Generic Zoloft Availability

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 50MG BASE [AB], EQ 100MG BASE [RLD] [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]

sertraline hydrochloride tablet;oral

  • Manufacturer: APOTEX INC
    Approval date: February 6, 2007
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: February 6, 2007
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: AUSTARPHARMA LLC
    Approval date: March 4, 2009
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: HIKMA PHARMS
    Approval date: August 10, 2009
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: INVAGEN PHARMS
    Approval date: February 6, 2007
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: LUPIN
    Approval date: February 6, 2007
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: February 6, 2007
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: January 31, 2008
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: PROSAM LABS
    Approval date: July 21, 2010
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: RANBAXY
    Approval date: February 6, 2007
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: SUN PHARM INDS (IN)
    Approval date: February 6, 2007
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: TEVA
    Approval date: August 11, 2006
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: TORRENT PHARMS
    Approval date: February 6, 2007
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: WATSON LABS
    Approval date: February 6, 2007
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: WOCKHARDT
    Approval date: January 8, 2008
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG BASE [AB]
  • Manufacturer: ZYDUS PHARMS USA
    Approval date: February 6, 2007
    Strength(s): EQ 25MG BASE [AB], EQ 50MG BASE [AB], EQ 100MG 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 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:
    • October 11, 2019
      ✓ 
      Drug product
    • April 11, 2020
      ✓ 
      Pediatric exclusivity

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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