Biotech Values

[DewDiligence]

>MRX – The patent can still be effective even if it doesn't preclude the FDA from acting. Hatch-Waxman has no effect on patent rights.<

The issue is the automatic 30-month stay on FDA approval of a generic when a patent is listed in the Orange Book. In the case of Solodyn, the patent is not in the Orange Book because the drug is an antibiotic; hence, no 30-month stay, and nothing to prevent an at-risk generic launch.

As you point out, whether the patent itself stands up to challenge is a different matter.

When Genisi said, “…the Solodyn patent does not expire until 2018 but is useless and they know it” I think she meant that the patent is useless for averting an at-risk generic launch.