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  #1  
Old 05-22-2012, 07:54 PM
Who knows Who knows is offline
cafepharma newbie
 
Join Date: Apr 2012
Posts: 8
Banghead Latuda Patent

WTF?! Is it true that Latuda loses patent protection in 2018 ? How the hell did that happen? How can the genius of DSP barely have 7 years of patent life, with only a schizo indication!! Hoping its the effects of alcohol, and I misread something. If true, by the time a BP indication comes around, they'll be planning the downsizing....
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  #2  
Old 05-22-2012, 09:05 PM
Anonymous
 
Posts: n/a
Default Re: Latuda Patent

Plus three years for each new indication. Welcome to pharma, Einstein. You get 20yrs from the time a drug is realized. Average time for a drug patent from it's approval is 7-10 yrs. So let's see... approval in 2010, launch in 2011, patent expiration in 2018. Sounds about right. Now let's extend that 3years for each new indication, a change in concentration, a new salt or esther of a drug product, a new drug delivery system (IM), plus 6 more mos for pediatric, and let's not forget countless patent exclusivity lawsuits.
I'd say I'm not going to worry about it for the time being. The sky is not falling, yet again, Chicken Little.
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  #3  
Old 05-23-2012, 05:54 PM
Anonymous
 
Posts: n/a
Default Re: Latuda Patent

6 more months for pediatric is true. 3 years for each new indication is absolutely absurd. You are sadly mistaken on that one my little friend. Blatently ignorant on your part.

I hope people don't listen to your advice when you give them stock tips.
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  #4  
Old 05-23-2012, 06:42 PM
Anonymous
 
Posts: n/a
Default Re: Latuda Patent

Quote:
Originally Posted by Anonymous View Post
6 more months for pediatric is true. 3 years for each new indication is absolutely absurd. You are sadly mistaken on that one my little friend. Blatently ignorant on your part.

I hope people don't listen to your advice when you give them stock tips.
When I first read this I thought what an idiot for clearly giving false info on patent extension for each new indication. I wasn't going to respond but saw your post and felt like making the idiot above who stated that feel more stupid.
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  #5  
Old 05-23-2012, 08:28 PM
Who knows Who knows is offline
cafepharma newbie
 
Join Date: Apr 2012
Posts: 8
Default Re: Latuda Patent

Chicken little, and 3 years for every new indication? You are a dumbass! I hope you're not that confident in front of your customers-- not helping company performance with your keen knowledge of the pharma industry....
Ask Lilly how many patent extensions they got when IM was approved, acute agitation, maintenance BPD, or adolescent schizo indication, for Zyprexa?
The answer, Einstein, is 6 mos for the adolescent schizo indication . That's it!
I'm sure the DSP CEO, Tada-san, was mistaken when he said "Latuda loses patent protection in 2018".... (read DSP financial report)
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  #6  
Old 05-23-2012, 09:16 PM
Anonymous
 
Posts: n/a
Default Re: Latuda Patent

"But market exclusivity can be gained separate from patent term extension. The FDA rules currently provide qualified drug products competition-free periods by preventing FDA or USDA approval of identical generic products. Market exclusivities enforced by either the FDA or the USDA include: (a) Five-year New Chemical Entity Exclusivity; (b) Three-year New Use/New Clinical Studies Exclusivity; (c) Seven-year Orphan Drug Exclusivity; (d) Six-month Pediatric Exclusivity; (e) 180-day and 30-month stays of FDA Approval; and (f) Animal Product Exclusivity."


See (b). This isn't from one website, it's from every site that talks about drug patents.
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  #7  
Old 05-23-2012, 09:21 PM
Anonymous
 
Posts: n/a
Default Re: Latuda Patent

Quote:
Originally Posted by Who knows View Post
Chicken little, and 3 years for every new indication? You are a dumbass! I hope you're not that confident in front of your customers-- not helping company performance with your keen knowledge of the pharma industry....
Ask Lilly how many patent extensions they got when IM was approved, acute agitation, maintenance BPD, or adolescent schizo indication, for Zyprexa?
The answer, Einstein, is 6 mos for the adolescent schizo indication . That's it!
I'm sure the DSP CEO, Tada-san, was mistaken when he said "Latuda loses patent protection in 2018".... (read DSP financial report)
And Tada-san is not mistaken when he says "Latuda loses patent protection in 2018"... It currently does. That will change. Duh...
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  #8  
Old 05-26-2012, 02:22 AM
Anonymous
 
Posts: n/a
Default Re: Latuda Patent

Quote:
Originally Posted by Anonymous View Post
"But market exclusivity can be gained separate from patent term extension. The FDA rules currently provide qualified drug products competition-free periods by preventing FDA or USDA approval of identical generic products. Market exclusivities enforced by either the FDA or the USDA include: (a) Five-year New Chemical Entity Exclusivity; (b) Three-year New Use/New Clinical Studies Exclusivity; (c) Seven-year Orphan Drug Exclusivity; (d) Six-month Pediatric Exclusivity; (e) 180-day and 30-month stays of FDA Approval; and (f) Animal Product Exclusivity."


See (b). This isn't from one website, it's from every site that talks about drug patents.
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...
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  #9  
Old 05-26-2012, 06:48 AM
Anonymous
 
Posts: n/a
Default Re: Latuda Patent

"Patent" WTF. It really does not matter. Lapoopa sales force will be cut long before this date.
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  #10  
Old 05-26-2012, 07:53 PM
Anonymous
 
Posts: n/a
Default Re: Latuda Patent

Quote:
Originally Posted by Anonymous View Post
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...
Why are you wasting your time trying to educate this moron? Not worth the energy you just spent typing your response.
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