4 ms·
If the patent is invalidated, then what provides the generic company with exclusivity for two years-- I thought the regulatory exclusivity provided to first-in
by vibrio 7y ago
If the patent is invalidated, then what provides the generic company with exclusivity for two years-- I thought the regulatory exclusivity provided to first-in generics was only 6 months?
- refurb 7y agoIt was just an example. You are correct that the first generic entry gets just 6 months of exclusivity.
- jonlucc 7y agoI'm not at all an expert on generics, but the company suing to remove exclusivity has almost certainly done some groundwork needed to produce the generic drug. They likely need to figure out how to produce the drug as well as some business stuff like market determination, so a second generic manufacturer is probably a bit behind.
- vibrio 7y agofor significant small molecule drugs, there is commonly a cohort of generic firms ready at expiry. There is usually little barrier to entry beyond the patent or regulatory exclusivities. Prices are typically crushed after the 6 months. Biologics (antibodies/ vaccines) are a different story because of the complexity of their manufacturing and characterization.