Epilepsy Foundation

Although some generics are better in regards to lesser side effects, if there is more than one company making another version of the generic drug you do not know what you will be getting.   I do not know as of know but back in 2002 the FDA allowed  up to +/-30 percent for a generic drug. Maybe it is +/-40 percent now.  Who knows.  Things are getting worse.  I don't know how long the patent of the original manufacturer is protected now.  It used to be 20 years before generics could be made.

I had problems in the past with generics throughout my years with epilepsy.  In 2002 I decided to go back to school and wrote a paper about generic drugs versus brand name drugs.  Although I already did research in the past and knew what to put in the paper, I still had to provide proof that I researched the information and was not making it up.  The references are within and at the end of the paper.

 

Overall, purchasing generics is a big risk.  Think of it as going to the dollar store.  You go in for toothpaste or a pair of socks that you previously purchased and were very pleased.  You want more but suddenly the dollar store has new brands of socks and toothpaste and doesn't have what you recently purchased.  Why?  Because they buy the cheapest products in bulk to make a profit, just like pharmacies that buy drugs in bulk with us not knowing what we are getting.  If you get a generic version that is controlling the seizures and you are happy with it, don't be surprised if you go into the same pharmacy and get another version of a generic.  This happened to me with Tegretol and to my husband with Dilantin  in the past.

 

See the attached paper.

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If you do find a generic manufacturer of a med that you can tolerate well, request that the pharmacist only fill it with that particular manufacturer.

Is there a minimum amount of time a drug must be on the market before other manufacturers are allowed to make the generic equivalent?

Phylis Feiner Johnson said:

It used to be 20 years before the patent expired but that was in the old days.  When I did the report in 2002 it was 17 years.  As of now, I do not know.  Somewhere I read it was 7 years but you can't believe everything that is on the Internet.  You may want to go to http://www.fda.gov/

Generic Patents in the FDA

http://google2.fda.gov/search?q=generics+patents&x=0&y=0&am...*

I'm on Lamictal, Clonazepam, and Keppra.  Lamictal became generic but that goodness my health insurance covers brand.  I heard Keppra is coming out with a generic and I just started taking it in 2002.  If we are forced to take generics that scares the living daylights out of me.  Many pharmaceutical companies are now making their own generics due to competition. 

You can go into the fda.gov and get daily updates by e-mail to prescriptions.  I do not recall the exact website.  The e-mail is comes from is   It has to do with food as well as prescriptions.

I have to agree with you I already Posted topics about this in men part of epilepsy.  I should of posted it here lol  http://epilepsyfoundation.ning.com/forum/topics/pharmacy-switching-...

 

Here the info I collected 4 months ago.  I wish I did more research.  http://www.webmd.com/epilepsy/features/epilepsy-medications-when-is...

 

http://www.msnbc.msn.com/id/30627962/ns/health-health_care/t/your-p...

 

For me, the scariest part is when your insurance company is trying to secretly switch you to the generic and you don't know if it will work for you. My insurance did that to me and they got a piece of my mind, at all levels. The different chemicals in the generic vs. name brand is huge when dealing with your personal chemistry. Yes, a person might be under control on both... but you don't know unless you try. I wouldn't try it unless I couldn't afford the brand. Luckily, I can.

Insurance companies need to respect prescriptions as they are written.

Hay Bethany.  What I was told by others with Epilepsy and generic or the orignal medication.  Is have the doctor mark the Prescription pad with brand name or a brand generic medication that works. like I am on Keppra Name brand medication.  But Trileptal Generic.  But make sure of is they can't Switch between differnt Trileptal generics.

 

A good website to know which Generics your taking.  is http://www.drugs.com/pill_identification.html

Even if you have been taking your medicine for years, always examine each refill before taking it.

The Url posted from http://www.drugs.com/pill_identification.html It tell you the Manufacture of your generic medications. 

I went to the cabinet, pulled four of my medications, input the numbers and letters into the box and everything came up correct.  I love this site.  Thanks for positing this. 

Too bad vitamins and other pills don't have codes on them.  It's too bad all the other pills such as vitamins, diet pills, aspirins and other pills don't have codes on them.  Many people die of aspirin overdose.

Well glad the website help Juanita B.  I found it when I started having seziuers on a generic keppra medication and I wanted to find out who manufacture it. 

Ya it dont work for over the counter medications. 

Let me start off by saying that I am on brand name Tegretol XR, eventhough there is a generic.

However I want to clear some things up about this subject.

Patent Vs. Exlcusivity

Patients last for 20 years from the date of filing.  However this is usually long before the medication comes on the market.  They are usually filed at the latest possible date, but usually while the medication is still in pre-clinical trials. (not in humans yet).  Exclusivity is granted by the FDA from the date of approval.  Length of Exclusivity is 5 years by default and can be effected by other things. (7 years for orphan drugs, and extra 6 months for pediatric approval)  Both of these must usually expire before a generic comes out.

Content of Generic drugs.

This is my pet peeve.  The FDA does not allow a variance of +/-30% in generic drugs.  Here is how it works.  Samples from the Generic manufacturer are tested for ACTUAL vs STATED content of the active ingredient. This is done by comparing total exposure of the generic (AUC) vs the brand.  The drug is approved if the 90% Confidence interval is between 80% and 125% of the average AUC for the brand.  Also, all samples must fall within this range.  THIS IS THE SAME REQUIREMENT USED FOR BRAND NAME DRUGS. The only difference is that with brand, the comparison group is the Theoretical AUC based on early clinical trials.

The Real Problem

The problem is not that Generics are bad, it is that they are inconsistent. Juanita talks about Narrow Therapeutic Index.  The problem with these medications is that sometimes a 1% or less difference can cause side effects or failure.  The advice I give is the same as many. If you use generic, always make sure you get the same manufacturer.  This is often indicated by the last three letters on your prescription label.  For example Phenytoin 100 mg Cap MYL is made by Mylan. If this is not how manufacturer is indicated on your labels ask your pharmacist. It MUST be on your label somewhere.  Also know that if you are controlled on a generic, switching to the brand is as likely to cause problems as switching to another generic manufacturer.

Hope this helps some people.  

Matt, PharmD Candidate 2012

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