Generic HalfLytely and Bisacodyl Availability
HalfLytely and Bisacodyl is a brand name of bisacodyl/polyethylene glycol 3350/potassium chloride/sodium bicarbonate/sodium chloride, approved by the FDA in the following formulation(s):
HALFLYTELY (bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride - for solution, tablet, delayed release;oral)
Approval date: July 16, 2010
Strength(s): 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM [RLD] [AA]
Has a generic version of HalfLytely and Bisacodyl been approved?
A generic version of HalfLytely and Bisacodyl 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 HalfLytely and Bisacodyl and have been approved by the FDA:
PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE, AND BISACODYL (bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride for solution, tablet, delayed release;oral)
Manufacturer: NOVEL LABS INC
Approval date: August 20, 2014
Strength(s): 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM [AA]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of HalfLytely and Bisacodyl. 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.
Method of bowel cleansing
Issued: November 6, 2007
Inventor(s): Dennett, Jr.; Edmund V. & Raleigh, Jr.; Robert M. & Cleveland; Mark V B. & Pelham; Russell W.
Assignee(s): Braintree Laboratories Inc.
Stimulant laxative in combination with an osmotic laxative produces safe and effective bowel and colon cleansing with a reduced volume of liquid input. Administering to a patient an oral stimulant laxative, such as bisacodyl, followed, after a biologically determined interval, by a reduced volume of a PEG in water solution cleanses the bowels and colon in preparation for diagnostic colonoscopy, without the profuse uncontrollable diarrhea that typically follows either ingestion of large volume isotonic ravages, or smaller volume hypertonic lavages.Patent expiration dates:
- October 22, 2022✓
- October 22, 2022
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:
- July 16, 2013 -
- HalfLytely Consumer Information (Drugs.com)
- Bisacodyl Tablets Bowel Prep Kit Consumer Information (Wolters Kluwer)
- HalfLytely solution Consumer Information (Wolters Kluwer)
- Half Lytely and Bisacodyl Lemon Lime Consumer Information (Cerner Multum)
- HalfLytely and Bisacodyl Consumer Information (Cerner Multum)
- HalfLytely and Bisacodyl with Flavor Packs Consumer Information (Cerner Multum)
- Bisacodyl Tablet Bowel Prep Kit solution Consumer Information (Wolters Kluwer)
- Polyethylene glycol/electrolytes solution Consumer Information (Wolters Kluwer)
- Bisacodyl and polyethylene glycol (PEG) 3350 with electrolytes Consumer Information (Cerner Multum)
|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.|