Prograf

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

PROGRAF (tacrolimus - capsule; oral)

• 
  Manufacturer: ASTELLAS
  
  Approval date: April 8, 1994
  
  Strength(s): EQ 1MG BASE ^[AB], EQ 5MG BASE ^[RLD][AB]


• 
  Manufacturer: ASTELLAS
  
  Approval date: August 24, 1998
  
  Strength(s): EQ 0.5MG BASE ^[AB]

PROGRAF (tacrolimus - injectable; injection)

• 
  Manufacturer: ASTELLAS
  
  Approval date: April 8, 1994
  
  Strength(s): EQ 5MG BASE/ML ^[RLD]

Has a generic version of Prograf been approved?

A generic version of Prograf has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Prograf and have been approved by the FDA:

tacrolimus capsule; oral

• 
  Manufacturer: DR REDDYS LABS LTD
  
  Approval date: May 12, 2010
  
  Strength(s): EQ 0.5MG BASE ^[AB], EQ 1MG BASE ^[AB], EQ 5MG BASE ^[AB]


• 
  Manufacturer: MYLAN
  
  Approval date: September 17, 2010
  
  Strength(s): EQ 0.5MG BASE ^[AB], EQ 1MG BASE ^[AB], EQ 5MG BASE ^[AB]


• 
  Manufacturer: SANDOZ
  
  Approval date: August 10, 2009
  
  Strength(s): EQ 0.5MG BASE ^[AB], EQ 1MG BASE ^[AB], EQ 5MG BASE ^[AB]


• 
  Manufacturer: WATSON LABS
  
  Approval date: July 1, 2010
  
  Strength(s): EQ 5MG BASE ^[AB]

Note: No generic formulation of the following product is available.

• tacrolimus - injectable; injection

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Prograf. 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

There are no current U.S. patents associated with Prograf.

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:
  • March 29, 2013 - ORPHAN DRUG EXCLUSIVITY
  
  

See also...

• Prograf Consumer Information (Drugs.com)
• Prograf Consumer Information (Wolters Kluwer)
• Prograf Capsules Consumer Information (Wolters Kluwer)
• Prograf Consumer Information (Cerner Multum)
• Prograf Advanced Consumer Information (Micromedex)
• Prograf AHFS DI Monographs (ASHP)
• Tacrolimus Consumer Information (Wolters Kluwer)
• Tacrolimus Capsules Consumer Information (Wolters Kluwer)
• Tacrolimus Consumer Information (Cerner Multum)
• Tacrolimus Oral, Intravenous Advanced Consumer Information (Micromedex)
• Tacrolimus AHFS DI Monographs (ASHP)