Generic Skelaxin Availability
SKELAXIN (metaxalone - tablet;oral)
Has a generic version of Skelaxin been approved?
A generic version of Skelaxin 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 Skelaxin and have been approved by the FDA:
Manufacturer: AMNEAL PHARMS
Approval date: June 21, 2013
Strength(s): 800MG [AB]
Approval date: March 31, 2010
Strength(s): 800MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Skelaxin. 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.
Metaxalone products, method of manufacture, and method of use
Issued: October 17, 2006
Inventor(s): Du; Jie & Roberts; Richard H.
Assignee(s): Mutual Pharmaceutical Company, Inc.
Disclosed herein is a method of using metaxalone. In one embodiment, the method comprises obtaining metaxalone from a container providing information that metaxalone affects the activity of a cytochrome p450 isozyme. In another embodiment, the method comprises informing a user that metaxalone affects the activity of a cytochrome p450 isozyme. Also included are articles of manufacture comprising a container containing a dosage form of metaxalone, wherein the container is associated with published material informing that metaxalone affects activity of a cytochrome p450 isozyme. Also disclosed are a method of treatment and a method of manufacturing a metaxalone product.Patent expiration dates:
- February 6, 2026✓
- February 6, 2026
Methods of modifying the bioavailability of metaxalone
Issued: May 11, 2010
Inventor(s): Scaife; Michael C. & Davis; Charles C.
Assignee(s): King Pharmaceuticals Research & Development, Inc.
A method of increasing the bioavailability, and decreasing the effect of age on the bioavailability, of metaxalone, by administration of an oral dosage form with food is provided, as well as an article of manufacture comprising an oral dosage form of metaxalone in a suitable container and associated with printed labeling which describes the increased bioavailability, and decreased effect of age on bioavailability, of the medication in the container, when taken with food.Patent expiration dates:
- December 3, 2021✓
- December 3, 2021
- Skelaxin Consumer Information (Drugs.com)
- Skelaxin Consumer Information (Wolters Kluwer)
- Skelaxin Consumer Information (Cerner Multum)
- Skelaxin Advanced Consumer Information (Micromedex)
- Skelaxin AHFS DI Monographs (ASHP)
- Metaxalone Consumer Information (Wolters Kluwer)
- Metaxalone Consumer Information (Cerner Multum)
- Metaxalone Advanced Consumer Information (Micromedex)
- Metaxalone 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.|