GREY:ATBPF - Post by User
Comment by
Pragmatiston Dec 06, 2020 7:55pm
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Post# 32047095
RE:RE:RE:Great news
RE:RE:RE:Great newsMrMugsy wrote: I think Dan briefly talked to the patent and the 5 years - not that we can get an extra 5 years - but we can get 5 years regardless of the year we start selling. Does that sound correct?
ttps://camargopharma.com/resources/blog/alkermes-prodrug-for-treatment-of-multiple-sclerosis-nce/
Mugsy, I think your interpretation is correct. But is it five years, or three years? I guess it depends on what an "active moiety" is for OTEN. (and whether the quote in the referenced blog is accurate)
I think the CEO would know.
"The determination that the new drug is an NCE is critical because NCE status allows for 5 years of market exclusivity (also referred to as Hatch-Waxman exclusivity) after approval regardless of the patent situation. NCE exclusivity is granted for products “containing chemical entities never previously approved by FDA either alone or in combination”. This type of exclusivity protects against submission of applications (ANDA and 505(b)(2)) by a different manufacturer using the same prodrug (NCE) for a 5-year period, except for those containing a certification of patent invalidity or noninfringement, which allows for submission after 4 years. Exclusivity for 3-years (called “other” exclusivity) may be granted for a drug product that contains an active moiety that has been previously approved if new clinical investigations (other than bioavailability studies) have been conducted by the sponsor in support of approval."