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Generic Folotyn Availability

Folotyn is a brand name of pralatrexate, approved by the FDA in the following formulation(s):

FOLOTYN (pralatrexate - solution;intravenous)

  • Manufacturer: ALLOS
    Approval date: September 24, 2009
    Strength(s): 20MG/ML (20MG/ML), 40MG/2ML (20MG/ML) [RLD]

Has a generic version of Folotyn been approved?

No. There is currently no therapeutically equivalent version of Folotyn available in the United States.

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: About generic drugs.

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.

  • Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors
    Patent 6,028,071
    Issued: February 22, 2000
    Inventor(s): Sirotnak; Francis M. & Piper; James R. & DeGraw; Joseph I. & Colwell; William T.
    Assignee(s): Sloan-Kettering Institute for Cancer Research SRI International Southern Research Institute
    Highly purified 10-propargyl-10-deazaaminopterin (10-propargyl-10dAM) compositions tested in xenograft models for their efficacy against human tumors are shown to be far superior to methotrexate ("MTX") and are even superior to the newer clinical candidate edatrexate ("EDX"). Moreover, 10-propragyl-10dAM showed a surprising ability to cure tumors such that there was no evidence of tumor growth several weeks after the cessation of therapy. Thus, highly purified compositions containing 10-propargyl-10dAM can be used to treat human tumors, particularly human mammary tumors and human lung cancer.
    Patent expiration dates:
    • July 16, 2022
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      Patent use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
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      Drug substance
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      Drug product
  • Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
    Patent 7,622,470
    Issued: November 24, 2009
    Inventor(s): O'Connor; Owen A. & Sirotnak; Francis M.
    Assignee(s): Sloan-Kettering Institute for Cancer Research
    T 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/m2. In general, the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m2 per dose.
    Patent expiration dates:
    • May 31, 2025
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      Patent use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
  • Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
    Patent 8,299,078
    Issued: October 30, 2012
    Inventor(s): O'Connor; Owen A. & Sirotnak; Francis M.
    Assignee(s): Sloan-Kettering Institute for Cancer Research
    T 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/m2. In general, the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m2 per dose.
    Patent expiration dates:
    • May 31, 2025
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      Patent use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA

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 24, 2016 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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