Mesalamine is the generic ingredient in ten branded drugs marketed by Warner Chilcott Llc, Salix Pharms, Shire, Perrigo Israel, Teva, Meda Pharms, and Forest Labs Inc, and is included in eleven NDAs. There are thirteen patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
There are twenty drug master file entries for mesalamine. Fifteen 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|
Forest Labs Inc
|SUPPOSITORY;RECTAL||021252||Jan 5, 2001||DISCN||No||<disabled>||<disabled>|
|CAPSULE, EXTENDED RELEASE;ORAL||022301||Oct 31, 2008||RX||Yes||8,865,688||<disabled>||<disabled>|
Warner Chilcott Llc
|TABLET, DELAYED RELEASE;ORAL||021830||May 29, 2008||RX||Yes||6,893,662||<disabled>||Y||<disabled>|
|CAPSULE, EXTENDED RELEASE;ORAL||022301||Oct 31, 2008||RX||Yes||8,337,886||<disabled>||Y||<disabled>|
Warner Chilcott Llc
|CAPSULE, DELAYED RELEASE;ORAL||204412||Feb 1, 2013||RX||Yes||5,541,170||<disabled>||Y||<disabled>|
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