Wyeth OTC loratadine “approvable”
This article was originally published in The Tan Sheet
Executive Summary
FDA deems firm's application for Alavert, an OTC version of Schering-Plough's Claritin Reditabs (loratadine), approvable July 3. Alavert will employ CIMA Labs' DuraSolv technology; CIMA announced an exclusive license, supply agreement with Wyeth June 27 ("1The Tan Sheet" July 1, 2002, p. 4). Wyeth filed an NDA under section 505(b)(2) in January; McNeil also filed a 505(b)(2) application in November. Schering sued both companies for patent infringement 2("The Tan Sheet" Feb. 4, 2002, p. 3)...
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CIMA Labs
Royalties and manufacturing revenues from Wyeth's Alavert expected to be major contributor to sales growth for fast-dissolve technology firm in 2003. Loratadine product "should end up this year [contributing] about 10% of our total revenues," President & CEO John Seibert, PhD, said during Feb. 20 analysts call. He noted Wyeth is "looking at this as the largest OTC product introduction in their history, and these are the people that brought you Advil." CIMA signed an exclusive supply agreement with Wyeth last June; Alavert employs CIMA's DuraSolv technology (1"The Tan Sheet" July 22, 2002, In Brief). Seibert estimated OTCs using CIMA technology account for 25% to 30% of the firm's revenues. CIMA's Q4 sales grew 68.5% to $15.5 mil., while annual sales rose 45.6% to $46.6 mil...
Wyeth OTC Loratadine Launch Unaffected By ANDA Exclusivity Issues – Exec
Wyeth Consumer Healthcare, which reported sluggish third quarter sales, could experience a big revenue boost late in Q4 if its plans to launch OTC loratadine upon expiration of Schering-Plough's patent remain on track
McNeil loratadine
J&J division will market OTC equivalent to Schering-Plough's Claritin under the brand name Proclir. On July 19, FDA deemed McNeil's NDA (021339) for loratadine tablets "approvable." Wyeth's NDA (021375) for Alavert, the equivalent to Claritin Reditabs, was pronounced "approvable" on July 3 (1"The Tan Sheet" July 22, 2002, In Brief). Schering filed patent infringement lawsuits against McNeil in December, Wyeth in January...