Cevimeline hydrochloride is the generic ingredient in three branded drugs marketed by Apotex Inc, Pack Pharms Llc, Roxane, and Daiichi Sankyo, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
There are four drug master file entries for cevimeline hydrochloride. Three suppliers are listed for this compound.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|CAPSULE;ORAL||091260||Aug 25, 2011||RX||No||<disabled>||<disabled>|
|CAPSULE;ORAL||020989||Jan 11, 2000||RX||Yes||5,340,821||<disabled>||<disabled>|
|CAPSULE;ORAL||091591||Jul 8, 2013||RX||No||<disabled>||<disabled>|
Pack Pharms Llc
|CAPSULE;ORAL||203775||Jun 4, 2014||RX||No||<disabled>||<disabled>|
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