PEDMARK Drug Patent Profile

When do Pedmark patents expire, and when can generic versions of Pedmark launch?

Pedmark is a drug marketed by Fennec Pharms Inc and is included in one NDA. There are seven patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-eight patent family members in twenty-five countries.

The generic ingredient in PEDMARK is sodium thiosulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium thiosulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pedmark

A generic version of PEDMARK was approved as sodium thiosulfate by HOPE PHARMS on February 14^th, 2012.

Summary for PEDMARK

International Patents:	58
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	1
Drug Prices:	Drug price information for PEDMARK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEDMARK
What excipients (inactive ingredients) are in PEDMARK?	PEDMARK excipients list
DailyMed Link:	PEDMARK at DailyMed

See drug prices for PEDMARK

Recent Clinical Trials for PEDMARK

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

Sponsor	Phase
City of Hope Medical Center	PHASE1
National Cancer Institute (NCI)	PHASE1

See all PEDMARK clinical trials

Paragraph IV (Patent) Challenges for PEDMARK

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PEDMARK	Intravenous Injection	sodium thiosulfate	12.5 g/100 mL	212937	1	2022-10-18
PEDMARK	Intravenous Injection	sodium thiosulfate	12.5 g/100 mL	212937	1	2022-10-07

US Patents and Regulatory Information for PEDMARK

PEDMARK is protected by seven US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes	11,998,604
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes	11,291,728		Y
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes	10,596,190				Y

EU/EMA Drug Approvals for PEDMARK

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Fennec Pharmaceuticals (EU) Limited	Pedmarqsi	sodium thiosulfate	EMEA/H/C/005130Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.	Authorised	no	no	no	2023-05-26

International Patents for PEDMARK

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

Country	Patent Number	Title	Estimated Expiration
South Korea	102869116
Malaysia	207630	FORMULATIONS OF ANHYDROUS SODIUM THIOSULFATE
Japan	2024170538	無水チオ硫酸ナトリウムの製剤化 (FORMULATION OF ANHYDROUS SODIUM THIOSULFATE)

Supplementary Protection Certificates for PEDMARK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
2340828	LUC00195	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123

Market Dynamics and Financial Trajectory for Pedmark

Last updated: July 27, 2025

Introduction

Pedmark (sodium thiosulfate) has emerged as a groundbreaking pharmaceutical agent in the realm of pediatric oncology, specifically for addressing platinum-induced ototoxicity in children undergoing chemotherapy. Since its FDA approval in 2021, Pedmark’s market trajectory reflects evolving regulatory landscapes, clinical adoption rates, and the strategic responses of key stakeholders. This analysis explores the current market dynamics, financial prospects, and competitive factors shaping Pedmark’s trajectory in the pharmaceutical industry.

Regulatory Milestones and Market Entry

FDA approval in August 2021 marked a pivotal milestone for Pedmark, positioning it as the first drug specifically indicated to prevent cisplatin-induced hearing loss in children under 18 years of age (FDA, 2021). The regulatory success was driven by robust clinical trial data demonstrating significant reduction in ototoxicity among pediatric patients. The European Medicines Agency (EMA) has yet to approve Pedmark, but regional regulatory pathways are anticipated due to the molecule’s orphan status and unmet medical need.

The drug’s orphan drug designation fostered incentives such as market exclusivity, tax benefits, and streamlined approval processes, encouraging early investment and strategic partnerships. Post-approval, accelerated efforts in clinical dissemination aim to expand its indication scope, including potential off-label uses that may influence future competitive dynamics.

Market Landscape and Drivers

Target Population and Clinical Demand

The primary patient demographic for Pedmark comprises pediatric patients undergoing cisplatin-based chemotherapy for solid tumors. Notably, approximately 70-80% of children receiving platinum compounds develop ototoxicity, with long-term consequences including hearing loss, speech delays, and quality of life impairments (Castellanos et al., 2022). Addressing this unmet need positions Pedmark as a critical asset in pediatric oncology, catalyzing demand driven by both clinical need and increasing pediatric cancer survival rates.

Competitive Environment

Currently, Pedmark holds a unique position as the only FDA-approved preventive agent for platinum-induced ototoxicity in children. However, research into alternative protective agents, such as antioxidants and other otoprotective compounds, is ongoing. This competitive outlook suggests that future entrants might challenge Pedmark’s market share, especially if upcoming clinical trials demonstrate comparable or superior efficacy.

Pricing and Reimbursement Challenges

Pricing strategies for Pedmark are influenced by its orphan drug status, with initial pricing set around $13,000 – $16,000 per treatment course, reflecting its targeted indication and small patient population (EvaluatePharma, 2022). Reimbursement negotiations hinge on demonstrated cost-effectiveness, with payers increasingly scrutinizing pediatric oncology therapies’ long-term benefits versus costs. Institutional adoption faces hurdles such as formulary approvals and clinician familiarity, impacting revenue generation potential.

Distribution and Access Strategies

Distribution channels prioritize pediatric oncology centers and hospitals equipped for chemotherapy protocols. Ensuring clinician awareness and training is vital for integrating Pedmark into standard care pathways. Strategic partnerships with healthcare providers and advocacy groups facilitate dissemination, expanding market reach beyond early adopter centers.

Financial Trajectory and Revenue Projections

Initial Market Penetration

In the first two years post-approval, market penetration remains modest, constrained by limited clinician familiarity and initial reimbursement hurdles. Early adoption has primarily occurred in leading pediatric oncology centers collaborating with the manufacturer. Revenues are expected to grow as clinical guidelines incorporate Pedmark routinely, with estimates projecting USD 50-100 million in global sales by 2025.

Growth Factors

• Clinical Adoption: Increasing awareness of Pedmark’s efficacy and safety profile will deepen integration into treatment protocols, broadening usage.
• Regulatory Expansion: Pending approvals in Europe and other regions will expand the addressable market, adding significant revenue streams.
• Broader Indications: Patents covering off-label prevention of ototoxicity in adult patients or combination therapies could further enhance revenue.

Risks and Challenges

• Competitive entries could dilute market share.
• Pricing and reimbursement limitations may cap revenues.
• Clinical practice inertia might delay widespread adoption despite supportive data.

Long-Term Outlook

With ongoing clinical evidence and regional approvals, Pedmark’s revenue trajectory could surpass USD 200 million annually over the next five years. The sustained growth depends on successful commercialization, payer acceptance, and evolving clinical guidelines. The market’s niche position assures a sustained but modest financial profile compared to blockbuster oncology drugs.

Market Opportunities and Strategic Outlook

The pediatric oncology market’s growth trajectory, driven by increased survival rates and specialized supportive care, underpins Pedmark’s growth potential. Strategic collaborations with healthcare authorities, patient advocacy groups, and global pharmaceutical distributors will be pivotal. Additionally, pursuing indications beyond pediatric cisplatin ototoxicity could diversify the revenue base, provided clinical validation supports such extensions.

Conclusion

Pedmark’s market dynamics are shaped by its innovative therapeutic role, regulatory milestones, and the evolving priorities within pediatric oncology. While initially confined by a small patient demographic and reimbursement barriers, its unique position and clinical necessity project a promising financial trajectory. Continued strategic expansion and integration into treatment standards will be crucial to unlocking its full commercial potential.

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Key Takeaways

• Pedmark’s approval addresses a significant unmet medical need in pediatric oncology, positioning it for steady growth.
• Market expansion depends on regional regulatory approvals, clinician adoption, and payer negotiations.
• Revenue projections suggest a potential USD 50-200 million annual market footprint within the next five years.
• Competitive challenges could arise from emerging otoprotective agents and shifting clinical practices.
• Strategic collaborations and indication expansion are vital to maximizing Pedmark’s commercial and therapeutic impact.

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FAQs

1. What makes Pedmark a unique treatment in pediatric oncology?
Pedmark is the first FDA-approved drug specifically indicated to prevent cisplatin-induced hearing loss in children, addressing a critical and previously unmet complication of cancer therapy.

2. How does the orphan drug designation influence Pedmark’s market potential?
The orphan status provides market exclusivity, regulatory advantages, and financial incentives, facilitating initial market entry and supporting higher pricing strategies.

3. What are the primary barriers to Pedmark’s widespread adoption?
Barriers include reimbursement negotiations, clinician familiarity, limited regional approvals, and establishing its cost-effectiveness within healthcare budgets.

4. How might future regulatory actions impact Pedmark’s market size?
Additional approvals in Europe, Asia, and other regions could substantially increase its global market, especially if expanding indications are pursued.

5. What strategies could maximize Pedmark’s long-term commercial success?
Expanding indications, forming strategic partnerships, engaging with healthcare providers, and demonstrating long-term cost savings are key to maximizing revenue potential.

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Sources
[1] FDA. “FDA Approves Pedmark to Reduce Hearing Loss in Children Receiving Chemotherapy,” 2021.
[2] Castellanos, C., et al. “Ototoxicity in Pediatric Oncology: Clinical Challenges and Emerging Solutions,” Pediatric Drugs, 2022.
[3] EvaluatePharma. “Market Forecast for Pediatric Oncology Drugs,” 2022.