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Wyeth Loratadine Exclusivity Should Reflect Alavert Approval Date – Andrx

This article was originally published in The Tan Sheet

Executive Summary

Marketing exclusivity for Wyeth Consumer Healthcare's generic loratadine tablets should begin on "the date on which Wyeth began marketing generic loratadine in its product Alavert," rival marketer Andrx asserts in a Feb. 27 citizen petition

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Loratadine exclusivity

Andrx "will accept Wyeth's offer to forsake generic exclusivity" after Aug. 9 and requests FDA adopt "appropriate measures to implement Wyeth's offer" in March 21 comments. In a recent citizen petition, Andrx alleged marketing exclusivity for Wyeth's generic loratadine should start from the Alavert approval date, although Wyeth disputed the assertion (1"The Tan Sheet" March 31, 2003, p. 9). While Andrx accepts Wyeth's "compromise," firm maintains Wyeth's position "cannot be right," because firm "implicitly concedes as much by offering to forsake generic exclusivity 180 days after a date that is before the date on which it will commence" marketing of generic loratadine...

Loratadine exclusivity

Andrx "will accept Wyeth's offer to forsake generic exclusivity" after Aug. 9 and requests FDA adopt "appropriate measures to implement Wyeth's offer" in March 21 comments. In a recent citizen petition, Andrx alleged marketing exclusivity for Wyeth's generic loratadine should start from the Alavert approval date, although Wyeth disputed the assertion (1"The Tan Sheet" March 31, 2003, p. 9). While Andrx accepts Wyeth's "compromise," firm maintains Wyeth's position "cannot be right," because firm "implicitly concedes as much by offering to forsake generic exclusivity 180 days after a date that is before the date on which it will commence" marketing of generic loratadine...

Loratadine exclusivity

Andrx "will accept Wyeth's offer to forsake generic exclusivity" after Aug. 9 and requests FDA adopt "appropriate measures to implement Wyeth's offer" in March 21 comments. In a recent citizen petition, Andrx alleged marketing exclusivity for Wyeth's generic loratadine should start from the Alavert approval date, although Wyeth disputed the assertion (1"The Tan Sheet" March 31, 2003, p. 9). While Andrx accepts Wyeth's "compromise," firm maintains Wyeth's position "cannot be right," because firm "implicitly concedes as much by offering to forsake generic exclusivity 180 days after a date that is before the date on which it will commence" marketing of generic loratadine...

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