Replies to post #402459 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

No!!!

The exclusivity applies only to the sale of the approved drug ( in your case trofenitide)

See below

How long does an exclusivity period last?
It depends on what type of exclusivity is at issue.

Orphan Drug Exclusivity (ODE) – 7 years
New Chemical Entity Exclusivity (NCE) – 5 years
Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities
New Clinical Investigation Exclusivity – 3 years
Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity
Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only)
Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)
See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, 505(j)(5)(B)(iv), and Section 505(j)(5)(B)(v) of the FD&C Act.

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

Trofinetide's exclusivity has nothing to due with Anavex's blarcamesine.

GOD bless,

[Doc328]

Orphan drugs get 7 years of exclusivity and typical new drugs get only 5 years. Exclusivity does not prevent marketing of a new chemical entity for the orphan disease but rather a generic with the same active moiety. So the FDA's action on trofinetide has no bearing on the regulatory approval of blarcamesine. Though regulatory exclusivity is 7 years for Rett (and other orphan diseases), for AD or PDD, it would only be 5 years. However, patents listed in the Orange book associated with the approval of a drug can extend the commercial exclusivity (commercial exclusivity is the longer of regulatory and legal exclusivity). Patents not listed in the Orange book can usually be litigated away so seldom prolong the exclusivity.