Generic Rythmol SR Availability
See also: Generic Rythmol
RYTHMOL SR (propafenone hydrochloride - capsule, extended release; oral)
Manufacturer: GLAXOSMITHKLINE LLC
Approval date: September 4, 2003
Strength(s): 225MG [AB], 325MG [AB], 425MG [RLD] [AB]
Has a generic version of Rythmol SR been approved?
A generic version of Rythmol SR 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 Rythmol SR and have been approved by the FDA:
Manufacturer: PAR PHARM
Approval date: October 18, 2010
Strength(s): 225MG [AB], 325MG [AB], 425MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Rythmol SR. 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.
Delayed release microtablet of .beta.-phenylpropiophenone derivatives
Issued: October 28, 1997
Inventor(s): Kolter; Karl & Fricke; Helmut & Buehler; Volker & Mueller-Peltzer; Herbert
Assignee(s): Knoll Aktiengesellschaft
A cylindrical delayed release tablet with a convex or flat upper side and lower side is provided, along with a method for its production and a gelatin capsule containing 3-200 tablets of the same having identical or different release rates, wherein the tablet if made of .beta.-phenylpropiophenone derivatives of the formula I as active ingredient ##STR1## where R is n-propyl or 1,1-dimethylpropyl, and their pharmacologically acceptable salts, wherein the tablet has a height and diameter that are both, independently of one another, 1-3 mm, the active ingredient content is in the range from 81-99.9% of the weight of the microtablet, (but not taking into account the weight of any coating which is present, the active ingredient density is greater than 1, the release of active ingredient in the USP paddle method at 50 rpm is 80% as a maximum after 3 hours and as a minimum after 24 hours, the release rate is virtually independent of the pressure when compressing the tablets, and the tablet contains no release-delaying ancillary substance but can contain 0.1-5% by weight of a lubricant and 0-18.9% by weight of other conventional ancillary substances.Patent expiration dates:
- October 28, 2014
- October 28, 2014
- Rythmol SR sustained-release capsules Consumer Information (Wolters Kluwer)
- Rythmol SR Consumer Information (Cerner Multum)
- Rythmol SR Advanced Consumer Information (Micromedex)
- Propafenone Consumer Information (Wolters Kluwer)
- Propafenone sustained-release capsules Consumer Information (Wolters Kluwer)
- Propafenone Consumer Information (Cerner Multum)
- Propafenone Advanced Consumer Information (Micromedex)
- Propafenone Hydrochloride 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.|
|AB||Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.|