Teva will be eligible for 180 days of marketing exclusivity as the first company to file with the FDA for generic Combivir tablets.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained US Food and Drug Administration (FDA) approval for its generic version of Combivir tablets, an HIV treatment made by ViiV Healthcare Company. Teva plans to begin deliveries in the fourth quarter, under the terms of an agreement with ViiV and GlaxoSmithKline plc (NYSE; LSE: GSK)
According to IMS, Combivir has $315 million in annual sales in the US.
Since Teva is the first company to file an Abbreviated New Drug Application (ANDA) with the FDA for generic Combivir tablets, Teva will be eligible for 180 days of marketing exclusivity.
Teva's share price rose 1.9% on Nasdaq on Friday to $50.50, giving a market cap of $47.45 billion and rose 2.5% in morning trading on the TASE today to NIS 174.80.
Published by Globes [online], Israel business news - www.globes-online.com - on May 29, 2011
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