Replies to post #337992 on Anavex Life Sciences Corp (AVXL)

[WolfofMia]

Google patent vs exclusivity.

or just look here:

https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity

[Investor2014]

The answer is maybe.

Refer to this: https://www.fda.gov/files/drugs/published/Exclusivity-and-Generic-Drugs--What-Does-It-Mean-.pdf

A brand-name drug with an active ingredient that has been approved before may be awarded a three-year exclusivity in certain circumstances, such as if a new way of delivering the active ingredient is proposed (for example, a tablet rather than a liquid) or a different disease or condition the drug can treat is identified. To get this approval, the drug company must conduct new clinical studies in humans.

Note that patent rights and FDA granted exlusivity runs in parallel.

[tredenwater2]

Question for the board: at some point Anavex will lose patent rights for A273. Generics will hit the market when the FDA allows competition. Assuming the clock for Rett begins ticking in 2022 or 2023, would each subsequent NDA for A273 extend the protection, or doesn’t it matter once the drug is approved the first time?

Since Dr. Missling used Alexion as an example of what can be achieved in the rare disease market as a model perhaps their model may give answers to questions about patent exclusivity. On another note where is all the “backlog” of Orphan Drug Designations the FDA was working on cleaning up? That was over 2 years ago, should be some headway in regards to this and I would expect one or two more ODD to come to Anavex for new diseases.

I am also sure, as Dr Missling is meticulous in his methodology, that there is a plan in the “rollout” of rare diseases in the furthering of protection of patent rights.