regulatory Designations: Designations like orphan and rare pediatric disease designations can provide significant regulatory advantages and financial incentives, as seen with CycloSam[2].

Key Takeaways

• Targeted Therapy: Quadramet is highly effective for pain palliation in patients with osteoblastic metastatic bone lesions, particularly those with prostate cancer.
• Market Potential: Despite its dominance in prostate cancer, there is untapped potential in other cancer types.
• Financial Performance: The drug generated significant revenue but faced financial challenges and eventual market removal due to impurities.
• Next-Generation Alternatives: New radiopharmaceuticals like CycloSam are being developed to overcome the limitations of Quadramet.

FAQs

Q: What is Quadramet used for? A: Quadramet is used for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scans.

Q: Which cancers are most commonly treated with Quadramet? A: Quadramet is most commonly used in patients with prostate cancer, with some use in breast cancer and minimal use in lung cancer and myeloma.

Q: What are the clinical benefits of Quadramet? A: Quadramet offers rapid onset of pain palliation, persistent pain relief up to 3-4 months, and predictable/reversible myelosuppression.

Q: Why was Quadramet eventually removed from the market? A: Quadramet was removed from the market due to impurities that limited its use in treating bone cancer disease.

Q: What are the next-generation alternatives to Quadramet? A: CycloSam, developed by QSAM Biosciences, is a next-generation radiopharmaceutical that aims to improve upon the limitations of Quadramet with better targeting, reduced impurities, and potential for repeated doses.

Sources

1. Cytogen Corporate Presentation - May 24, 2004
2. QSAM Biosciences developing next-gen targeted radiopharmaceuticals for cancer - BioTuesdays, June 14, 2022
3. Lantheus Investor Presentation
4. Quadramet: Package Insert / Prescribing Information - Drugs.com, April 1, 2024