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)
Manufacturer: JANSSEN PHARMS
Approval date: June 10, 1996
Strength(s): 1MG/ML [RLD][AA]
RISPERDAL (risperidone - tablet, orally disintegrating; oral)
Manufacturer: JANSSEN PHARMS
Approval date: April 2, 2003
Strength(s): 0.5MG [AB], 1MG [RLD][AB], 2MG [AB]
Manufacturer: JANSSEN PHARMS
Approval date: December 23, 2004
Strength(s): 3MG [AB], 4MG [AB]
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: 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: DR REDDYS LABS LTD
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: TEVA
Approval date: January 30, 2009
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: 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 ORGANOSYS
Approval date: November 4, 2011
Strength(s): 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
Manufacturer: MYLAN
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: WATSON LABS FLORIDA
Approval date: April 19, 2011
Strength(s): 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [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: SANDOZ
Approval date: October 16, 2009
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: WEST WARD PHARMS
Approval date: May 29, 2009
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✓
- January 11, 2015✓
- July 11, 2014
Aqueous risperidone formulations
Patent 5,616,587
Issued: April 1, 1997
Inventor(s): Fran.cedilla.ois; 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 and parenteral administration; processes for preparing such formulations.Patent expiration dates:
- July 11, 2014✓
- January 11, 2015✓
- July 11, 2014
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✓
- January 15, 2015✓
- July 15, 2014
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✓
- December 10, 2017✓
- June 10, 2017
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✓
- January 11, 2015✓
- July 11, 2014
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:
- August 22, 2010 - TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGES 13-17
- August 22, 2010 - TREATMENT OF BIPOLAR I DISORDER IN CHILDREN AGES 10-12 AND ADOLESCENTS AGES 13-17
- February 22, 2011 - PEDIATRIC EXCLUSIVITY
See also...
- Risperdal Consumer Information (Drugs.com)
- Risperdal Consumer Information (Wolters Kluwer)
- Risperdal Solution Consumer Information (Wolters Kluwer)
- Risperdal Consumer Information (Cerner Multum)
- Risperdal Advanced Consumer Information (Micromedex)
- Risperdal AHFS DI Monographs (ASHP)
- Risperidone Consumer Information (Drugs.com)
- Risperidone Consumer Information (Wolters Kluwer)
- Risperidone Orally Disintegrating Tablets Consumer Information (Wolters Kluwer)
- Risperidone Solution Consumer Information (Wolters Kluwer)
- Risperidone Tablets Consumer Information (Wolters Kluwer)
- Risperidone Consumer Information (Cerner Multum)
- Risperidone Advanced Consumer Information (Micromedex)
- Risperidone Intramuscular Advanced Consumer Information (Micromedex)
- Risperidone AHFS DI Monographs (ASHP)
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