Wednesday, September 21, 2016

Famvir


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


FAMVIR (famciclovir - tablet; oral)



  • Manufacturer: NOVARTIS

    Approval date: June 29, 1994

    Strength(s): 500MG [RLD][AB]


  • Manufacturer: NOVARTIS

    Approval date: December 11, 1995

    Strength(s): 125MG [AB]


  • Manufacturer: NOVARTIS

    Approval date: April 26, 1996

    Strength(s): 250MG [AB]

Has a generic version of Famvir been approved?


A generic version of Famvir 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 Famvir and have been approved by the FDA:


famciclovir tablet; oral



  • Manufacturer: APOTEX

    Approval date: July 22, 2011

    Strength(s): 125MG [AB], 250MG [AB], 500MG [AB]


  • Manufacturer: AUROBINDO PHARMA LTD

    Approval date: March 21, 2011

    Strength(s): 125MG [AB], 250MG [AB], 500MG [AB]


  • Manufacturer: MACLEODS PHARMS LTD

    Approval date: January 12, 2012

    Strength(s): 125MG [AB], 250MG [AB], 500MG [AB]


  • Manufacturer: MYLAN

    Approval date: March 24, 2011

    Strength(s): 125MG [AB], 250MG [AB], 500MG [AB]


  • Manufacturer: ROXANE

    Approval date: March 21, 2011

    Strength(s): 125MG [AB], 250MG [AB], 500MG [AB]


  • Manufacturer: TEVA PHARMS

    Approval date: August 24, 2007

    Strength(s): 125MG [AB], 250MG [AB], 500MG [AB]


  • Manufacturer: WATSON LABS

    Approval date: March 21, 2011

    Strength(s): 125MG [AB], 250MG [AB], 500MG [AB]

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




  • Treatment of a latent infection of herpes viruses
    Patent 5,840,763
    Issued: November 24, 1998
    Inventor(s): Field; Hugh John & Thackray; Alana Maureen & Bacon; Teresa Helen & Sutton; David & Vere Hodge; Richard Anthony
    Assignee(s): SmithKline Beecham plc
    A method for the treatment of latent infection of herpesviruses in mammals, including humans, which method comprises administering to the mammal in need of such treatment, an effective amount of a compound of formula (A): ##STR1## or a bioprecursor, or a pharmaceutically acceptable salt, phosphate ester and/or acyl derivative of either of the foregoing.
    Patent expiration dates:

    • September 1, 2015
      ✓ 
      Patent use: METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS


    • March 1, 2016
      ✓ 
      Pediatric exclusivity




  • Penciclovir for the treatment of post therapeutic neuralgia
    Patent 5,866,581
    Issued: February 2, 1999
    Inventor(s): Boon; Ronald James & Griffin; David Ronald John
    Assignee(s): SmithKline Beecham p.l.c.
    A method for the treatment of PHN in mammals, including humans, which method comprises administering an effective amount of a compound of formula (A), or a pharmaceutically acceptable salt thereof. ##STR1##
    Patent expiration dates:

    • October 4, 2014
      ✓ 
      Patent use: METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS


    • April 4, 2015
      ✓ 
      Pediatric exclusivity




  • Treatment of a latent infection of herpes virus
    Patent 5,916,893
    Issued: June 29, 1999
    Inventor(s): Field; Hugh John & Thackray; Alana Maureen & Bacon; Teresa Helen & Sutton; David & Vere Hodge; Richard Anthony
    Assignee(s): SmithKline Beecham p.l.c.
    A method for the treatment of latent infection of herpesviruses in mammals, including humans, which method comprises administering to the mammal in need of such treatment, an effective amount of a compound of formula (A): ##STR1## or a bioprecursor, or a pharmaceutically acceptable salt, phosphate ester and/or acyl derivative of either of the foregoing.
    Patent expiration dates:

    • September 1, 2015
      ✓ 
      Patent use: METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS


    • March 1, 2016
      ✓ 
      Pediatric exclusivity




  • Penciclovir for the treatment of zoster associated pain
    Patent 6,124,304
    Issued: September 26, 2000
    Inventor(s): Boon; Ronald James & Griffin; David Ronald John
    Assignee(s): SmithKline Beecham PLC
    A method for the treatment of ZAP, in particular PHN, in mammals, including humans, which method comprises administering to the mammal in need of such treatment, an effective amount of penciclovir or famciclovir, or a pharmaceutically acceptable salt thereof.
    Patent expiration dates:

    • October 4, 2014
      ✓ 
      Patent use: METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS


    • April 4, 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:
    • December 24, 2012 - INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL

    • June 24, 2013 - PEDIATRIC EXCLUSIVITY

    • January 31, 2014 - NEW INFORMATION FROM A STUDY WHICH EVALUATED THE SAFETY AND EFFICACY OF FAMVIR IN TREATING RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT BLACK/AFRICAN AMERICAN SUBJECTS.

See also...

  • Famvir Consumer Information (Drugs.com)
  • Famvir Consumer Information (Wolters Kluwer)
  • Famvir Consumer Information (Cerner Multum)
  • Famvir Advanced Consumer Information (Micromedex)
  • Famvir AHFS DI Monographs (ASHP)
  • Famciclovir Consumer Information (Wolters Kluwer)
  • Famciclovir Consumer Information (Cerner Multum)
  • Famciclovir Advanced Consumer Information (Micromedex)
  • Famciclovir AHFS DI Monographs (ASHP)

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