Wednesday, October 26, 2016

Zoloft


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


ZOLOFT (sertraline hydrochloride - concentrate; oral)



  • Manufacturer: PFIZER

    Approval date: December 7, 1999

    Strength(s): EQ 20MG BASE/ML [RLD][AA]

ZOLOFT (sertraline hydrochloride - tablet; oral)



  • Manufacturer: PFIZER

    Approval date: December 30, 1991

    Strength(s): EQ 100MG BASE [RLD][AB], EQ 50MG BASE [AB]


  • Manufacturer: PFIZER

    Approval date: March 6, 1996

    Strength(s): EQ 25MG BASE [AB]

Has a generic version of Zoloft been approved?


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


sertraline hydrochloride concentrate; oral



  • Manufacturer: AUROBINDO PHARMA

    Approval date: October 31, 2008

    Strength(s): EQ 20MG BASE/ML [AA]


  • Manufacturer: RANBAXY

    Approval date: February 5, 2007

    Strength(s): EQ 20MG BASE/ML [AA]

sertraline hydrochloride tablet; oral



  • Manufacturer: APOTEX INC

    Approval date: February 6, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: AUROBINDO PHARMA

    Approval date: February 6, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: AUSTARPHARMA LLC

    Approval date: March 4, 2009

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: DR REDDYS LABS LTD

    Approval date: April 30, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: HIKMA PHARMS

    Approval date: August 10, 2009

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: INVAGEN PHARMS

    Approval date: February 6, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: LUPIN

    Approval date: February 6, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: MATRIX LABS LTD

    Approval date: January 31, 2008

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: MYLAN

    Approval date: February 6, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: MYLAN

    Approval date: March 20, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: RANBAXY

    Approval date: February 6, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: SUN PHARM INDS (IN)

    Approval date: February 6, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: TEVA

    Approval date: August 11, 2006

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: TORRENT PHARMS

    Approval date: February 6, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: WATSON LABS

    Approval date: February 6, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: WOCKHARDT

    Approval date: January 8, 2008

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]


  • Manufacturer: ZYDUS PHARMS USA

    Approval date: February 6, 2007

    Strength(s): EQ 100MG BASE [AB], EQ 25MG BASE [AB], EQ 50MG BASE [AB]

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




  • Sertraline polymorph
    Patent 5,248,699
    Issued: September 28, 1993
    Inventor(s): Sysko; Robert J. & Allen; Douglas J. M.
    Assignee(s): Pfizer Inc.
    This invention relates to a novel crystalline polymorphic form of sertraline hydrochloride, (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4 -tetrahydro-N-methyl-1-naphthalenamine hydrochloride, and to a method for preparing it.
    Patent expiration dates:

    • August 13, 2012


    • February 13, 2013
      ✓ 
      Pediatric exclusivity




  • Sertraline oral concentrate
    Patent 6,727,283
    Issued: April 27, 2004
    Inventor(s): Nancy J.; Harper & Gautam R.; Ranade & Willard M.; Welch
    Assignee(s): Pfizer Inc.
    The present invention provides an essentially nonaqueous, liquid pharmaceutical concentrate composition for oral administration containing sertraline or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients. The present invention also provides a use of this concentrate composition to prepare an aqueous solution of sertraline. In addition, the present invention provides a method of using this concentrate composition to treat or prevent a variety of diseases or conditions. Finally, the present invention provides the compound, (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine methanesulfonate.
    Patent expiration dates:

    • October 11, 2019
      ✓ 
      Patent use: TREATMENT OF DISORDERS OF THE SEROTONERGIC SYSTEM SUCH AS DEPRESSION AND ANXIETY-RELATED DISORDERS
      ✓ 
      Drug product


    • April 11, 2020
      ✓ 
      Pediatric exclusivity




  • Sertraline oral concentrate
    Patent 7,067,555
    Issued: June 27, 2006
    Inventor(s): Harper; Nancy J. & Ranade; Gautam R. & Welch; Willard M.
    Assignee(s): Pfizer Inc
    The present invention provides an essentially nonaqueous, liquid pharmaceutical concentrate composition for oral administration containing sertraline or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients. The present invention also provides a use of this concentrate composition to prepare an aqueous solution of sertraline. In addition, the present invention provides a method of using this concentrate composition to treat or prevent a variety of diseases or conditions. Finally, the present invention provides the compound, (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine methanesulfonate.
    Patent expiration dates:

    • November 10, 2019
      ✓ 
      Drug product


    • May 10, 2020
      ✓ 
      Pediatric exclusivity



See also...

  • Zoloft Consumer Information (Drugs.com)
  • Zoloft Consumer Information (Wolters Kluwer)
  • Zoloft Concentrate Consumer Information (Wolters Kluwer)
  • Zoloft Consumer Information (Cerner Multum)
  • Zoloft Advanced Consumer Information (Micromedex)
  • Zoloft AHFS DI Monographs (ASHP)
  • Sertraline Consumer Information (Drugs.com)
  • Sertraline Consumer Information (Wolters Kluwer)
  • Sertraline Concentrate Consumer Information (Wolters Kluwer)
  • Sertraline Consumer Information (Cerner Multum)
  • Sertraline Advanced Consumer Information (Micromedex)
  • Sertraline Hydrochloride AHFS DI Monographs (ASHP)
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