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-nine patent family members in twenty-six 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:	59
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PEDMARK

Constraining patent/regulatory exclusivity:

TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS

NDA:

212937

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PEDMARK

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

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

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
Australia	2018374850
Brazil	112020010726
Canada	3082838

Supplementary Protection Certificates for PEDMARK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	06C0021	France		PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516

Last updated: May 31, 2026

PEDMARK market dynamics and financial trajectory (financial outlook, exclusivity, payer access, and launch risk)

Executive summary: PEDMARK (palifermin) is a niche oncology supportive-care product with a constrained addressable market tied to specific conditioning regimens for hematologic malignancies. Its financial trajectory is dominated by (1) entitlement status and payer utilization of prophylactic mucositis therapy, (2) competitive pressure from alternative mucositis-prevention strategies and supportive regimens, and (3) the degree to which newer clinical pathways or transplant protocols shift patient selection away from palifermin-indicated use. The key market-dynamic variables are contracting, formulary positioning, and pharmacy benefit management (PBM) controls rather than broad primary-care distribution.

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What is PEDMARK (palifermin) and where is it used commercially?

Featured snippet: PEDMARK is palifermin, a keratinocyte growth factor (KGF) used as prophylaxis to reduce the incidence and duration of oral mucositis in patients undergoing hematopoietic stem cell transplantation conditioning regimens.

Key market-facing attributes that shape adoption

• Indication specificity: Demand is constrained to patients receiving the qualifying conditioning context rather than general mucositis use.
• Setting concentration: Uptake is concentrated among transplant centers with established supportive-care protocols.
• Treatment timing discipline: Adoption depends on operational fit into transplant workflows and scheduling around conditioning and transplantation.

Commercial implications for revenue

• Base sales track transplant volumes and patient eligibility rather than overall oncology spend.
• Utilization is sensitive to protocol revisions, clinical guideline updates, and formulary contracting cycles.

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How does PEDMARK pricing, payer coverage, and contracting drive revenue?

Featured snippet: PEDMARK revenue is driven more by payer coverage and contract economics than by new prescriber acquisition, given the limited patient population and transplant-center prescribing patterns.

Payer and channel dynamics

• Hospital acquisition model: Much of the purchasing occurs via hospital pharmacy and specialty purchasing systems, with payer reimbursement often channelled through institutional billing.
• PBM controls and prior authorization: Even when product is used in the hospital setting, payers can impose utilization management that affects net pricing and the mix of covered patients.
• Center-specific formularies: Transplant centers often standardize supportive-care regimens, which can lock in or delay adoption of palifermin.

Net price and margin compression risk

• In niche hospital therapies, reimbursement pressure typically shows up as:
  • tighter contracting around bundled oncology supportive-care spend,
  • increased discounting in managed-care contracts,
  • administrative friction that reduces covered utilization.

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What are the major market dynamics affecting PEDMARK demand?

Featured snippet: Demand is most sensitive to transplant protocol selection, mucositis prevention standards of care, and utilization management.

Clinical pathway shifts

• Transplant conditioning regimens and supportive-care bundles can reduce the eligible population for palifermin or change timing and dosing requirements.
• Competing supportive approaches can displace palifermin at the margin even when not direct substitutes in every protocol.

Institutional adoption curve

• Uptake depends on:
  • clinician familiarity,
  • nursing and pharmacy workflow fit,
  • evidence-based protocol inclusion,
  • contracting terms that determine whether clinicians can standardize use.

Therapeutic substitution

• If guideline-concordant alternatives reduce severity/duration of mucositis and are easier to procure, palifermin utilization can decline without changes to regulatory status.

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When does PEDMARK lose exclusivity and how does that affect market risk?

Featured snippet: The financial trajectory for PEDMARK is typically shaped by the exclusivity and patent landscape around palifermin, with the highest downside risk around generic or biosimilar-like entry (depending on how the IP and regulatory classification play out for the specific product lineage).

What drives the timing of generic/biosimilar entry risk

• Patent estate durability: Composition, use, formulation, and manufacturing process patents can extend effective exclusivity.
• Regulatory pathway for follow-ons: If follow-on sponsors pursue an FDA pathway that triggers enforceable challenges, the market can shift rapidly after settlement or final invalidation.
• Settlement leverage: If branded PEDMARK holders settle, launch timing is often pulled out but the price-discount pressure begins before generic entry.

Financial impact mechanics

• Net sales usually decline in steps:
  • pre-launch contract renegotiations,
  • post-entry price erosion and mix shift,
  • reversion to standard-of-care alternatives where appropriate.

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What patent protection covers PEDMARK and how strong is the estate?

Featured snippet: Patent strength is assessed via the number and breadth of active patents covering palifermin product claims, therapeutic use, and manufacturing methods, and whether those claims are enforceable through the expected end of market exclusivity.

Patent categories that matter for PEDMARK

• Composition of matter: Core product molecules or controlled variants.
• Method-of-use: Prophylactic administration schedules and patient populations.
• Formulation/process: Manufacturing steps and stability/bioburden controls that constrain generic replication.

Litigation and enforceability

• Where branded holders litigate, the market impact is:
  • delay of first generic filing approvals,
  • settlement that sets a launch date,
  • sustained brand preference at transplant centers through contract terms.

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What FDA status does PEDMARK have and what does that mean for future entry?

Featured snippet: FDA status and listing on relevant product reference systems determine whether follow-on manufacturers can file, at what time, and under which legal challenges.

Regulatory footprint that drives economics

• Label breadth: Narrow indication breadth keeps utilization low but reduces substitution risk only if follow-on products must match specific conditions.
• Manufacturing controls: For biologics-like products, manufacturing comparability and analytics can slow competitive entry even after regulatory approval.

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How many patents and what jurisdictions affect PEDMARK competition risk?

Featured snippet: Competition risk depends on the number of enforceable patents and their remaining term across key jurisdictions that govern commercial entry in those markets.

Jurisdictional revenue concentration

• Revenue exposure is highest where:
  • patent enforcement is effective,
  • healthcare reimbursement supports coverage,
  • institutional procurement is centralized,
  • follow-on regulatory pathways enable faster substitution.

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What generic entry risks exist for PEDMARK?

Featured snippet: The highest generic entry risk is around the intersection of remaining exclusivity and the enforceability of method-of-use and manufacturing process patents.

Entry pathways and launch scenarios

• Scenario A: no successful challenge
  • Brand retains exclusivity longer.
  • Revenue declines gradually via utilization management and contracting pressure rather than step-function price erosion.
• Scenario B: successful challenge or settlement
  • A launch date is set that can trigger immediate price discounting.
  • Transplant centers switch only if procurement and reimbursement allow.

Commercial consequences

• Post-entry, net sales typically compress because:
  • hospitals seek lower-cost options within the same supportive-care regimen,
  • PBMs and group purchasing organizations standardize contracts to reduce acquisition cost.

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How does PEDMARK compare with alternative therapies for oral mucositis prevention?

Featured snippet: PEDMARK’s commercial positioning hinges on prophylactic efficacy in the specific hematopoietic stem cell transplant context; alternatives compete by ease of procurement, dosing practicality, and coverage.

Comparison dimensions that influence formulary placement

• Dosing schedule fit within transplant protocols
• Evidence strength for endpoints used in payer decision-making (incidence, duration, hospitalization impact)
• Contractability and net price strategy
• Workflow fit for pharmacy and nursing teams

Market dynamics versus pure clinical efficacy

In niche supportive care, coverage and procurement often dictate realized uptake more than incremental clinical endpoints.

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What litigation and settlement events could change PEDMARK’s market trajectory?

Featured snippet: Litigation outcomes shape effective exclusivity and can trigger step-change sales through entry timing, settlement-based launch dates, and contract renegotiations.

Key events that move market expectations

• Patent infringement findings or injunction threats
• Court rulings on claim validity
• Settlement agreements that specify:
  • earliest allowed launch date,
  • carve-outs on product characteristics,
  • limitations on promotional or patient population targeting.

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What does the PEDMARK financial trajectory likely look like under different demand and entry scenarios?

Featured snippet: The financial trajectory is typically a function of transplant-volume-linked demand plus a second axis of exclusivity-driven competitive entry risk.

Scenario-based trajectory framework

• Base case: Stable or slow declines tied to transplant volumes, payer pressure, and utilization management.
• Downside case: Faster declines if competitive alternatives gain guideline traction or if contractual net prices fall.
• IP cliff case: Step-function net sales decline if protected claims are invalidated or settlement accelerates entry.

Where the inflection points usually appear

• After payer policy changes
• After guideline updates that shift supportive care bundles
• Around the effective end of market exclusivity or major patent expirations

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Key takeaways

• PEDMARK demand is constrained by indication specificity and transplant-center prescribing ecosystems, not broad oncology prescribing.
• Revenue is driven by payer contracting, institutional formulary placement, and utilization management more than by general market expansion.
• The main financial downside risks are (1) protocol and supportive-care standard shifts that reduce eligible utilization and (2) patent and exclusivity timelines that determine competitive entry timing.
• Step-change market risk is concentrated around effective exclusivity end points and any settlement-triggered launch windows.

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FAQs

1) What drives PEDMARK utilization at transplant centers?

Transplant protocol inclusion, institutional formulary decisions, and payer coverage rules.

2) Does PEDMARK adoption depend more on clinical outcomes or procurement economics?

Both matter, but payer contracting and institutional procurement constraints usually determine realized volume.

3) What is the largest financial risk for PEDMARK revenue?

Effective exclusivity and the timing of competitive entry, paired with net price erosion from payer and contract pressure.

4) How sensitive is PEDMARK demand to changes in conditioning regimens?

Moderately to highly, because patient eligibility and timing within transplant workflows can change with protocol selection.

5) What outcomes do payers typically focus on for mucositis prophylaxis?

Incidence and duration of oral mucositis and downstream utilization impacts that affect length of stay and supportive care costs.

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References (APA)

No sources were cited because no PEDMARK-specific patent, FDA, Orange Book, litigation, or financial-year data was provided in the prompt.