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 thirty-six patent family members in thirteen 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:	36
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	156
Drug Prices:	Drug price information for PEDMARK
What excipients (inactive ingredients) are in PEDMARK?	PEDMARK excipients list
DailyMed Link:	PEDMARK at DailyMed

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

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/005130 Pedmarqsi 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
European Patent Office	3817751	FORMULATIONS DE THIOSULFATE DE SODIUM ANHYDRE (FORMULATIONS OF ANHYDROUS SODIUM THIOSULFATE)
European Patent Office	3716987	PROCÉDÉ DE RÉDUCTION DE L'OTOTOXICITÉ CHEZ DES PATIENTS PÉDIATRIQUES RECEVANT UNE CHIMIOTHÉRAPIE À BASE DE PLATINE (METHOD FOR REDUCING OTOTOXICITY IN PEDIATRIC PATIENTS RECEIVING PLATINUM-BASED CHEMOTHERAPY)
Singapore	11202013220S	ANHYDROUS SODIUM THIOSULFATE AND FORMULATIONS THEREOF
Mexico	2020005572	MÉTODO PARA REDUCIR OTOTOXICIDAD EN PACIENTES PEDIÁTRICOS QUE RECIBEN QUIMIOTERAPIA BASADA EN PLATINO. (METHOD FOR REDUCING OTOTOXICITY IN PEDIATRIC PATIENTS RECEIVING PLATINUM-BASED CHEMOTHERAPY.)
Israel	274645	שיטה להפחתת אוטוטוקסיות בילדים חולים המקבלים כימותרפיה מבוסס פלטינום (Method for reducing ototoxicity in pediatric patients receiving platinum-based chemotherapy)
Brazil	112021000021	tiossulfato de sódio anidro e formulações do mesmo

Supplementary Protection Certificates for PEDMARK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0579826	02C0041	France		PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
2666774	CR 2020 00037	Denmark		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
3347352	2290051-8	Sweden		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819
2822954	SPC/GB18/031	United Kingdom		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
2822954	LUC00083	Luxembourg		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625

PEDMARK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PEDMARK

Introduction to PEDMARK

PEDMARK, developed by Fennec Pharmaceuticals, is a groundbreaking drug designed to prevent ototoxicity (hearing loss) in children undergoing chemotherapy. The drug has garnered significant attention and traction in the pharmaceutical market, particularly in the pediatric oncology sector.

Regulatory Milestones

PEDMARK has achieved several critical regulatory milestones that have bolstered its market position. In the U.S., it has received Orphan Drug Exclusivity, providing a competitive edge by preventing other similar drugs from being approved for the same indication for a period of seven years[1].

In Europe, PEDMARQSI, the European counterpart of PEDMARK, has received Pediatric Use Marketing Authorization, which includes eight years of market exclusivity[1].

Revenue Growth and Financial Performance

Quarterly and Annual Revenues

PEDMARK has demonstrated robust revenue growth. In the second quarter of 2024, the drug generated $7.3 million in net product sales, a 121% increase from the $3.3 million reported in the second quarter of 2023[2].

For the full year 2023, PEDMARK achieved net revenues of approximately $21 million, a significant jump from $1.5 million in fiscal year 2022[4].

Licensing Revenue

A key contributor to Fennec's financial performance in 2024 was the exclusive licensing agreement with Norgine for the commercialization of PEDMARQSI in Europe, Australia, and New Zealand. This deal brought in $18 million in licensing revenue in the first quarter of 2024, significantly boosting total net revenues to $25.4 million for the quarter[5].

Market Traction and Expansion

Community Oncology and AYA Population

Fennec Pharmaceuticals is focusing on expanding PEDMARK's reach to community oncology centers and the adolescent and young adult (AYA) population. The update of the NCCN AYA Guidelines, which removed specific terms for 'pediatric,' could potentially expand the patient population for PEDMARK[2].

International Market

The partnership with Norgine is expected to further enhance PEDMARK's market presence in Europe, Australia, and New Zealand. Norgine's launch of PEDMARQSI in these regions indicates strong market potential and is anticipated to drive additional revenue growth[4].

Operating Expenses and Cash Position

Operating Expenses

Despite the revenue growth, Fennec Pharmaceuticals has seen an increase in operating expenses. Selling and marketing expenses rose to $4.7 million in the second quarter of 2024 from $2.3 million in the same period of 2023. General and administrative expenses also increased to $6.9 million from $5.5 million year-over-year[2].

Cash Position

As of June 30, 2024, Fennec Pharmaceuticals had a cash position of approximately $43.1 million, providing a solid financial foundation for ongoing operations and potential expansion[2].

Net Loss and Financial Health

Net Loss

In the second quarter of 2024, Fennec reported a net loss of $5.6 million, compared to a net loss of $5.4 million in the second quarter of 2023. Despite this, the company remains optimistic about its financial health and future prospects[2].

Gross Profit Margin

Fennec Pharmaceuticals boasts an impressive gross profit margin of nearly 95% over the last twelve months as of Q3 2023, highlighting the financial viability and profitability of PEDMARK[4].

Future Outlook

Sales Growth Expectations

Analysts and the company itself anticipate continued sales growth for PEDMARK, particularly following the clarification of the FDA notice and the resolution of the J-Code reimbursement issue. The amended permanent J-Code, effective April 1, 2024, clearly specifies PEDMARK from other formulations of sodium thiosulfate (STS), which is expected to further boost sales[5].

Expansion Plans

Fennec Pharmaceuticals plans to leverage the upfront cash from the Norgine deal to potentially expand its drug pipeline, although specific plans have not been announced yet[4].

Key Takeaways

• Revenue Growth: PEDMARK has shown significant revenue growth, with a 121% increase in Q2 2024 compared to Q2 2023.
• Licensing Agreement: The exclusive licensing deal with Norgine has substantially boosted Fennec's financial position.
• Market Expansion: The drug is being targeted at community oncology centers and the AYA population, with potential expansion in Europe, Australia, and New Zealand.
• Financial Health: Despite operating losses, Fennec has a strong cash position and impressive gross profit margins.
• Future Outlook: Anticipated sales growth and potential pipeline expansion are key drivers for Fennec's future success.

FAQs

Q: What is PEDMARK used for?

PEDMARK is used to prevent ototoxicity (hearing loss) in children undergoing chemotherapy.

Q: What regulatory milestones has PEDMARK achieved?

PEDMARK has received Orphan Drug Exclusivity in the U.S. and Pediatric Use Marketing Authorization in Europe, including eight years of market exclusivity[1].

Q: How has PEDMARK's revenue grown?

PEDMARK's revenue grew by 121% in Q2 2024 compared to Q2 2023, with full-year 2023 revenues reaching $21 million[2][4].

Q: What is the impact of the Norgine licensing agreement on Fennec's finances?

The Norgine licensing agreement brought in $18 million in licensing revenue in Q1 2024 and is expected to further boost PEDMARK's market presence in Europe, Australia, and New Zealand[5].

Q: What are Fennec's plans for the future?

Fennec plans to leverage the upfront cash from the Norgine deal to potentially expand its drug pipeline and expects continued sales growth for PEDMARK following recent regulatory clarifications[4].

Sources

1. Fennec Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Business Update - Investors.fennecpharma.com
2. Fennec Pharmaceuticals Reports Second Quarter 2024 Financial Results - Stocktitan.net
3. Fennec Pharmaceuticals Announces First Quarter 2023 Financial Results - Investors.fennecpharma.com
4. Earnings call: Fennec Pharmaceuticals reports solid PEDMARK sales, eyes expansion - Investing.com
5. Fennec Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update - Biospace.com