Friday, September 30, 2016

Tamiflu


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


TAMIFLU (oseltamivir phosphate - capsule; oral)



  • Manufacturer: ROCHE

    Approval date: October 27, 1999

    Strength(s): EQ 75MG BASE [RLD]


  • Manufacturer: ROCHE

    Approval date: July 2, 2007

    Strength(s): EQ 30MG BASE, EQ 45MG BASE

TAMIFLU (oseltamivir phosphate - for suspension; oral)



  • Manufacturer: ROCHE

    Approval date: March 21, 2011

    Strength(s): EQ 6MG BASE/ML [RLD]

Has a generic version of Tamiflu been approved?


No. There is currently no therapeutically equivalent version of Tamiflu available.


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




  • Carbocyclic compounds
    Patent 5,763,483
    Issued: June 9, 1998
    Inventor(s): Bischofberger; Norbert W. & Kim; Choung U. & Lew; Willard & Liu; Hongtao & Williams; Matthew A.
    Assignee(s): Gilead Sciences, Inc.
    Novel carbocyclic compounds are described. The compounds generally comprise an acidic group, a basic group, a substituted amino or N-acyl and a group having an optionally hydroxylated alkane moiety. Pharmaceutical compositions comprising the inhibitors of the invention are also described. Methods of inhibiting neuraminidase in samples suspected of containing neuraminidase are also described. Antigenic materials, polymers, antibodies, conjugates of the compounds of the invention with labels, and assay methods for detecting neuraminidase activity are also described.
    Patent expiration dates:

    • December 27, 2016
      ✓ 
      Patent use: TREATMENT AND PROPHYLAXIS OF INFLUENZA
      ✓ 
      Drug substance


    • December 27, 2016
      ✓ 
      Patent use: TREATMENT OF INFLUENZA
      ✓ 
      Drug substance


    • December 27, 2016
      ✓ 
      Patent use: TREATMENT AND PROPHYLAXIS OF INFLUENZA
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • June 27, 2017
      ✓ 
      Pediatric exclusivity




  • Carbocyclic compounds
    Patent 5,866,601
    Issued: February 2, 1999
    Inventor(s): Lew; Willard & Kim; Choung U. & Liu; Hongtao & Williams; Matthew A.
    Assignee(s): Gilead Sciences, Inc.
    Novel carbocyclic compounds are described. The compounds generally comprise an acidic group, a basic group, a substituted amino or N-acyl and a group having an optionally hydroxylated alkane moiety. Pharmaceutical compositions comprising the inhibitors of the invention are also described. Methods of inhibiting neuraminidase in samples suspected of containing neuraminidase are also described. Antigenic materials, polymers, antibodies, conjugates of the compounds of the invention with labels, and assay methods for detecting neuraminidase activity are also described.
    Patent expiration dates:

    • February 2, 2016
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • August 2, 2016
      ✓ 
      Pediatric exclusivity




  • Compounds and methods for synthesis and therapy
    Patent 5,952,375
    Issued: September 14, 1999
    Inventor(s): Bischofberger; Norbert W. & Kim; Choung U. & Lew; Willard & Liu; Hongtao & Williams; Matthew A.
    Assignee(s): Gilead Sciences, Inc.
    Novel compounds are described. The compounds generally comprise an acidic group, a basic group, a substituted amino or N-acyl and a group having an optionally hydroxylated alkane moiety. Pharmaceutical compositions comprising the inhibitors of the invention are also described. Methods of inhibiting neuraminidase in samples suspected of containing neuraminidase are also described. Antigenic materials, polymers, antibodies, conjugates of the compounds of the invention with labels, and assay methods for detecting neuraminidase activity are also described.
    Patent expiration dates:

    • February 27, 2015
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • August 27, 2015
      ✓ 
      Pediatric exclusivity



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:
    • February 22, 2013 - LABELING CHANGES BASED ON DATA FROM CLINICAL STUDIES NV20235 AND NV20236 STUDIES OF SEASONAL PROPHYLAXIS OF INFLUENZA IN IMMUNOCOMPROMISED PATIENTS AND CHILDREN AGES 1-12

See also...

  • Tamiflu Consumer Information (Drugs.com)
  • Tamiflu Consumer Information (Wolters Kluwer)
  • Tamiflu Suspension Consumer Information (Wolters Kluwer)
  • Tamiflu Consumer Information (Cerner Multum)
  • Tamiflu Advanced Consumer Information (Micromedex)
  • Tamiflu AHFS DI Monographs (ASHP)
  • Oseltamivir Consumer Information (Drugs.com)
  • Oseltamivir Consumer Information (Wolters Kluwer)
  • Oseltamivir Suspension Consumer Information (Wolters Kluwer)
  • Oseltamivir Consumer Information (Cerner Multum)
  • Oseltamivir Advanced Consumer Information (Micromedex)
  • Oseltamivir Phosphate AHFS DI Monographs (ASHP)

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