Generic Folotyn Availability
Last updated on Apr 10, 2024.
Folotyn is a brand name of pralatrexate, approved by the FDA in the following formulation(s):
FOLOTYN (pralatrexate - solution;intravenous)
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Manufacturer: ACROTECH BIOPHARMA
Approval date: September 24, 2009
Strength(s): 20MG/ML (20MG/ML) [RLD], 40MG/2ML (20MG/ML) [RLD]
Has a generic version of Folotyn been approved?
An Authorized Generic version of Folotyn has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.
List of authorized generic versions:
- Pralatrexate INTRAVENOUS INJECTION 20 mg/mL
Fresenius Kabi USA, LLC
NDC Code: 652190550 - Pralatrexate INTRAVENOUS INJECTION 40 mg/2mL
Fresenius Kabi USA, LLC
NDC Code: 652190552
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Folotyn. 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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Patent 7,622,470
Patent expiration dates:
- May 31, 2025✓
- May 31, 2025
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Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Patent 8,299,078
Issued: October 30, 2012
Inventor(s): "OConnor Owen A." & Sirotnak Francis M.
Assignee(s): Sloan-Kettering Institute for Cancer ResearchT cell lymphoma is treated by administering to a patient suffering from T cell lymphoma a therapeutically effective amount of 10-propargyl-10-deazaaminopterin. Remission is observed in human patients, even with drug resistant T cell lymphoma at weekly dosages levels as low as 30 mg/m. In general, the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/mper dose.
Patent expiration dates:
- May 31, 2025✓
- May 31, 2025
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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.