Generic Risperdal Availability

See also: Generic Risperdal Consta

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

RISPERDAL (risperidone - solution;oral)

RISPERDAL (risperidone - tablet, orally disintegrating;oral)

RISPERDAL (risperidone - tablet;oral)

  • Manufacturer: JANSSEN PHARMS
    Approval date: December 29, 1993
    Strength(s): 1MG [RLD] [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: JANSSEN PHARMS
    Approval date: January 27, 1999
    Strength(s): 0.5MG [AB]
  • Manufacturer: JANSSEN PHARMS
    Approval date: May 10, 1999
    Strength(s): 0.25MG [AB]

Has a generic version of Risperdal been approved?

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

risperidone solution;oral

  • Manufacturer: AMNEAL PHARMS
    Approval date: May 25, 2011
    Strength(s): 1MG/ML [AA]
  • Manufacturer: ANI PHARMS INC
    Approval date: January 30, 2009
    Strength(s): 1MG/ML [AA]
  • Manufacturer: APOTEX INC
    Approval date: July 29, 2009
    Strength(s): 1MG/ML [AA]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: September 4, 2009
    Strength(s): 1MG/ML [AA]
  • Manufacturer: BIO PHARM INC
    Approval date: July 29, 2009
    Strength(s): 1MG/ML [AA]
  • Manufacturer: PRECISION DOSE
    Approval date: June 28, 2010
    Strength(s): 1MG/ML [AA]
  • Manufacturer: ROXANE
    Approval date: July 29, 2009
    Strength(s): 1MG/ML [AA]
  • Manufacturer: TARO
    Approval date: February 7, 2011
    Strength(s): 1MG/ML [AA]
  • Manufacturer: TRIS PHARMA INC
    Approval date: December 12, 2012
    Strength(s): 1MG/ML [AA]
  • Manufacturer: VINTAGE
    Approval date: December 3, 2010
    Strength(s): 1MG/ML [AA]
  • Manufacturer: WOCKHARDT
    Approval date: October 8, 2009
    Strength(s): 1MG/ML [AA]

risperidone tablet, orally disintegrating;oral

  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: April 19, 2011
    Strength(s): 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: February 24, 2009
    Strength(s): 0.5MG [AB], 2MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: October 5, 2009
    Strength(s): 1MG [AB]
  • Manufacturer: JUBILANT GENERICS
    Approval date: November 4, 2011
    Strength(s): 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: March 30, 2011
    Strength(s): 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: PAR PHARM
    Approval date: April 30, 2009
    Strength(s): 0.5MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: PAR PHARM
    Approval date: October 26, 2009
    Strength(s): 1MG [AB]
  • Manufacturer: RANBAXY
    Approval date: August 6, 2010
    Strength(s): 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: SANDOZ
    Approval date: December 22, 2009
    Strength(s): 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: SUN PHARM INDS LTD
    Approval date: April 8, 2013
    Strength(s): 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: TEVA
    Approval date: March 12, 2012
    Strength(s): 0.5MG [AB], 1MG [AB], 2MG [AB]
  • Manufacturer: ZYDUS PHARMS USA
    Approval date: May 1, 2009
    Strength(s): 0.5MG [AB], 2MG [AB]

risperidone tablet;oral

  • Manufacturer: AJANTA PHARMA LTD
    Approval date: August 24, 2011
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: APOTEX INC
    Approval date: September 15, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: October 8, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: CIPLA
    Approval date: May 18, 2011
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: October 24, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: MYLAN
    Approval date: September 15, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: PLIVA HRVATSKA DOO
    Approval date: October 16, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: PRINSTON INC
    Approval date: November 29, 2011
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: PROSAM LABS
    Approval date: June 17, 2009
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: SANDOZ
    Approval date: October 16, 2009
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: SUN PHARM INDS INC
    Approval date: March 10, 2014
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: TEVA
    Approval date: June 30, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: TORRENT PHARMS
    Approval date: October 30, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: VINTAGE
    Approval date: December 29, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: WATSON LABS
    Approval date: December 5, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: WOCKHARDT
    Approval date: October 9, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: October 16, 2008
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]

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

  • Risperidone oral formulation
    Patent 5,453,425
    Issued: September 26, 1995
    Inventor(s): Francois; Marc K. J. & Dries; Willy M. A. C.
    Assignee(s): Janssen Pharmaceutica N.V.
    The present invention is concerned with physicochemically stable aqueous solutions of risperidone for oral administration which do not contain sorbitol.
    Patent expiration dates:
    • July 11, 2014
      ✓ 
      Drug product
    • January 11, 2015
      ✓ 
      Pediatric exclusivity
  • Pharmaceutical and other dosage forms
    Patent 5,648,093
    Issued: July 15, 1997
    Inventor(s): Gole; Dilip J. & Levinson; R. Saul & Wilkinson; Paul K. & Davies; J. Desmond
    Assignee(s): Janssen Pharmaceutica Inc.
    A fast dissolving, solid dosage form defined by a matrix containing gelatin, pectin and/or soy fiber protein and one or more amino acids having from about 2 to 12 carbon atoms is disclosed.
    Patent expiration dates:
    • July 15, 2014
      ✓ 
      Drug product
    • January 15, 2015
      ✓ 
      Pediatric exclusivity
  • Biconvex rapidly disintegrating dosage forms
    Patent 6,224,905
    Issued: May 1, 2001
    Inventor(s): Lawrence; Janice & Posage; Gary
    Assignee(s): Janssen Pharmaceutica N.V.
    A method for preparing solid rapidly disintegrating dosage forms shaped as biconvex tablets having symmetrical top and bottom surfaces and dosage forms obtainable thereby.
    Patent expiration dates:
    • June 10, 2017
      ✓ 
      Drug product
    • December 10, 2017
      ✓ 
      Pediatric exclusivity
  • Aqueous risperidone formulations
    Patent RE39181
    Issued: July 11, 2006
    Inventor(s): François; Marc Karel Jozef & Dries; Willy Maria Albert Carlo
    The present invention is concerned with physicochemically stable aqueous solutions of risperidone for oral and parenteral administration; processes for preparing such formulations.
    Patent expiration dates:
    • July 11, 2014
      ✓ 
      Drug product
    • January 11, 2015
      ✓ 
      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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