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Generic Sabril Availability

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

SABRIL (vigabatrin - for solution;oral)

  • Manufacturer: LUNDBECK PHARMS LLC
    Approval date: August 21, 2009
    Strength(s): 500MG/PACKET [RLD] [AA]

SABRIL (vigabatrin - tablet;oral)

  • Manufacturer: LUNDBECK PHARMS LLC
    Approval date: August 21, 2009
    Strength(s): 500MG [RLD]

Has a generic version of Sabril been approved?

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

vigabatrin for solution;oral

  • Manufacturer: PAR PHARM INC
    Approval date: April 27, 2017
    Strength(s): 500MG/PACKET [AA]

Note: No generic formulation of the following product is available.

  • vigabatrin - tablet;oral

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

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 21, 2016 - ORPHAN DRUG EXCLUSIVITY
    • October 26, 2016 - NEW PATIENT POPULATION
    • February 21, 2017 - PEDIATRIC EXCLUSIVITY
    • April 26, 2017 - PEDIATRIC EXCLUSIVITY
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.