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Metaxaloneis the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Amneal Pharms, Appco, Lannett Co Inc, Mountain, Primus Pharms, Sandoz, Sciegen Pharms Inc, and King Pharms, and is included in nine 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 suppliers are listed for this compound.
Summary for metaxalone
|Drug Master File Entries:||20|
|Suppliers / Packagers:||30|
|Bulk Api Vendors:||94|
|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|
|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|
|Mountain||METAXALONE||metaxalone||TABLET;ORAL||040486-001||Feb 27, 2015||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Sandoz||METAXALONE||metaxalone||TABLET;ORAL||040445-001||Mar 31, 2010||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|King Pharms||SKELAXIN||metaxalone||TABLET;ORAL||013217-001||Approved Prior to Jan 1, 1982||DISCN||Yes||No||Start Trial||Start Trial||Start Trial|
|Amneal Pharms||METAXALONE||metaxalone||TABLET;ORAL||203399-001||Jun 21, 2013||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Appco||METAXALONE||metaxalone||TABLET;ORAL||208774-001||Sep 24, 2018||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|King Pharms||SKELAXIN||metaxalone||TABLET;ORAL||013217-003||Aug 30, 2002||AB||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|Sciegen Pharms Inc||METAXALONE||metaxalone||TABLET;ORAL||207466-002||Mar 13, 2020||AB||RX||No||No||Start Trial||Start Trial||Start 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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