Anavex Life Sciences Corp (AVXL)

[Investor2014]

Anavex Plus patent

Fixed-dose combination drugs (FDCs) are formulations that contain two or more active ingredients in a single dose [11]. According to the FDA, “two or more drugs may be combined in a single dose when each component makes a contribution to the claimed effects, and the dosage of each component (i.e., amount, frequency, and duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy”

In the US, if a FDC is novel, non-obvious, and useful, it can be patented and the exclusion of competitors from the market can be enforced (Fig 2). In this case, the sponsor company is able to add patent and exclusivity time to the combination of individual products included in the FDC, for which patents and exclusivities may be expired or close to expire.

In other words Anavex will need to manufacture the FDC (Anavex Plus) as per the non-obvious dose combination.

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0140708