Generic Pedmark Availability
Last updated on Nov 6, 2024.
Pedmark is a brand name of sodium thiosulfate, approved by the FDA in the following formulation(s):
PEDMARK (sodium thiosulfate - solution;intravenous)
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Manufacturer: FENNEC PHARMS INC
Approval date: September 20, 2022
Strength(s): 12.5GM/100ML (125MG/ML) [RLD]
Has a generic version of Pedmark been approved?
No. There is currently no therapeutically equivalent version of Pedmark available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pedmark. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Method for reducing ototoxicity in pediatric patients receiving platinum-based chemotherapy
Patent 10,596,190
Issued: March 24, 2020
Inventor(s): Neuwelt Edward A.
Assignee(s): Oregon Health & Science UniversityDescribed herein is a method for eliminating or reducing ototoxicity in patients receiving a platinum based chemotherapeutic. In particular, are methods of reducing ototoxicity in a pediatric patient. The methods described herein include administering an effective amount of sodium thiosulfate to a patient in need thereof to reduce ototoxicity.
Patent expiration dates:
- January 5, 2038✓✓
- January 5, 2038
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Anhydrous sodium thiosulfate and formulations thereof
Patent 11,291,728
Issued: April 5, 2022
Inventor(s): Lovelace Thomas Claiborne & Moore & III Joseph Alexander & Lee Christopher McKinnon & Kirschner Daniel Logan
Assignee(s): FENNEC PHARMACEUTICALS, INC.Described herein is anhydrous sodium thiosulfate, methods for synthesizing anhydrous sodium thiosulfate, pharmaceutical compositions thereof, and methods of treating ototoxicity. Anhydrous sodium thiosulfate is synthesized from sodium sulfite, sulfur, and cetylpyridinium chloride. The anhydrous sodium thiosulfate is formulated into a pharmaceutical composition comprising a buffer and solvent. These compositions are useful for eliminating or reducing ototoxicity in pediatric patients receiving platinum based chemotherapeutics.
Patent expiration dates:
- July 1, 2039✓
- July 1, 2039
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Anhydrous sodium thiosulfate and formulations thereof
Patent 11,510,984
Issued: November 29, 2022
Inventor(s): Lovelace Thomas Claiborne & Moore & III Joseph Alexander & Lee Christopher McKinnon & Kirschner Daniel Logan
Assignee(s): Fennec Pharmaceuticals, Inc.Described herein is anhydrous sodium thiosulfate, methods for synthesizing anhydrous sodium thiosulfate, pharmaceutical compositions thereof, and methods of treating ototoxicity. Anhydrous sodium thiosulfate is synthesized from sodium sulfite, sulfur, and cetylpyridinium chloride. The anhydrous sodium thiosulfate is formulated into a pharmaceutical composition comprising a buffer and solvent. These compositions are useful for eliminating or reducing ototoxicity in pediatric patients receiving platinum-based chemotherapeutics.
Patent expiration dates:
- July 1, 2039✓
- July 1, 2039
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Patent 11,617,793
Patent expiration dates:
- July 1, 2039✓
- July 1, 2039
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Patent 11,964,018
Patent expiration dates:
- July 1, 2039✓
- July 1, 2039
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Patent 11,992,530
Patent expiration dates:
- July 1, 2039✓
- July 1, 2039
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Patent 11,998,604
Patent expiration dates:
- July 1, 2039✓
- July 1, 2039
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- September 20, 2025 - NEW PRODUCT
- September 20, 2029 - TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS
More about Pedmark (sodium thiosulfate)
- Compare alternatives
- Pricing & coupons
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: antineoplastic detoxifying agents
Patient resources
Professional resources
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
