Anavex Life Sciences Corp (AVXL)

[blu_1]

One of the patent expert dudes on ymb said even with no patent for the drug we still get 5 years of exclusivity protection for the drug for some reason. I believe there is 7 yrs of market exclusivity for the use of drug for a specific orphan disease, but that wouldn't provide exclusivity for other diseases.

eggahmuffin on ymb posted the followiwng last week: "As I understand it, based on the following fda info, Anavex would get 5 years exclusivity for 2-73 even if it's patents had expired. Am I misunderstanding this? Comments?

wwwDOTfdaDOTgov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm

"A 5-year period of exclusivity is granted to new drug applications for products containing chemical entities never previously approved by FDA either alone or in combination. No 505(b)(2) application or ANDA may be submitted during the 5-year exclusivity period except that such applications may be submitted after 4 years if they contain a certification of patent invalidity or noninfringement. A 3-year period of exclusivity is granted for a drug product that contains an active moiety that has been previously approved, when the application contains reports of new clinical investigations (other than bioavailability studies) conducted or sponsored by the sponsor that were essential to approval of the application. For example, the changes in an approved drug product that affect its active ingredient(s), strength, dosage form, route of administration or conditions of use may be granted exclusivity if clinical investigations were essential to approval of the application containing those changes."