Generic Invega Sustenna Availability
INVEGA SUSTENNA (paliperidone palmitate - suspension, extended release;intramuscular)
Manufacturer: JANSSEN PHARMS
Approval date: July 31, 2009
Strength(s): 39MG/0.25ML (39MG/0.25ML) [RLD], 78MG/0.5ML (78MG/0.5ML) [RLD], 117MG/0.75ML (117MG/0.75ML) [RLD], 156MG/ML (156MG/ML) [RLD], 234MG/1.5ML (156MG/ML) [RLD]
Has a generic version of Invega Sustenna been approved?
No. There is currently no therapeutically equivalent version of Invega Sustenna available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Invega Sustenna. 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: Generic Drug FAQs.
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.
Aqueous suspensions of submicron 9-hydroxyrisperidone fatty acid esters
Issued: April 29, 2003
Inventor(s): Marc Karel Jozef; François & Willy Maria Albert Carlo; Dries & Esther Dina Guido; Basstanie
Assignee(s): Janssen Pharmaceutica, N.V.
The present invention is concerned with a pharmaceutical composition suitable as a depot formulation for administration via intramuscular or subcutaneous injection, comprising: (1) as an active ingredient a therapeutically effective amount of a 9-hydroxy-risperidone fatty acid ester or a salt, or a stereoisomer or a stereoisomeric mixture thereof in submicron form and (2) a pharmaceutically acceptable carrier; wherein the pharmaceutically acceptable carrier is water and the active ingredient is suspended therein: and with a process of preparing such a composition. The invention further concerns such a pharmaceutical composition for use as a medicament in the treatment of psychosis, schizophrenia, schizoaffective disorders, non-schizophrenic psychoses, behavioural disturbances associated with neurodegenerative disorders, e.g. in dementia, behavioural disturbances in mental retardation and autism, Tourette's syndrome, bipolar mania, depression, anxiety.Patent expiration dates:
- November 10, 2018✓✓
- May 10, 2019✓
- November 10, 2018
Dosing regimen associated with long acting injectable paliperidone esters
Issued: September 13, 2016
Assignee(s): Janssen Pharmaceutica NV
The present invention provides a method of treating patients in need of treatment with long acting injectable paliperidone palmitate formulations.Patent expiration dates:
- January 26, 2031✓
- January 26, 2031✓
- January 26, 2031
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:
- December 20, 2020 - INFORMATION ADDED TO THE LABELING REGARDING THE COMPARISON OF PALIPERIDONE PALMITATE COMPARED WITH ORAL ANTIPSYCHOTIC TREATMENT IN DELAYING TIME TO TREATMENT FAILURE IN ADULTS WITH SCHIZOPHRENIA WHO HAVE BEEN INCARCERATED
More about Invega Sustenna (paliperidone)
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- 39 Reviews – Add your own review/rating
- Drug class: atypical antipsychotics
Other brands: Invega Trinza
Related treatment guides
|Drug Patent||A 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 Exclusivity||Exclusivity 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.|
|RLD||A 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.|