At this time, generic skelaxin metaxalone is available in one strength. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Mutual is also a pharmaceutical company that develops, manufactures. Skelaxin is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury. This was an antitrust action arising out of defendants unlawful exclusion of generic substitutes from the market for metaxalone, a prescription muscle relaxant marketed under the brand name skelaxin.
Doubling the dose of metaxalone tablets from 400 mg to 800 mg results in a roughly proportional increase in metaxalone exposure as indicated by peak plasma concentrations c max and area under the curve auc. You are in the class if you are an entity in the united states that purchased skelaxin directly from king pharmaceuticals, inc. Metaxalone, usp is a white to almost white, crystalline powder freely soluble in dichloromethane, soluble in methanol, sparingly soluble in ethanol and ethyl acetate, slightly soluble in toluene and isopropanol, insoluble in water and nhexane each tablet contains 800 mg metaxalone, usp and the following inactive ingredients. The division of bioequivalence has determined your metaxalone tablets, 800 mg, to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug rld, skelaxin tablets of king pharmaceuticals, inc. Apr 27, 2018 skelaxin metaxalone is available as an 800 mg oval, scored pink tablet chemically, metaxalone is 53,5 dimethylphenoxy methyl2oxazolidinone. Metaxalone is an oral drug that relaxes skeletal muscle the muscles that control movement of the body. Excluded from the class are the defendants, and their officers, directors, management, employees. Metaxalone is the generic name of the prescription drug skelaxin, which is used to relax tense muscles and relieve pain from muscle spasms. The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals.
The empirical formula is c 12 h 15 no 3, which corresponds to a molecular weight of 221. There is no unexpired exclusivity for this product in the orange book. Metaxalone is a skeletal muscle relaxant prescribed for the shortterm treatment of painful muscle spasms. It does not act directly on skeletal muscle, and the exact mechanism of action of metaxalone is unknown. Plaintiffs allege that defendant king pharmaceuticals, inc. It works by blocking nerve impulses or pain sensations in the brain.
Cases of serotonin syndrome, a potentially lifethreatening condition, have been reported during concomitant use of serotonergic drugs with skelaxin used within the recommended dosage range see precautions. Metaxalone c12h15no3 cid 15459 structure, chemical names, physical and chemical. Dec 02, 2019 thereafter, metaxalone concentrations decline loglinearly with a terminal halflife of 9. Codes beginning with b indicate bioequivalence has not been confirmed. The pharmacokinetics of metaxalone have been evaluated in healthy adult volunteers after single dose administration of skelaxin under fasted and fed conditions at doses ranging from 400 mg to 800 mg. Mutual and king then collaborated to obtain a patent for mutual s metaxalone metabolism data dpp compl. In re skelaxin metaxalone antitrust litigation, mdl no. Jun 07, 2019 if you are 65 or older, use metaxalone with care.
The orange book cumulative supplement showed the addition of periods of pc exclusivity i. Choosing a skeletal muscle relaxant american family physician. See what others have said about metaxalone, including the effectiveness, ease of use and side effects. Last minute dissolution testing requirement avoids forfeiture. Startup first 12 years requires a lot of effort but is no different. You will need to talk about the benefits and risks of using metaxalone while you are pregnant. We represented direct purchasers of the brand name drug skelaxin.
Nov 01, 2019 metaxalone, usp is a white to almost white, crystalline powder freely soluble in dichloromethane, soluble in methanol, sparingly soluble in ethanol and ethyl acetate, slightly soluble in toluene and isopropanol, insoluble in water and nhexane. Skelaxin may also be used for purposes not listed in this medication guide. Reclassify metaxalone tablets as a drug product with. All generic versions are considered equivalent to the brandname version. Absorption peak plasma concentrations of metaxalone occur approximately 3 hours after a 400 mg oral dose under fasted conditions.
Doubling the dose of metaxalone from 400 mg to 800 mg results in a roughly proportional increase in metaxalone exposure as indicated by peak plasma concentrations c max and area under the curve auc. Metaxalone skelaxin side effects, dosage, interactions. Metaxalone definition of metaxalone by medical dictionary. Methocarbamol and metaxalone are less sedating, although. Skelaxin metaxalone dosing, indications, interactions.
List of approved drug products containing metaxalone in the fda orange book on. Estimated cost to the pharmacist based on average wholesale prices rounded to the nearest dollar in red book. As a result of its multifaceted scheme and deal with mutual, king was able to keep generic versions of skelaxin the brand name for the muscle relaxant, metaxalone off the market. This category shows listings of farmers agencies for sale. Its exact mechanism of action is not known, but it may be due to general central nervous system depression. On january 29, 2004, mutual notified king that it had filed a paragraph iv. Skelaxin metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. This emedtv web page describes this medication in more detail, including information on how the muscle relaxant works, dosing tips, and potential side effects. Skelaxin direct anitrust litigation settlement class action. Metaxalone is used to help relax the muscles in your body and relieve the discomfort caused by acute shortterm, painful muscle or bone conditions. Find patient medical information for metaxalone oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
Metaxalone fda orange book approved drug product list. Thereafter, metaxalone concentrations decline loglinearly with a terminal halflife of 9. A categorized index of firstperson experiences with pharms metaxalone. The pto issued patent number 7,122,566 the 566 patent to mutual, which mutual then licensed to king and king listed in the orange book. The who orange book approved drug products with therapeutic. Metaxalone skelaxin is an inexpensive muscle relaxer.
Several commercial policies and a few life policies. Metaxalone is a prescription drug that is licensed for the treatment of muscle spasms. Metaxalone coupon save 75% with our coupons april 2020. Abundance of resources for those who seek out support. Orange book codes the orange book codes supply the fdas therapeutic equivalence rating for applicable multisource categories.
Skelaxin metaxalone is broken down by the liver, and eliminated from the body via the kidneys. Mar 12, 2019 skelaxin metaxalone is a muscle relaxant. As a result of its multifaceted scheme and deal with mutual, king was able to keep generic versions of skelaxin the brand name for the muscle relaxant metaxalone off the market until. Dizziness, drowsiness red or orange urine gi irritation and rare gi bleeding. Metaxalone may also be used for purposes not listed in this medication guide. However, this medicine does not take the place of rest, exercise, physical therapy, or other treatments that your doctor may recommend for your condition. It is used to treat pain and stiffness in muscles caused by strains, sprains, or other injury. Search helprx for free coupons to get up to 75% off the metaxalone generic price or search for skelaxin coupons and get up to 87% off. Class members eligible for skelaxin direct anitrust litigation settlement. The who orange book free ebook download as pdf file. Metaxalone relaxes muscles possibly by affecting the central nervous system brain and spinal cord and by causing sedation. Feb 26, 2019 skelaxin metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions.
Metaxalone is sold under the brand name of skelaxin. Skelaxin metaxalone warnings and precautions pfizer. Drugs az pill identifier supplements symptom checker diseases dictionary media. Tell your doctor if you are pregnant or plan on getting pregnant. Taking metaxalone with food can increase its absorption and enhance its effects such as sedation. Metaxalone fda prescribing information, side effects and. I have been working at northwestern mutual fulltime for more than a year. King subsequently listed the patent in the orange book dpp compl. Codes beginning with a signify the product is deemed therapeutically equivalent to the reference product for the category. Sun formerly owned by mutual pharmaceutical company, inc. Metaxalone marketed by king pharmaceuticals under the brand name skelaxin is a muscle relaxant used to relax muscles and relieve pain caused by strains, sprains, and other musculoskeletal conditions.
Metaxalone causes sedation and you should not drive, operate machinery, or perform other hazardous tasks while taking this medication. If either of those are not working at their best, you could have high levels of skelaxin metaxalone in your body and more side effects. Metaxalone is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury. Learn about side effects, drug interactions, dosages, warnings, and more. This section is sponsored by capital resources llc, the premier agency lender. Antitrust lawsuit national antitrust lawsuits and lawyers. Drug interactions and with skelaxin as a single agent taken at doses higher than the recommended dose see overdosage. Generic metaxalone is covered by some medicare and insurance plans, but manufacturer and pharmacy. Metaxalone fda prescribing information, side effects and uses. The publication approved drug products with therapeutic equivalence evaluations commonly known as the orange book identifies drug products approved on the basis of safety and. Metaxalone belongs to a group of medications called.
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