Generic Xenical Availability
XENICAL (orlistat - capsule;oral)
Manufacturer: HOFFMANN LA ROCHE
Approval date: April 23, 1999
Strength(s): 120MG [RLD]
Has a generic version of Xenical been approved?
No. There is currently no therapeutically equivalent version of Xenical available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xenical. 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.
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.
Tetrahydrolipstatin containing compositions
Issued: December 21, 1999
Inventor(s): Shah; Navnit Hargovindas & Zeller; Max
Assignee(s): Hoffman-La Roche Inc.
Product containing tetrahydrolipstatin as the active ingredient and pharmaceutically acceptable excipients, characterized in that it is in the form of particles with a diameter of 0.25 to 2 mm; and pharmaceutical preparation s or compositions for oral administration containing the product.Patent expiration dates:
- January 6, 2018
- July 6, 2018✓
- January 6, 2018
- Xenical Consumer Information (Drugs.com)
- Xenical Consumer Information (Wolters Kluwer)
- Xenical Consumer Information (Cerner Multum)
- Xenical Advanced Consumer Information (Micromedex®)
- Xenical AHFS DI Monographs (ASHP)
- Orlistat Consumer Information (Drugs.com)
- Orlistat Consumer Information (Wolters Kluwer)
- Orlistat Consumer Information (Cerner Multum)
- Orlistat Advanced Consumer Information (Micromedex®)
- Orlistat AHFS DI Monographs (ASHP)
|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.|