At the time this process was initiated, neither orphan drug status or even the more limited Hatch Waxman period of exclusivity was guaranteed.

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In a course he teaches at Boston University, Astrue teaches students six ways of getting a drug approved when another treatment has received orphan drug status.

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Orphan-drug status, for example, can help a biotech firm raise capital on the strength of its latest product.

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Because BioMarin's drugs serve small patient populations, each drug is granted orphan status upon approval, which means exclusivity for seven years in the U.S. Revenues from one drug should eventually throw off enough cash to fund further drug development, figures Yun.

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But Tercica has orphan status for its drug, which should protect Increlex from competition for seven years.

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More recently, Serono (nyse: SRA - news - people ), a Swiss biotech, was able to get its drug, Rebif, onto the U.S. market despite Avonex's orphan status.

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