Jump to content


Click here to find a mentally interesting date at No Longer Lonely Keep Crazymeds on the air. Donate some spare electronic currency you have floating around The Cloud



Some Crazymeds mugs to help you wash down your meds. Get mugged for at Straitjacket T-shirts for more. 11oz mugs are $13. 15oz mugs are $14.
Mentally Interesting mug
Mentally Interesting
Medicated For Your Protection mug
Medicated For Your Protection
Team Bipolar mug
Team Bipolar
Brain Cooties Aren
Brain Cooties Aren't Contagious

Generic Risperdal


  • Please log in to reply
12 replies to this topic

#1 In_Remission_backtobasicsyo

In_Remission_backtobasicsyo
  • Guests

Posted 08 January 2008 - 12:28 AM

OK--question: I konw risperdal is going generic. Just...when? I've read conflicting acounts, it's either December 2007 OR june 2008.

Anyone know which is accurate? Like to know as I just got it scripted.

Thanks!



Enable Crazymeds to keep ranting about being crazy and taking meds. Donate some spare electronic currency you have floating around The Cloud


Stick to your treatment plan with buttons and magnets. 2.25″ $4 & 3.5″ $4.50 at Straitjacket T-shirts Some designs available in packs of 10 and 100
Pile of Pills buttons at Straitjacket T-shirts
Pile of Pills
Vaccines
Vaccines Cause Immunity
Medicated For Your Protection magnets at Straitjacket T-shirts
Medicated For Your Protection
Mentally Interesting buttons at Straitjacket T-shirts
Mentally Interesting

#2 dymphna

dymphna

    Ready for the MCAT

  • Citizen Medical Expert
  • PipPipPipPip
  • 4,457 posts
  • Diagnoses:Suck-Ass Epilepsy, Perma-Migraine, Endocrine Hell, Associated Mood Crap
  • Current Meds:LTG 600, TPA 500, CLZ 1.5-2, Dostinex 0.5, Zoloft 0.25-.5
  • Location:A Mac Computer

Posted 08 January 2008 - 04:53 AM

OK--question: I konw risperdal is going generic. Just...when? I've read conflicting acounts, it's either December 2007 OR june 2008.

Anyone know which is accurate? Like to know as I just got it scripted.

Thanks!


Actually, no time soon.

Although the original patent for Risperdal for mania for adults expired in Dec 2007, Janssen Pharmaceuticals applied for and received additional applications ('exclusivities') for the drug that don't start to expire until Oct 2009 and finish Aug 2010. Then, someone has to get a generic version together, through the FDA process, and to market.

Sorry.


Dymphna
  • 0

Yes, my name really is Dymphna.

 

I'm not a doctor, nurse, pharmacist, or therapist.

I can find you an answer and I won't blow smoke up your ass.

 

St. Dymphna is the Patron for brain maladies.

 

I'm the Enforcer.

 

eqnmrt.jpg

 


#3 Silver

Silver

    Would-be Neurologist

  • Members
  • PipPipPip
  • 905 posts

Posted 08 January 2008 - 10:40 AM

OK--question: I konw risperdal is going generic. Just...when? I've read conflicting acounts, it's either December 2007 OR june 2008.

Anyone know which is accurate? Like to know as I just got it scripted.

Thanks!


Actually, no time soon.

Although the original patent for Risperdal for mania for adults expired in Dec 2007, Janssen Pharmaceuticals applied for and received additional applications ('exclusivities') for the drug that don't start to expire until Oct 2009 and finish Aug 2010. Then, someone has to get a generic version together, through the FDA process, and to market.

Sorry.


Dymphna

Dymphna - I'm going nuts trying to find a cite for this. Yes, I see all the Orange Book dates. But I still see 6/29/08 as the first possible generic date, and it's still the date that shows up in my epocrates / Stockleys (and in my insurance plan). I remember it was 12/29/07 and the peds pushed it out 6 months...

I believe you, but can you toss up a cite so I can stop digging around for it?

Thanks-
Silver

Edited by Silver, 08 January 2008 - 10:41 AM.

  • 0
Bipolar I

Science is not about building a body of known 'facts'. It is a method for asking awkward questions and subjecting them to a reality-check, thus avoiding the human tendency to believe whatever makes us feel good. --Terry Pratchett

#4 dymphna

dymphna

    Ready for the MCAT

  • Citizen Medical Expert
  • PipPipPipPip
  • 4,457 posts
  • Diagnoses:Suck-Ass Epilepsy, Perma-Migraine, Endocrine Hell, Associated Mood Crap
  • Current Meds:LTG 600, TPA 500, CLZ 1.5-2, Dostinex 0.5, Zoloft 0.25-.5
  • Location:A Mac Computer

Posted 08 January 2008 - 01:05 PM

OK--question: I konw risperdal is going generic. Just...when? I've read conflicting acounts, it's either December 2007 OR june 2008.

Anyone know which is accurate? Like to know as I just got it scripted.

Thanks!


Actually, no time soon.

Although the original patent for Risperdal for mania for adults expired in Dec 2007, Janssen Pharmaceuticals applied for and received additional applications ('exclusivities') for the drug that don't start to expire until Oct 2009 and finish Aug 2010. Then, someone has to get a generic version together, through the FDA process, and to market.

Sorry.


Dymphna

Dymphna - I'm going nuts trying to find a cite for this. Yes, I see all the Orange Book dates. But I still see 6/29/08 as the first possible generic date, and it's still the date that shows up in my epocrates / Stockleys (and in my insurance plan). I remember it was 12/29/07 and the peds pushed it out 6 months...

I believe you, but can you toss up a cite so I can stop digging around for it?

Thanks-
Silver


021444 001 4804663 DEC 29,2007 Y Y U-516
021444 001 4804663*PED JUN 29,2008
021444 001 5648093 JUL 15,2014 Y
021444 001 5648093*PED JAN 15,2015
021444 001 6224905 JUN 10,2017 Y
021444 001 6244905*PED DEC 10,2017

For anyone reading this, the "Orange Book" is the FDAs bible of approved drugs. You type in the chemical or brand name of a drug and hit the appropriate button and information pops up on all the available forms of that drug. If you put in the chemical name, any available generics will pop up. If you put in the trade name, only the brand will pop up. Clicking on the links within the drug for "patent and exclusivity" info will give you a tabular version of what I've put above (that one is for Risperdal). Each date corresponds to a dose/form of the drug that is under patent and/or exclusivity protection.


From the FAQ:

What is the difference between patents and exclusivity?

Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met. See 21 C.F.R. 314.108. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.

2.How long is a patent granted for?

Patents expire 20 years from the date of filing. Many other factors can affect the duration of a patent.

3.How long is exclusivity granted for?

It depends on what type of exclusivity is granted.
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge (PC) 180 days (this exclusivity is for ANDAs only)

See 21 C.F.R. 314.108 New Drug Product Exclusivity.

4. Why does the exclusivity expire before the patent?
Patent before exclusivity?
Why does a particular drug product only have patents?
Only have exclusivity?
Have neither?

Patents can be expired before drug approval, issued after drug approval, and anywhere in between. Exclusivity is granted upon approval of a drug product if the statutory requirements are met. Some drugs have both patent and exclusivity protection while others have just one or none. Patents and exclusivity may or may not run concurrently and may or may not encompass the same claims. Exclusivity is not added to the patent life. Expired patents and exclusivity are not included in the published list.

6. What are the PED designations on patents and exclusivity as listed in the Orange Book?

When pediatric exclusivity is granted to a drug product, a period of 6 months exclusivity is added to all existing patents and exclusivity on all applications held by the sponsor for that active moiety. Pediatric exclusivity does not stand alone. PED is annotated in the exclusivity column and is linked to exclusivity formerly granted. In the patent column, the patent is shown twice-once with the original patent expiration date and a second time reflecting the six month period of EXCLUSIVITY that links to that particular patent.

Source: http://www.fda.gov/cder/ob/faqs.htm


As to the dates I put in my original post, I found them here, listed under application number 021444 for .5 - 4mg Risperdal. I did make an error though on end dates: there is a PEDS date for Feb, 2011 (and there are even later dates from the table above). It appears that the company is simply "hop-scotching" exclusivities to maintain patent protection.


Dymphna
  • 0

Yes, my name really is Dymphna.

 

I'm not a doctor, nurse, pharmacist, or therapist.

I can find you an answer and I won't blow smoke up your ass.

 

St. Dymphna is the Patron for brain maladies.

 

I'm the Enforcer.

 

eqnmrt.jpg

 


#5 Jerod Poore

Jerod Poore

    Administrator

  • Chief Citizen Medical Expert
  • PipPipPipPip
  • 4,063 posts
  • Diagnoses:Bipolar NOS, Epilepsy NOS, Autism, Agoraphobia/Social Anxiety
  • Current Meds:LTG 200mg, TPM 250mg, protriptyline 30mg, MPH 5-10mg, buspirone 45mg EPA 600
  • Location:Saint Regis Montana

Posted 08 January 2008 - 03:09 PM

Then, someone has to get a generic version together, through the FDA process, and to market.


This is the other key part of the process that keeps many drugs brand name after their patents expire.

Just because they can go generic at a certain date doesn't mean that they will do so any time soon after that date.

The FDA can hold it up because the pioneering company, or the US company who has the license to the brand from the overseas company who pioneered the drug, could bitch about it to an FDA commissioner whom they own who thinks the company who applied to manufacture the generic equivalent may not be up to snuff. That holds things up.

And there is that bit about the exclusivities. So what if Teva finally gets to make generic risperidone? It can be prescribed only for schizophrenia. Maybe adult bipolar mania by the time the process is done, but that requires yet another FDA application and yet another fight with Janssen. The market for Risperdal these days is pediatric bipolar and autism, and that's six to nine years before there's any real money to be made for risperidone after ramping up all the new production.

Accountants make a lot of decisions as to when a generics manufacturer is going to bother with trying for an application to make the drug, not doctors.

Now Janssen might just make a good strategic move and make their own generic risperidone for schizophrenia and adult bipolar mania, but I wouldn't bet any folding money on that. Just because it would be both profitable and compassionate and all. Hell, even if Johnson and Johnson had to spin off a new company to make generic risperidone and generic topiramate when the time came they'd be one up on all of the generic manufacturers.

But what do I know? I'm just a crazy tard.
  • 0
Jerod Poore - Owner, Founder and Chief Citizen Medical Expert of crazymeds.us
Keep up with Crazymeds and my slow descent into irreparable madness boring life via your preferred social media:

Wear my Straitjacket     Batshit Crazy Blog

I am not a doctor, nor do I play one on TV. No doctor, nurse, pharmacist or lawyer was harmed in the creation of this post. No warranty is expressed or implied. Not valid with any other offer. Void where prohibited.

Current meds: lamotrigine 300mg, topiramate 325mg, buspirone 60mg, protriptyline 60mg, EPA 600mg, methylphenidate 5-10mg, lorazepam 1mg PRN
Past meds (likely incomplete): Abilify, clonazepam, desipramine, diazepam, Gabitril, lithium, Neurontin, Paxil, prochlorperazine, Provigil, Prozac, Risperdal, Seroquel, Serzone, Strattera, Trileptal, Zyprexa

#6 Silver

Silver

    Would-be Neurologist

  • Members
  • PipPipPip
  • 905 posts

Posted 08 January 2008 - 06:14 PM

021444 001 4804663 DEC 29,2007 Y Y U-516
021444 001 4804663*PED JUN 29,2008
021444 001 5648093 JUL 15,2014 Y
021444 001 5648093*PED JAN 15,2015
021444 001 6224905 JUN 10,2017 Y
021444 001 6244905*PED DEC 10,2017
...
As to the dates I put in my original post, I found them here, listed under application number 021444 for .5 - 4mg Risperdal. I did make an error though on end dates: there is a PEDS date for Feb, 2011 (and there are even later dates from the table above). It appears that the company is simply "hop-scotching" exclusivities to maintain patent protection.

FWIW, the 021444 is the meltaway tablet. 020272 is the regular tablet, which should come open first for generics.
So, per that, and per the appendix to the Orange Book, yes, you are right - Feb 2011 is the latest date listed for regular tablets. Later for the M-tabs and the Consta forms.

However. The only date for Risperdal/oral I can find on anything, including J&J's own press releases and SEC filings, is June 2008.
Stockley's updates hourly. And it's telling me 6/08. Too late to call them. Insurers are saying the same thing.
It's entirely possible that all these sources have it wrong, but most of them are fairly recent. Stockley's is showing me an interaction that showed up in a journal today.

Stupid question: are perhaps all exclusivities not created equal? Is there such a thing as an exclusivity that allows one the "on-label" designation for the 8 (or whatever) other conditions, but then still allows the generic manufacturers to make and sell the drug for one specific indication?
  • 0
Bipolar I

Science is not about building a body of known 'facts'. It is a method for asking awkward questions and subjecting them to a reality-check, thus avoiding the human tendency to believe whatever makes us feel good. --Terry Pratchett

#7 In_Remission_backtobasicsyo

In_Remission_backtobasicsyo
  • Guests

Posted 09 January 2008 - 01:15 AM

MMMkay, being's I'm no fool when it comes to marketing, I'm well aware that it takes time for patent end/new company to make generic-->new generic on market.

However. The plug HAS been pulled on Risperdal samples, this is quite apparent. I just got the last, I believe, that my little town had to offer. And yes, my pdoc had quite the time cadging even one box! (mmm minty meltaways!)

That alone, if anything, leads me to think that something's gonna come down the pipe...

#8 Silver

Silver

    Would-be Neurologist

  • Members
  • PipPipPip
  • 905 posts

Posted 09 January 2008 - 09:47 AM

Well, part of that might be that they are pushing Invega, and it's awkward to push Invega while badmouthing your own other product you're handing out. They're still sampling Consta around here, though.

Still. I have multiple reliable sources telling me 6/08 and the gummint - which should be the last word - telling me ?maybe something different.

I'll try to call the J&J/Janssen rep today. Maybe he knows.
  • 0
Bipolar I

Science is not about building a body of known 'facts'. It is a method for asking awkward questions and subjecting them to a reality-check, thus avoiding the human tendency to believe whatever makes us feel good. --Terry Pratchett

#9 dymphna

dymphna

    Ready for the MCAT

  • Citizen Medical Expert
  • PipPipPipPip
  • 4,457 posts
  • Diagnoses:Suck-Ass Epilepsy, Perma-Migraine, Endocrine Hell, Associated Mood Crap
  • Current Meds:LTG 600, TPA 500, CLZ 1.5-2, Dostinex 0.5, Zoloft 0.25-.5
  • Location:A Mac Computer

Posted 09 January 2008 - 11:17 AM

We could start a revolution: A bunch of crazy people all calling drug reps and asking for dates on generic availability.


d
  • 0

Yes, my name really is Dymphna.

 

I'm not a doctor, nurse, pharmacist, or therapist.

I can find you an answer and I won't blow smoke up your ass.

 

St. Dymphna is the Patron for brain maladies.

 

I'm the Enforcer.

 

eqnmrt.jpg

 


#10 Jerod Poore

Jerod Poore

    Administrator

  • Chief Citizen Medical Expert
  • PipPipPipPip
  • 4,063 posts
  • Diagnoses:Bipolar NOS, Epilepsy NOS, Autism, Agoraphobia/Social Anxiety
  • Current Meds:LTG 200mg, TPM 250mg, protriptyline 30mg, MPH 5-10mg, buspirone 45mg EPA 600
  • Location:Saint Regis Montana

Posted 09 January 2008 - 11:23 AM

Well, part of that might be that they are pushing Invega, and it's awkward to push Invega while badmouthing your own other product you're handing out. They're still sampling Consta around here, though.


With Invega it's all the more reason for Janssen to just start making generic risperidone for schizophrenia and adult bipolar mania, while Invega starts getting approved for everything else Risperdal is currently doing.

Why?

Patient compliance. Invega is easier to take in that you take it once a day (vs. up to four times a day with Risperdal) and has fewer drug-drug interactions, fewer gastrointestinal issues than Risperdal, and supposedly you can just start at your target dosage.

So with Invega being a big improvement on the delivery method on what is essentially Risperdal, J&J / Janssen may as well manufacture generic risperidone themselves whenever an application goes off patent. That way they look like the good guys, less expensive risperidone gets on the market quicker, people shouldn't have to worry about the generic being of significantly less quality than brand, and Janssen gets and get to keep most of the money from the sales of generic risperidone.

Win fucking win all around.
  • 0
Jerod Poore - Owner, Founder and Chief Citizen Medical Expert of crazymeds.us
Keep up with Crazymeds and my slow descent into irreparable madness boring life via your preferred social media:

Wear my Straitjacket     Batshit Crazy Blog

I am not a doctor, nor do I play one on TV. No doctor, nurse, pharmacist or lawyer was harmed in the creation of this post. No warranty is expressed or implied. Not valid with any other offer. Void where prohibited.

Current meds: lamotrigine 300mg, topiramate 325mg, buspirone 60mg, protriptyline 60mg, EPA 600mg, methylphenidate 5-10mg, lorazepam 1mg PRN
Past meds (likely incomplete): Abilify, clonazepam, desipramine, diazepam, Gabitril, lithium, Neurontin, Paxil, prochlorperazine, Provigil, Prozac, Risperdal, Seroquel, Serzone, Strattera, Trileptal, Zyprexa

#11 Silver

Silver

    Would-be Neurologist

  • Members
  • PipPipPip
  • 905 posts

Posted 09 January 2008 - 01:42 PM

Rep says they're being told it's generic at the end of June 2008.

He'll look at the Orange Book risperidone page and explain the exclusivity dates to me when he isn't driving.
He doesn't think J&J is making it as an 'authorized generic,' but he isn't sure, "and they probably wouldn't tell us anyway."

He thought it was Barr who had the 180d first period, but wasn't sure... looks like it, though, from that press release.
  • 0
Bipolar I

Science is not about building a body of known 'facts'. It is a method for asking awkward questions and subjecting them to a reality-check, thus avoiding the human tendency to believe whatever makes us feel good. --Terry Pratchett

#12 In_Remission_Schizoid-Affectish

In_Remission_Schizoid-Affectish
  • Guests

Posted 25 April 2008 - 06:53 PM

dont think anyone has mentioned this, but we have "risperidone" up here in canada
(no im not trying to be an asshole)

the price is right and they work pretty good

the only difference i can tell is the sedative effect isnt as strong. you get good sleep(few to zero nightmares) but it doesnt zonk you out like the original


i really hope you guys get it soon, up here its pretty much half of the brand price

Edited by Schizoid-Affectish, 25 April 2008 - 06:54 PM.


#13 Jerod Poore

Jerod Poore

    Administrator

  • Chief Citizen Medical Expert
  • PipPipPipPip
  • 4,063 posts
  • Diagnoses:Bipolar NOS, Epilepsy NOS, Autism, Agoraphobia/Social Anxiety
  • Current Meds:LTG 200mg, TPM 250mg, protriptyline 30mg, MPH 5-10mg, buspirone 45mg EPA 600
  • Location:Saint Regis Montana

Posted 26 April 2008 - 07:34 AM

dont think anyone has mentioned this, but we have "risperidone" up here in canada
(no im not trying to be an asshole)


You're not being an ass. Anyone who doesn't have insurance and has to pay for their own meds can get meds via a Canadian pharmacy, and thus get meds that are generic in Canada that are not yet generic in the US.


the price is right and they work pretty good

the only difference i can tell is the sedative effect isnt as strong. you get good sleep(few to zero nightmares) but it doesnt zonk you out like the original


In my experience there is little, if any difference between Canadian generics and US brand medications.

i really hope you guys get it soon, up here its pretty much half of the brand price


Half the price for US consummers as long as the US dollar doesn't continue to plummet in exchange with the Looney.
  • 0
Jerod Poore - Owner, Founder and Chief Citizen Medical Expert of crazymeds.us
Keep up with Crazymeds and my slow descent into irreparable madness boring life via your preferred social media:

Wear my Straitjacket     Batshit Crazy Blog

I am not a doctor, nor do I play one on TV. No doctor, nurse, pharmacist or lawyer was harmed in the creation of this post. No warranty is expressed or implied. Not valid with any other offer. Void where prohibited.

Current meds: lamotrigine 300mg, topiramate 325mg, buspirone 60mg, protriptyline 60mg, EPA 600mg, methylphenidate 5-10mg, lorazepam 1mg PRN
Past meds (likely incomplete): Abilify, clonazepam, desipramine, diazepam, Gabitril, lithium, Neurontin, Paxil, prochlorperazine, Provigil, Prozac, Risperdal, Seroquel, Serzone, Strattera, Trileptal, Zyprexa


0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users


Shirts to swipe from Crazymeds' Clothes Line See more ways to let my meds express your feelings at Straitjacket T-shirts. Shirts, hoodies & more, $15-$51.
Batshit Crazy shirt
Batshit Crazy
Mentally Interesting shirt
Mentally Interesting
Medicated For Your Protection shirt
Medicated For Your Protection
Breakfast of Champions shirt
Breakfast of Champions
Brain Cooties Aren
Brain Cooties Aren’t Contagious


Keep Crazymeds on the air. Donate some spare electronic currency you have floating around The Cloud




Keep up with Crazymeds and and/or my slow descent into irreparable madness boring life. Pick your preferred social media target(s):
Follow Jerod Poore on Facebook
Wear my StraitjacketBatshit Crazy Blog
Crazymeds | Promote Your Page Too
Play Dress-Up with your Imaginary FriendsCrazymeds: The Blog