Anavex Life Sciences Corp (AVXL)

[sokol]

The FDA only acts in a ministerial capacity. It does not decide whether a patent is valid and enforceable. Courts do that. You surmise correctly about the possibility of blocking of generics. Big pharma has used Orange Book listing of "patents" to block generic competition. Big pharma has been sued for violating antitrust laws for wrongfully listing patents in the Orange Book.

See this as one example: Wrongful "Orange Book" Listing Raises Red Flag with FTC; Leads to Consent Order with Biovail Corp. Concerning its Drug Tiazac

https://www.ftc.gov/news-events/press-releases/2002/04/wrongful-orange-book-listing-raises-red-flag-ftc-leads-consent

There are other cases where companies were sued for wrongful Orange Book listings to block generics. Another examplw, BMS was sued regarding blocking generic competition for Buspar.