Generic Tepylute Availability
Last updated on Apr 10, 2025.
Tepylute is a brand name of thiotepa, approved by the FDA in the following formulation(s):
TEPYLUTE (thiotepa - solution;intravenous)
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Manufacturer: SHORLA
Approval date: June 25, 2024
Strength(s): 15MG/1.5ML (10MG/ML) [RLD] -
Manufacturer: SHORLA
Approval date: February 26, 2025
Strength(s): 100MG/10ML (10MG/ML) [RLD]
Is there a generic version of Tepylute available?
No. There is currently no therapeutically equivalent version of Tepylute available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tepylute. 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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Stable formulations comprising thiotepa
Patent 11,975,013
Issued: May 7, 2024
Inventor(s): Cunningham; Sharon et al.
Assignee(s): SHORLA PHARMA LTD. (Co. Tipperary, IE)The present disclosure provides pharmaceutical compositions comprising thiotepa and one selected from PEG, such as PEG400 or PEG600, and DMSO, and optionally water or an aqueous saline solution and thiosulfate. The composition is free or substantially free of impurities. Also provided is a method for treating cancer in a subject, or myeloablation prior to bone marrow transplantation using the composition. A method for enhancing the stability of a thiotepa formulation is also contemplated.
Patent expiration dates:
- August 16, 2041✓
- August 16, 2041
More about Tepylute (thiotepa)
- Check interactions
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- During pregnancy
- FDA approval history
- Drug class: alkylating agents
- Breastfeeding
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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.
