Hi! I went to reorder hubbys Razadyne and the pharmacist told me they now have a generic for it so that Medicare went up to $72.00 on it instead of $60. but if I wanted she would see if she could get the generic in a day or two. I had enough to get us by so she did. When I went back to get the generic, it was only $4.00!!!! I was SO excited! This will help us out so much! When I got home, I opened the bottle to see what the new generic looked like and it is IDENTICEL to the Razadyne. Same number on the pill and also same company. You could not tell the difference! Then you wonder if they have just ripped us off all this time! The pharamcist told me without insurance Razadyne would be $249.00! decblu
Thanks, Sunshyne. I'll bet our insurance will no longer cover Aricept since Razadyne will be available in generic form. My DH has done well on Aricept and Namenda. I don't really want to change but may have to. Do you know why some people are prescribed Aricept and others Razadyne?
I think doctor's preference. I'm pretty sure mine chose Razadyne because he has less problems with it and/or because he likes how it combines with Namenda better. And/or he has found it has fewer bad interactions with the raft of other drugs my husband was already on the first time he met him. Or he just happened to have a sample starter pack for that drug when my husband had his first appointment and it was the luck of the draw.
The real problem here is that the doctors really don't have a lot to go on.
Patent law is extremely complex, and the length and type of protection it affords involves a lot of different issues, including when the patent was applied for, what it covered, and whether its claims can be defended. A company may patent a general type of compound (e.g., any compound that inhibits cholinesterase) for a particular application (e.g., treating Alzheimer's) or it may patent a new class of compounds that inhibit an enzyme (that is, compounds that have a common "core" structure but different modifications to the core), or it may cover a particular compound. Or a patent may protect a specific formulation that contains a particular compound, whether or not that compound was already patented by someone else and whether or not that compound has already lost the original patent protection. Or it may protect the method for isolating/purifying a "natural" compound or for synthesizing a synthetic compound may be protected. Or it may cover a new way to administer the drug (oral, nasal, intravenous, skin patch, etc.), or it may even cover a device for administering the drug (a fancy type of needle, say.)
If a "new" patent in any of these areas is considered to be a simple improvement over an existing patent (say, a new way to isolate a natural compound), then the protection extends from the time the original patent application was filed, not the time the "improved" application was filed. It takes skill to convince an examiner that a patent application is novel, and not a continuation of (improvement on) a previous patent.
Among other things. <grin>
Then, of course, the length of time the patent is enforceable depends on when the patent application was filed. The patent laws in the U.S. have changed. It used to be that a patent protected an invention for x number of years (I think 17) from the time the patent actually issued. So you could file an application very early in the drug development process, and then take your own sweet time in actually getting the patent to issue. To bring the U.S. more in line with international law, this has now been changed to y number of years (I think 20) from the date the application was originally filed. (You can get an extra year by filing a "provisional" patent, but then you have to file the full application within that year to get the 20 years' protection.) And the first company to file is the one who gets the patent protection. So now, an inventor has to play Russian roulette, waiting as long as s/he dares to file (to extend the time the invention is protected) and hoping that no one else files in the meantime (or s/ne loses all.) If you file too early, you may have very little protection left by the time you've gotten the drug through clinical trials.
A patent is also only as good as the company's willingness and ability to fight infringement. Just because a patent was approved does NOT mean that someone else can't come along and get the patent thrown out. New information may have come to light that invalidates the original patent ... or the patent examiner may not have done a good job during his/her review, and the patent may not be defensible. Examiners have extremely heavy case loads, and are given very little time to review any single application.
Moreover, a given drug formulation, such as Razadyne ER or Aricept, may be protected by multiple patents, not just one. So any company that wants to sell a generic has to either wait for all of the patents protecting that drug to expire, or they have to go after the most vulnerable patents by filing lawsuits, and hope that their legal counsel does a better job of arguing the law than the opposition's.
You see.
I haven't followed all the intricacies of patent protection for these drugs to have the slightest idea why Razadyne lost protection and Aricept isn't expected to go off-patent for another couple of years.
Cognex was the first to receive approval, in 1993. It is still available, but no longer actively marketed by the manufacturer, since it has severe side effects that make it difficult for patients to tolerate it.
Aricept was approved in 1996. It has far fewer side effects than Cognex, so it rapidly gained acceptance by the medical community.
Razadyne wasn't approved until 2001. By this point in time, Aricept was very well entrenched. Besides, there don't appear to be very many significant differences between the two -- on average, they are equally effective, and have the same rate of adverse side effects. Doctors were used to prescribing Aricept, and the public was used to asking for it (lots of effective advertising.)
Moreover, the makers of Aricept were continuing to do lots of clinical trials. The first FDA approvals for both Razadyne and Aricept were for early- to mid-stage AD. By the time Razadyne was beginning to penetrate the market, Aricept had won approval for treating late-stage AD ... so Aricept had another leg up on Razadyne (and Exelon). And they were, I think, the first to show that a combination of their drug plus Namenda could be more effective than either drug alone. I'm not sure the other cholinesterase inhibitors have been tested in combinations in clinical trials yet.
Razadyne, on the other hand, is "new" and lots of people think new is better. And the people who make it have done a bunch of lab studies that show it may have several modes of efficacy that have not been demonstrated for Aricept. (But the different modes do not appear to make it any more effective overall, in the few side-by-side studies that have been done.) Since Razadyne is a different drug, it does have a somewhat different pharmacology, which means that patients who cannot tolerate Aricept may do well on Razadyne. So Razadyne is making inroads in the AD market.
Exelon (administered orally) was approved in 2000. It tends to have more gastrointestinal side effects than Aricept, so it did not do as well. The Exelon patch helps avoid gastrointestinal irritation (since the drug gets into the bloodstream via the skin, rather than the gut), which can make the Exelon patch attractive to patients who develop adverse gastrointestinal side effects with Aricept or Razadyne. Also, of course, it's easier to put a patch on a cranky AD patient than getting him to take a pill. The patch was not approved until 2007, however, so it had quite a way to go to gain wide-spread acceptance.
I'm not complaining since it is the one my husband is on and between that, and the likihood that his family doctor is going to start removing some of the other drugs he takes, we might not hit the donut hole in 2009. Good news for me even in the early part of the year since I no longer will pay the full price for the drug.
Starling, the couple of news items I've read about Razadyne going generic were as clear as mud. As far as I understand it, Ortho-McNeil has the rights to a key patent to galantamine hydrobromide (Razadyne). Barr Laboratories and AlphaPharm Pty Ltd. filed Abbreviated New Drug Applications ("ANDAs") to market galantamine before the expiration of the patent, claiming the patent was invalid. Janssen, Janssen Pharmaceutica N.V., and patent owner Synaptech Inc. filed a patent infringement complaint against Barr and AlphaPharm in June 2005. Janssen et al were also suing other companies trying to get approval for generics. If Barr Labs and AlphaPharm won, then the other lawsuits were basically won, if not, then they were lost. Barr/AlphaPharm came out on top. It is my understanding that although Synaptech received approval on their patent application, somebody else (presumably AlphaPharm) had actually filed their own patent application first. It's the filing date that counts in the long run. Since Synaptech was NOT the first to file, their patent isn't valid. No patent, no protection, and so any other company can start developing generics.
Now, what I haven't seen anything about is why the key Razadyne patent was due to expire in December 2008, but the key Aricept patent(s) aren't due to expire until 2010. Quite possibly, Synaptech filed their patent application in a big, fat hurry because they were afraid someone else would do it first, and the clinical trials and subsequent FDA evaluation took forever, so Razadyne didn't get to market for a very long time.
They may have had trouble getting Razadyne approved by the FDA, I don't know, haven't looked. For a new drug to be approved, it has to (theoretically) have significant advantages over current drugs. It's not enough for the "new" drug to simply "work". It has to be more effective, or have fewer side effects, things like that. This is a pretty gray area, and hard to prove or disprove.
Or the first formulations they tested may not have done well. Many things affect whether and how well a drug will work, such as the dosage (how much and how often it is given), other components in the formulation, how the drug is administered (orally, intramuscularly, intravenously, inhalation, cream/ointment, etc.) A drug can fail a clinical trial miserably, be re-formulated (or just retested at a different dosage regimen), and work like a charm.
Once the patent application has been filed, the clock is ticking. A drug company can lose a lot of the patent protection period while it is doing all the things that are necessary to develop the drug and get it through clinical trials and the FDA approval process.
But if they wait to file, in order to delay the starting of the clock, they may end up without a patent at all...
My husband was given Razadyne over Aricept because of possible stomach problems that those with Aricept sometimes have if they have had stomach problems in the past.
I just switched my DH from Aricept to the exelon patch because of stomach problems. We had out first experience with hallucinations a couple of days ago and I'm wondering if stopping the aricept had anything to do with it. He is still on the introductory dosage of exelon.
I switched my DH from Aricept to the exelon patch for about a week and then switched back because he became like a zombie, could not keep his balance and was more confused. He might have did better by leaving him longer but I didn't want to take the chance.
Our FD said I should keep him on the Aricept. I am thinking we might try the Razydine next spring because of the cost. Right now I have 3 months of Aricept. Wonder if you can alternate them for a week or two and have a easier adjustment?
Yes, after about 3 days. How do you know if the med was the cause? I don't know. He has been in a less confused state for 6 weeks now until this weekend and he is back to the confusion again. (Not like the aricept)..
Well after reading this post a few days ago, while I was a wallie world yesterday I thought I would check about Dh's . I went to the consultation area of the pharmacy. Of course I was told NO to begin with, then the dim wit concluded that hey maybe I was right there is a generic. Though she informed me that it wasn't available in his mg. So I asked what would be the difference? Ahhhhhhhh, give him two pills instead of one a day, I was like, well that would be ok if there is a savings between the two. I said I would like to compare the price of the Razadyne to the price of the generic, I explained that we don't have insurance and it would be nice to get it cheaper by getting the generic. She informed me that it really wasn't a significant savings and shot me a look like I was wasting her time. I again asked what the difference would be, she proceeded to inform me that we could get the generic for $178 ish. Helllooooooooooooooo, currently we pay $234 for Razadyne the generic is $178-ish. I said, you don't think a $50 some dollar savings is significant? I then proceeded to tell her,,,,,, I didn't know Bill Gate's is your Papa, I am not related, so in my world $50 dollar savings is significant and walked away. I was so flippen mad. I had other shopping to do. so I did end up telling a manager just cause I thought I needed to say something, though I don't think it will go very far. Well the maddness brewed as my day went on, so later in the day I was in another area of town, I thought, I am going to check other pharmacy prices. So I ran into target and asked about the generic for Razadyne, not only do they have it in the mg he currently takes, it's a $99 savings. So guess what, I am moving his prescriptions to target. Wallie world can take their pharmacy and stick it! Rk
I honestly can't believe someone would think that a $50 some dollar savings is not significant. For goodness sake the nim wit works at wallie world. Unless wallie world is paying better than I thought. I am just glad I happened on this post cause I don't think they would have offered it to me. Rk
I asked my husband's doctor about the generic for Razadyne replacing Aricept that he takes now and he said that would be fine and wrote his new Rx for the Razadyne. He also takes Namenda. So now being the worry-wart I am, I'm wondering if it will be the right thing for him. I don't want him to lose any memory he has because I switched his med to save money! I would say he's at the beginning of late-stage Alz. He goes to adult daycare while I'm at work and cannot be left alone, needs complete guidance, but is still doing okay in lots of ways...cannot converse much but sometimes I can figure out what he's trying to tell me. He's very healthy except for the Alz. and eats well and gets around well. He is 64 years old and has had Alz. for about 10 years. The Aricept is almost gone and I have the new Rx for the Razadyne. From what I just read above, it sounds like the Razadyne will be fine. Has anyone noticed their loved one going downhill with the change from Aricept to Razadyne? I love this website and wish I had more time to read what everyone says about everything!!!
The only negative side effect I have read regarding galantamine/Razadyne is an increase in heart attack. Going by a heart attack would definitely be better than going the course of this horrible disease. I decided that would be a better chance to take. I also give hb an acid reducer. Galantamine/Razadyne created more stomach acid, as I am sure Aricept does, that is why the stomach upsets.
My husband's neurologist tended to use Razadyne because he had fewer bad stomach problems with it. The combo with Namenda works fine. My husband is now on the generic.