6 ms·
It's... complicated but I assume the GP meant new drug product exclusivity [1] which is a process by which a pharmaceutical manufacturer can get a short window
by akiselev 4y ago
It's... complicated but I assume the GP meant new drug product exclusivity [1] which is a process by which a pharmaceutical manufacturer can get a short window of exclusivity for a new approved use without rights over the original patent. That exclusivity is largely for generic manufacturers [2] though and it's separate from the patent patent term restoration [3] the FDA grants to patent holders to help with the time it takes to get to market.
"Re-patent" would mean something different like Shire patenting Vyvanse by adding an amino acid cap to amphetamines, changing it enough that it becomes a new drug with a new patent. That would require clinical trials and all the expense that goes with them.
[1] https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-new-drug-product-exclusivity https://www.fda.gov/drugs/cder-small-business-industry-assis...
[2] https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity https://www.fda.gov/drugs/development-approval-process-drugs...
[3] https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-frequently-asked-questions-patent-term-restoration-program https://www.fda.gov/drugs/cder-small-business-industry-assis...
- tptacek 4y agoModifying HCQ to HCQ' would also do nothing to establish exclusivity over HCQ. It's a weird argument.
- akiselev 4y agoI think the OP just made a fly-by comment using very imprecise language. Most people assume drug exclusivity works through patents without giving generics with expired patents (like HCQ) much thought. They wouldn't need to modify it for exclusivity via Abbreviated New Drug Application - I just don't see the FDA accepting any evidence short of a phase III clinical trial that HCQ helps with Alzheimers to fulfill the new use requirements. At best they'd be able to run a proper clinical trial for some cocktail of generic drugs and use ANDAs to prevent competitors from using those generics in their own cocktail for a few years.
- DanBC 4y agoIt would if you sued to prevent the off-label use, which is something that happened with avastin and lucentis for wet AMD.
- doubleg72 4y agoLove when people take the time to know what they are talking about.. Vyvanse is a perfect example, they took a drug and made a prodrug.