Generic Suprep Bowel Prep Kit Availability
Last updated on Mar 9, 2023.
Suprep Bowel Prep Kit is a brand name of magnesium sulfate/potassium sulfate/sodium sulfate, approved by the FDA in the following formulation(s):
SUPREP BOWEL PREP KIT (magnesium sulfate; potassium sulfate; sodium sulfate - solution;oral)
Manufacturer: BRAINTREE LABS
Approval date: August 5, 2010
Strength(s): 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT [RLD] [AA]
Has a generic version of Suprep Bowel Prep Kit been approved?
A generic version of Suprep Bowel Prep Kit 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 Suprep Bowel Prep Kit and have been approved by the FDA:
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE (magnesium sulfate; potassium sulfate; sodium sulfate solution;oral)
Manufacturer: NOVEL LABS INC
Approval date: February 23, 2017
Strength(s): 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT [AA]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Suprep Bowel Prep Kit. 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.
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.
Salt solution for colon cleansing
Issued: September 20, 2005
Inventor(s): Cleveland; Mark vB.
Assignee(s): Braintree Laboratories, Inc.
The field of colonic diagnostic and surgical procedures is hampered by the lack of optimal means available to cleanse the colon. A compromise between convenient, distasteful, solid or low volume, hyperosmotic solutions which cause considerable fluid and electrolyte imbalances in patients and large volume, difficult to consume, iso-osmotic solutions has had to be made heretofore. This invention describes a low volume, hyper-osmotic solution consisting of sulfate salts with and with out polyethylene glycol. Unlike prior art, this composition is useful for the cleansing of the bowel and, in lower volumes, as a laxative, without producing clinically significant changes in bodily function.
Patent expiration dates:
- March 7, 2023✓✓
- March 7, 2023
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 5, 2027 - FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
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|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.|
|AA||Products 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.|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.