Folotyn

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.

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, 2017
    
    ✓ 
    Patent use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
    ✓ 
    Drug substance
    ✓ 
    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
    
    ✓ 
    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, 2014 - NEW CHEMICAL ENTITY
  
  
  • September 24, 2016 - ORPHAN DRUG EXCLUSIVITY
  
  

See also...

• Folotyn Consumer Information (Drugs.com)
• Folotyn Consumer Information (Wolters Kluwer)
• Folotyn Consumer Information (Cerner Multum)
• Folotyn Advanced Consumer Information (Micromedex)
• Folotyn AHFS DI Monographs (ASHP)
• Pralatrexate Consumer Information (Wolters Kluwer)
• Pralatrexate Consumer Information (Cerner Multum)
• Pralatrexate Intravenous Advanced Consumer Information (Micromedex)
• Pralatrexate AHFS DI Monographs (ASHP)