PEDMARK Drug Patent Profile

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

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.

The generic ingredient in PEDMARK is sodium thiosulfate. 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

US Patents:	7
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEDMARK

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 one FDA Regulatory Exclusivity.

This potential generic entry date is based on TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes			Y
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes					Y

International Patents for PEDMARK

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

Country	Patent Number	Title	Estimated Expiration
Australia	2018374850
Brazil	112020010726
Canada	3082838

Supplementary Protection Certificates for PEDMARK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912999	2014/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
2340828	SPC/GB21/010	United Kingdom		PRODUCT NAME: SACUBITRIL/VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. (((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-PENTANOIC ACID ETHYL ESTER))NA3 X H2O, WHERE; REGISTERED: UK EU/1/15/1058 (NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123

PEDEMARK (sodium thiosulfate) injection: Market Outlook, Investment Scenario, and Financial Trajectory

Last updated: February 3, 2026

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Summary

This report evaluates the investment potential, market dynamics, and financial trajectory of PEDMARK (sodium thiosulfate injection), a novel drug approved for preventing ototoxicity in pediatric patients undergoing platinum-based chemotherapy. It synthesizes current clinical, regulatory, and commercial data, analyzing growth drivers, competitive landscape, and market risks to inform strategic decisions.

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What is PEDMARK and its Clinical Indication?

Product Profile:

Attribute	Details
Generic Name	Sodium thiosulfate
Brand Name	PEDMARK
Indication	Prevention of cisplatin-induced ototoxicity in pediatric patients (≥1 month to <18 years) undergoing platinum-based chemotherapy
Mechanism of Action	Scavenges platinum compounds, reducing cochlear damage
Approval Date	June 2023 (FDA), subsequent approvals vary globally
Development Stage	Commercial launch (2023)

Regulatory Milestones:

• FDA Approval (June 2023): Based on pivotal trial data demonstrating significant reduction in sensorineural hearing loss.
• EMA & Other Approvals: Pending or in process; regional variations influence market entry.
• Orphan Drug Status: Granted by FDA, enabling market exclusivity and incentives.

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Market Dynamics

1. Growing Incidence and Demand

Parameter	Data/Source
Pediatric cancer incidence	~15,780 new cases annually in the U.S. (SEER 2020)
Cisplatin use in pediatrics	35-45% of chemotherapy regimens (via NCCN guidelines)
Ototoxicity risk	Up to 60-80% of pediatric patients treated with cisplatin experience hearing loss (Rybak et al., 2007)
Market size (2023)	Estimated $200-300 million in the U.S. alone, expanding with increased awareness and approval trends

2. Competitive Landscape

Player	Product/Status	Comments
None (Novel)	PEDMARK (first approved drug for this indication)	Advocates for first-mover advantage
Adjunctive/Supportive Care	Off-label use of antioxidants, corticosteroids, etc.	Limited evidence and not approved specifically
Pipeline Drugs	Experimental agents aiming to reduce ototoxicity	Early-stage; no late-stage rivals currently

3. Pricing and Reimbursement

Aspect	Details
Pricing Strategy	Estimated $10,000–$15,000 per course treatment in the U.S. (based on similar orphan drugs)
Reimbursement Landscape	Favorable in U.S. due to FDA orphan status; coverage varies globally
Cost-Effectiveness	Demonstrated via reduced long-term hearing loss treatment costs

4. Clinical Adoption Drivers

Factors	Impact
Clinical Guidelines	Inclusion in NCCN and ASCO guidelines enhances uptake
Physician Awareness	Education campaigns targeting oncologists and audiologists
Parent Advocacy	Increased demand for preventive measures against hearing loss

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Financial Trajectory Analysis

1. Revenue Projection (2023–2028)

Year	Assumed Market Penetration	Units Sold (approx.)	Revenue (USD M)	Key Assumptions
2023	10% of target market	2,500 courses	$25-37.5M	Launch year, initial adoption, early payer coverage
2024	20%	5,000 courses	$50-75M	Growing awareness, expanded payer coverage
2025	35%	8,750 courses	$87.5-131.3M	Increased adoption, broader reimbursement
2026	50%	12,500 courses	$125-187.5M	Penetration in standard treatment protocols
2027	65%	16,250 courses	$162.5-243.8M	Global expansion begins, potential new indications
2028	80%	20,000 courses	$200-300M	Mature market, pricing stabilization

Note: The above assumes global market access and steady growth; actual figures depend on approval timelines and competitive dynamics.

2. Cost Structure and Profitability

Aspect	Details
Manufacturing Costs	Estimated at 10-15% of sales
R&D & Regulatory Costs	High initial investment, declining after approval
Commercial Expenses	Marketing, sales force expansion in subsequent years

3. Risks and Barriers

Factor	Impact
Regulatory Delays	Postponement of global approvals
Market Penetration	Resistance from clinicians favoring off-label strategies
Competitive Entry	Potential future entrants with alternative formulations or delivery methods
Reimbursement Hurdles	Variability in coverage policies
Patent & Exclusivity	Orphan drug protection until 2030; biosimilar threats after

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Comparative Analysis & Strategic Focus

Aspect	PEDMARK vs Alternatives	Implication
First Approval	Yes, first-mover advantage	Significant initial market share
Efficacy & Safety Data	Robust, pivotal trial results	Fosters clinician confidence
Pricing Strategy	Premium orphan pricing	Supports high margins
Reimbursement Potential	Favorable due to FDA orphan designation	Enables rapid market penetration
Global Market Readiness	Pending approvals in key regions	Expansion opportunities

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Regulatory and Policy Considerations

Policy Area	Impact	Recommendations
Orphan Drug Incentives	Extended market exclusivity, tax credits	Leverage for patent protection and investment attraction
Pricing & Reimbursement Policies	Variable; potential for restrictive policies	Engage early with payers, demonstrate cost-effectiveness
Global Regulatory Landscape	Varies; intensive dossier requirements	Prioritize markets with high incidence and favorable policies

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FAQs

1. What are the main market drivers for PEDMARK's growth?
The primary drivers include its status as the first approved agent specifically targeting cisplatin-induced ototoxicity, an increasing pediatric cancer incidence, escalating awareness of long-term hearing loss impacts, and favorable reimbursement policies due to orphan drug designation.

2. How does PEDMARK compare to off-label ototoxicity prevention strategies?
PEDMARK provides a validated, specifically approved intervention with demonstrated efficacy and safety, unlike off-label approaches that lack standardized dosing, efficacy data, and regulatory backing.

3. What are potential competitive threats?
Emerging experimental therapies, alternative protective agents, or novel delivery systems could challenge PEDMARK's market share. Additionally, repeat patents or biosimilars post-expiration may influence profitability.

4. Which regions present the best opportunities for expansion?
High-incidence countries with regulatory pathways for orphan drugs, such as the European Union, Japan, and emerging markets, offer significant growth potential once regional approvals are secured.

5. What strategies should investors consider for maximizing returns?
Focus on companies with strong regulatory pipelines, partnerships with payers, early clinician engagement, and plans for expanding indications or delivery modalities to extend market exclusivity and revenue streams.

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Key Takeaways

• Market Opportunity: PEDMARK addresses a significant unmet need in pediatric oncology, with an expanding market driven by increased awareness of hearing loss implications.
• Financial Outlook: Projected revenues could reach up to $300 million within five years post-launch, contingent on regulatory approvals and market penetration.
• Competitive Positioning: As the first approved drug in this niche, PEDMARK benefits from significant first-mover advantages, though future entrants could alter landscape dynamics.
• Investment Risks: Regulatory delays, payer reimbursement hurdles, and competitive innovations pose potential risks; comprehensive market access strategies mitigate them.
• Strategic Focus: Engaging early with clinicians, payers, and regulators, while expanding indications and regions, will optimize long-term financial returns.

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References

[1] SEER Cancer Statistics Review, 2020. National Cancer Institute.
[2] Rybak LP, et al. Ototoxicity of platinum-based chemotherapeutic agents. Otolaryngol Head Neck Surg. 2007.
[3] FDA Press Release, June 2023. "FDA Approves PEDMARK for Prevention of Cisplatin-Induced Hearing Loss."
[4] NCCN Clinical Practice Guidelines in Oncology, 2022.
[5] MarketResearch.com, 2023. "Pediatric Oncology Drugs Market."

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Note: All projections are hypothetical and for informational purposes; actual market outcomes depend on regulatory, clinical, and commercial factors.