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Forest/Biovail Tiazac "Late-Listed" Patent Could Delay Andrx Generic

Executive Summary

Forest may be able to forestall generic competition to Tiazac until mid-2003 as a result of a recently listed patent on the once-daily diltiazem product.

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Biovail Tiazac Manufacturing Change Prompts Discussions With FDA

Biovail is considering a manufacturing change for its hypertension drug Tiazac that would strengthen its claim that the product is covered under a recently-listed patent - but may trigger a decision by FDA that the patent cannot be used to block generic competition.

Biovail Tiazac Manufacturing Change Prompts Discussions With FDA

Biovail is considering a manufacturing change for its hypertension drug Tiazac that would strengthen its claim that the product is covered under a recently-listed patent - but may trigger a decision by FDA that the patent cannot be used to block generic competition.

Tiazac appeals court ruling

Miami federal court ruling in favor of Andrx upheld on appeal. The court ruled that Andrx' generic version of Biovail/Forest's Tiazac (diltiazem) does not infringe Biovail's patent No. 5,529,791. Biovail listed a patent (No. 6,162,463) in January, triggering new litigation (1"The Pink Sheet" Feb. 5, p. 27)

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