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Metaxaloneis the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Amneal Pharms, Ingenus Pharms Llc, Lannett Co Inc, Mountain, Primus Pharms, Rising, Sandoz, Sciegen Pharms Inc, and King Pharms, and is included in ten NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Metaxalone has two patent family members in two countries.
There are twenty drug master file entries for metaxalone. Thirty-two suppliers are listed for this compound.
Summary for metaxalone
|Drug Master File Entries:||20|
|Finished Product Suppliers / Packagers:||32|
|Raw Ingredient (Bulk) Api Vendors:||104|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for metaxalone|
|Drug Sales Revenues:||Drug sales revenues for metaxalone|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for metaxalone|
|What excipients (inactive ingredients) are in metaxalone?||metaxalone excipients list|
|DailyMed Link:||metaxalone at DailyMed|
Recent Clinical Trials for metaxalone
Identify potential brand extensions & 505(b)(2) entrants
|Rothman Institute Orthopaedics||N/A|
|Montefiore Medical Center||Phase 4|
Pharmacology for metaxalone
|Physiological Effect||Centrally-mediated Muscle Relaxation |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|King Pharms||SKELAXIN||metaxalone||TABLET;ORAL||013217-003||Aug 30, 2002||AB||RX||Yes||Yes||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Actavis Labs Fl Inc||METAXALONE||metaxalone||TABLET;ORAL||203695-001||Jun 15, 2017||AB||RX||No||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Lannett Co Inc||METAXALONE||metaxalone||TABLET;ORAL||204770-001||Nov 22, 2016||AB||RX||No||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Sandoz||METAXALONE||metaxalone||TABLET;ORAL||040445-001||Mar 31, 2010||AB||RX||No||No||⤷ Free Forever Trial||⤷ Free Forever Trial||⤷ Free Forever Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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