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<p>[QUOTE="Anonymous, post: 4380804"]WRONG, WRONG, WRONG</p><p><br /></p><p>Section (b) or "the 3-year exclusivity" provision only provides protection for the new indications (bipolar, depression with mixed features, etc), it DOES NOT prevent a generic from launching under the original (schizophrenia) indication in 2018 when the patent expires. A generic version can still be approved using the old labeling – i.e., by carving out the exclusive labeling language – before the three year exclusivity of the next indication terminates. Given the liberal generic substitution rules in most states, this 3-year exclusivity for new indications is often considered to be of limited value. Not to mention, there is no reliable way to extend the patent beyond 2018, only exclusivity can be extended by 3 years for each indication, not the patent.</p><p><br /></p><p>Teva and numerous other big player generic companies have been quite successful at launching their generic drugs under the original indication at time of patent expiry because there is no infringement and exclusivity for the first (original) indication dies at the five year mark. Like it or not, Latuda will be generic for schizophrenia in 2018 and off-label use of those generics will eat into bipolar indication profits regardless of exclusivity obtained for that indication- that is the sad truth and destiny for all NCE's.</p><p><br /></p><p>T minus 5.5 years and counting until generic Latuda launch…tick tock...tick tock...[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 4380804"]WRONG, WRONG, WRONG Section (b) or "the 3-year exclusivity" provision only provides protection for the new indications (bipolar, depression with mixed features, etc), it DOES NOT prevent a generic from launching under the original (schizophrenia) indication in 2018 when the patent expires. A generic version can still be approved using the old labeling – i.e., by carving out the exclusive labeling language – before the three year exclusivity of the next indication terminates. Given the liberal generic substitution rules in most states, this 3-year exclusivity for new indications is often considered to be of limited value. Not to mention, there is no reliable way to extend the patent beyond 2018, only exclusivity can be extended by 3 years for each indication, not the patent. Teva and numerous other big player generic companies have been quite successful at launching their generic drugs under the original indication at time of patent expiry because there is no infringement and exclusivity for the first (original) indication dies at the five year mark. Like it or not, Latuda will be generic for schizophrenia in 2018 and off-label use of those generics will eat into bipolar indication profits regardless of exclusivity obtained for that indication- that is the sad truth and destiny for all NCE's. T minus 5.5 years and counting until generic Latuda launch…tick tock...tick tock...[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
Sunovion
>
Latuda Patent
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
Sunovion
>
Latuda Patent
>