Generic Opipza Availability
Last updated on Apr 10, 2025.
Opipza is a brand name of aripiprazole, approved by the FDA in the following formulation(s):
OPIPZA (aripiprazole - film;oral)
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Manufacturer: XIAMEN LP PHARM CO
Approval date: July 22, 2024
Strength(s): 2MG [RLD], 5MG [RLD], 10MG [RLD]
Is there a generic version of Opipza available?
No. There is currently no therapeutically equivalent version of Opipza available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Opipza. 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 FAQ.
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.
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Aripiprazole oral soluble film
Patent 11,331,315
Issued: May 17, 2022
Inventor(s): Ling; Rongbin et al.
Assignee(s): XIAMEN LP PHARMACEUTICAL CO., LTD. (Xiamen, CN)The present invention is directed to an aripiprazole oral soluble film and a preparation method thereof. The aripiprazole oral soluble film comprises 10-60% w/w of aripiprazole in a crystalline state and 30-95% w/w of one or more film-forming materials, wherein 90% of the aripiprazole particles have a size of ≤14.3 μm and are uniformly blended in the film without visible undispersed particles. The aripiprazole oral soluble film has excellent bioavailability, uniformity, stability, and palatability. The oral soluble film preparation is prepared by first grinding aripiprazole particles to have desired small particle sizes, then blending the aripiprazole particles with film forming materials in an aqueous solution to a uniform suspension, defoaming the suspension, and coating the suspension on a substrate and drying it to form a film.
Patent expiration dates:
- November 3, 2040✓
- November 3, 2040
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Process for preparing aripiprazole oral soluble film
Patent 11,701,352
Issued: July 18, 2023
Inventor(s): Ling; Rongbin et al.
Assignee(s): XIAMEN LP PHARMACEUTICAL CO., LTD. (Xiamen, CN)The present invention is directed to an aripiprazole oral soluble film and a preparation method thereof. The aripiprazole oral soluble film comprises 10-60% w/w of aripiprazole in a crystalline state and 30-95% w/w of one or more film-forming materials, wherein 90% of the aripiprazole particles have a size of ≤14.3 μm and are uniformly blended in the film without visible undispersed particles. The aripiprazole oral soluble film has excellent bioavailability, uniformity, stability, and palatability. The oral soluble film preparation is prepared by first grinding aripiprazole particles to have desired small particle sizes, then blending the aripiprazole particles with film forming materials in an aqueous solution to a uniform suspension, defoaming the suspension, and coating the suspension on a substrate and drying it to form a film.
Patent expiration dates:
- December 15, 2041✓
- December 15, 2041
More about Opipza (aripiprazole)
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Glossary
Term | Definition |
---|---|
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. |
Further information
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