Generic Paxil Availability

See also: Generic Paxil CR

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

PAXIL (paroxetine hydrochloride - suspension;oral)

  • Manufacturer: APOTEX TECHNOLOGIES
    Approval date: June 25, 1997
    Strength(s): EQ 10MG BASE/5ML [RLD] [AB]

PAXIL (paroxetine hydrochloride - tablet;oral)

  • Manufacturer: APOTEX TECHNOLOGIES
    Approval date: December 29, 1992
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 40MG BASE [RLD] [AB]

Has a generic version of Paxil been approved?

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

paroxetine hydrochloride tablet;oral

  • Manufacturer: APOTEX
    Approval date: July 30, 2003
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: July 25, 2007
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: March 13, 2008
    Strength(s): EQ 40MG BASE [AB], EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 30MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: March 8, 2004
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: PROSAM LABS
    Approval date: June 21, 2010
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: SUN PHARM INDS INC
    Approval date: June 29, 2007
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: TEVA
    Approval date: August 15, 2005
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 40MG BASE [AB]
  • Manufacturer: ZYDUS PHARMS USA
    Approval date: March 7, 2007
    Strength(s): EQ 10MG BASE [AB], EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 40MG BASE [AB]

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

  • paroxetine hydrochloride - suspension;oral

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

  • Oral liquid compositions containing paroxetine resinate
    Patent 5,811,436
    Issued: September 22, 1998
    Inventor(s): Leonard; Graham Stanley & Cooper; David
    Assignee(s): SmithKline Beecham plc
    An oral liquid pharmaceutical composition comprising a paroxetine-Amberlite IRP88 complex.
    Patent expiration dates:
    • September 22, 2015
    • March 22, 2016
      ✓ 
      Pediatric exclusivity
  • Form of paroxetine hydrochloride anhydrate
    Patent 5,872,132
    Issued: February 16, 1999
    Inventor(s): Ward; Neal & Jacewicz; Victor Witold
    Assignee(s): SmithKline Beecham Corporation
    "Paroxetine hydrochloride (I) anhydrate ##STR1## free of bound propan-2-ol, and various forms thereof, are useful in the treatment of depression and other disorders for which administration of selective serotonin reuptake inhibitors are indicated."
    Patent expiration dates:
    • May 19, 2015
    • November 19, 2015
      ✓ 
      Pediatric exclusivity
  • Form of paroxetine hydrochloride anhydrate
    Patent 5,900,423
    Issued: May 4, 1999
    Inventor(s): Ward; Neal & Jacewicz; Victor Witold
    Assignee(s): SmithKline Beecham Corporation
    "Paroxetine hydrochloride (I) anhydrate ##STR1## free of bound propan-2-ol, and various forms thereof, are useful in the treatment of depression and other disorders for which administration of selective serotonin reuptake inhibitors are indicated."
    Patent expiration dates:
    • May 19, 2015
    • November 19, 2015
      ✓ 
      Pediatric exclusivity
  • Paroxetine derivatives
    Patent 6,063,927
    Issued: May 16, 2000
    Inventor(s): Craig; Andrew Simon & Jones; Alan David & O'Keeffe; Deirdre & Ward; Neal
    Assignee(s): SmithKline Beecham plc
    Piperidine compounds, processes for preparing them, pharmaceutical compositions comprising them and their use in therapy are disclosed.
    Patent expiration dates:
    • April 23, 2019
    • October 23, 2019
      ✓ 
      Pediatric exclusivity
  • Paroxetine hydrochloride form A
    Patent 6,080,759
    Issued: June 27, 2000
    Inventor(s): Ward; Neal & Jacewicz; Victor Witold
    Assignee(s): SmithKline Beecham Corporation
    "Paroxetine hydrochloride (I) anhydrate free of bound propan-2-ol, and various forms thereof, are useful in the treatment of depression and other disorders for which administration of selective serotonin reuptake inhibitors are indicated."
    Patent expiration dates:
    • May 19, 2015
    • November 19, 2015
      ✓ 
      Pediatric exclusivity
  • Paroxetine tablets and process to prepare them
    Patent 6,113,944
    Issued: September 5, 2000
    Inventor(s): Pathak; Ram Dutta & Doughty; David George
    Assignee(s): SmithKline Beecham p.l.c.
    Invented is a novel pharmaceutical composition containing Paroxetine.
    Patent expiration dates:
    • December 14, 2014
    • June 14, 2015
      ✓ 
      Pediatric exclusivity
  • Paroxetine in the treatment of depression associated with withdrawal from heroin abuse and post-traumatic stress disorder
    Patent 6,121,291
    Issued: September 19, 2000
    Inventor(s): Gleason; Maurice
    Assignee(s): SmithKline Beecham plc
    This invention relates to the use of paroxetine or a pharmaceutically acceptable salt thereof for the treatment of post-traumatic stress disorder and depression associated with withdrawal from heroin abuse.
    Patent expiration dates:
    • March 17, 2017
      ✓ 
      Patent use: POSTTRAUMATIC STRESS DISORDER
    • March 17, 2017
      ✓ 
      Patent use: DEPRESSION
    • September 17, 2017
      ✓ 
      Pediatric exclusivity
  • Paroxetine hydrochloride form A or C
    Patent 6,133,289
    Issued: October 17, 2000
    Inventor(s): Ward; Neal & Jacewicz; Victor Witold
    Assignee(s): SmithKline Beecham Corporation
    Invented are methods of treatment using novel forms of paroxetine hydrochloride anhydrate.
    Patent expiration dates:
    • May 19, 2015
      ✓ 
      Patent use: DEPRESSION, OBSESSIVE COMPULSIVE DISORDER, PANIC DISORDER AND SOCIAL ANXIETY DISORDER
    • November 19, 2015
      ✓ 
      Pediatric exclusivity
  • Process for making paroxetine
    Patent 6,172,233
    Issued: January 9, 2001
    Inventor(s): Ward; Neal
    Assignee(s): SmithKline Beecham plc
    Compounds of structure (2) are prepared by reaction of an arecoline analogue of structure(4) with an organometallic compound containing an X-substituted phenyl group, such as a compound of structure (3). ##STR1## Suitably the compound of structure (3) is a Grignard reagent, where M is magnesium and Y is a halogen atom, or M may be a Group II metal and Y is a halogen atom or a second X-substituted phenyl group. When structure (3) is a Grignard reagent, the reaction is carried out either in a suitable non-ether solvent, typically a hydrocarbon or a non-reactive chlorinated hydrocarbon, or in a mixture of such a solvent with diethyl ether. Compounds of structure (2) are important intermediates in the preparation of inter alia paroxetine.
    Patent expiration dates:
    • January 15, 2018
    • July 15, 2018
      ✓ 
      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.
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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