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Generic Lamictal -- Yes, it IS available!


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There seems to be a lot of confusion about this. I decided to start a new topic so everyone can easily find this info.

Lamictal is available as a generic called lamotrigine. So far it is only available in the Chewable Dispersible Tablet form. They are manufactured by Teva Pharmaceuticals. Here's the company's PR from February 17, 2005:

[url="http://www.tevapharm.com/pr/2005/pr_513.asp"]Teva Announces Settlement Of Lamictal

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Thanks for the info. I had posted elsewhere that my insurance co had shown a generic available but no one else thought that was correct - including pharmacist. Wonder if insurance co will treat chewable as an alternative to tablets - or just to the chewable Lamictal. Actual Lamictal chewables only come in 2, 5 and 25 mg. Wonder if it's the same for generic. I would guess so. Not very convenient if your dose is 200!

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Hi, Steve...

According to the product listing at Teva's US website: http://www.tevausa.com/default.aspx?pageid=28&pagenav=L so far Lamotrigine is only available in 5 mg and 25 mg Chewable Dispersible Tablets. Bummer. On the other hand, they're very tiny...swallowing 8 shouldn't be a problem. (I'm up to 4 1/2 at this point.) And just think! Ten dollars a month (or whatever your insurance has you co-pay for generics). Worth the trouble, no?

revlow

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Were you using "Lamictal" Lamictal before the generic lamictal? Did you notice any difference? Like you say, worth considering! Once I get up to a stable long term dosage and determine if I will continue I will compare costs. Wish Wellbutrin XL was available as a generic!

Thanks again for your information.

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Steve: You're more than welcome!

Were you using "Lamictal" Lamictal before the generic lamictal? Did you notice any difference?

<{POST_SNAPBACK}>

Unfortunately, I can't speak to that. I started with the generic lamictal (lamotrigine)when I first starting taking it. So, that's all I've ever known. I'd imagine there might be some adjustment.

Anyone else out there who can speak from experience?

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Wonder if insurance co will treat chewable as an alternative to tablets - or just to the chewable Lamictal.

<{POST_SNAPBACK}>

Steve:

I just re-read your message...somehow I'd overlooked this passage. Ooops. Anyway, at least with my pharmacy/insurance co. I believe they treat it as an alternative to the regular tablets. As I remember, my original prescription didn't say anything about "chewable". I'll be getting a refill this week...I'll ask. That is, if I can remember! ;)

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I just re-read the Teva press release I linked above. You know what? I think the "generic" available currently might actually be the brand version. (I know that sounds confusing, but bear with me...) Here's the quote that makes me think this:

"The terms of the settlement, which remain subject to government review, provide that Teva may, under an exclusive royalty-bearing license from GSK and on a date not later than June 2005, distribute in the United States a generic version of lamotrigine chewable tablets (5 mg and 25 mg). In addition, Teva was granted the exclusive right to manufacture and sell its own generic version of lamotrigine tablets (25mg, 100 mg, 150 mg, and 200 mg) in the United States with an expected launch date in 2008."

The italics and underlining are mine. Does this make any sense? This may be a completely erroneous assumption, but it sounds like they are now distributing GSK's own chewable tablets (under the Teva label), and in the future will have the right to manufacture their own generic version of the regular tablets. At least that's how I read it. Of course, I guess that also depends on what became of the "government review".

I will post anything I can find on this.

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From the semantics of their statement it would certainly look like your interpretation is valid. At least well analyzed. I've seen some pretty stupid statements from attorneys, though, even though they are paid to use language appropriately. So I wouldn't count on anything.

Good work!!

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From the semantics of their statement it would certainly look like your interpretation is valid. At least well analyzed. I've seen some pretty stupid statements from attorneys, though, even though they are paid to use language appropriately. So I wouldn't count on anything.

<{POST_SNAPBACK}>

Yeah, I just re-edited my post above to say: "...This may be a completely erroneous assumption..."  ;)
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hi revlow,

in regards to your quote, "distribute...a generic version" in my opinion means just that: generic. The difference between lamictal and a generic is a requisite concordance rate of 80%. If it's gsk's own batch, well, it's not generic, it's lamictal.

where are they getting the generic from: labs outside the u.s. maybe. if i can order an express delivery of generic from canada, a big co. like teva can do better no doubt.

There is another thread below announcing the release of generic Lamotrigine where the generic and brand are compared. I read enough to convince me to stick with what I know. Lamictal can be so delicate after all.

7

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I'm not sure if this answers the question, but I've found a few more pieces to the puzzle. Maybe someone else will know with certainty how to interpret this...

1) Looked again at Lamotrigine at the Complete Product List at Teva USA: http://www.tevausa.com/default.aspx?pageid=28&pagenav=L

2) Clicked on "Details" for both the 25 mg ( http://www.tevausa.com/default.aspx?pageid...716&ndcsub=5716 ) and 5 mg ( http://www.tevausa.com/default.aspx?pageid...715&ndcsub=5715 )

3) Each of these detail pages show a TEE (Therapeutic Equivalence Evaluations) Code: n/a (2)

4) Looked up "n/a (2)" at Teva's TEE Ratings page: http://www.tevausa.com/default.aspx?pageid=30 -- according to this, n/a (2) means Therapeutic equivalent, manufactured and distributed under originator's NDA.  (NDA = New Drug Application.)

So, again I may be wrong...but it looks like the case for it actually being the same drug is growing??? Especially when you read the other types of TEE codes listed, which can get very convoluted in terms of "bioequivalence".

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Hi, 7...

I posted my last message before I noticed yours. If you wouldn't mind, could you please read what I said in it and let me know what you think? I'd be most interesting in what you think "Therapeutic equivalent, manufactured and distributed under originator's NDA" means. (Believe me, I'm not claiming I know.)

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Hi, 7...

I posted my last message before I noticed yours. If you wouldn't mind, could you please read what I said in it and let me know what you think? I'd be most interesting in what you think "Therapeutic equivalent, manufactured and distributed under originator's NDA" means. (Believe me, I'm not claiming I know.)

<{POST_SNAPBACK}>

yeah, read it. we're cross-posting, like phone tag ;) um, well, the next place i guess it takes you is what are the fda requirements in an nda? does every chemical, amount, and process have to be totally spelled out? the parts that are slippery in my mind are "therapeutic equivalent" and "under."

Maybe, GSK is going to produce, under its own NDA, a special lackluster batch for TEVA to distribute? Or, authorize TEVA under its NDA to go get a therapeutic equivalent? Or your scenario?...the possibilities are endless. 

But your plans to talk to someone at those companies sounds promising. TEVA, GSK, the FDA, the pharmacist...get 'em all talking!

Thanks again.

7

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But your plans to talk to someone at those companies sounds promising. TEVA, GSK, the FDA, the pharmacist...get 'em all talking!

<{POST_SNAPBACK}>

LOL. You betcha...I'll get 'em all spillin' their guts! ;)  

I hope I'm not generating any false hope (for others) in this pursuit. We'll just see where it takes us, eh?

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just one more thing: the pills shown have TEVA stamped on them...your guess is as good as mine B)

<{POST_SNAPBACK}>

Yup. I'm beginning to get more skeptical about my own thoughts on this subject. That or I'm just having a bad, bad night. Can't sleep, had a bad anxiety attack a few hours ago, and now I just completed a long jag of sobbing. Gee...this is fun.

Remember, for those of you just tuning in, I am not yet at a therapeutic dose. So, for more reasons than one, please take everything I say with a grain of salt.

I think for folks (like me) who either have been taking the generic from the start, or for those about to start taking Lamictal/lamotrigine alltogether, it's probably save to say it's okay. Since the generic is all I've known, this is what my body is used to. If indeed it does not have the same bioavailability, what level I'm getting is still consistant. So if, for example, I eventually have to take 20% more than I would have needed of the brand version to get a therapeutic level, no problem. As long as the ultimate result is the same.

Obviously the real Q is for people already on the brand version, as that sort of change could be drastic. And to that end I will do my best to get a definitive answer.

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Hey Revlow and 7

Keep up the good work! Really greatful!

See pdoc in 4 days (wed) and will need new Rx and have only been on starter pack. So - IF things look OK it might be good to switch now. It's easy to dismiss the costs - in my head - but when I start adding up all "med" costs - including supplements etc - then If I could find a way to save a little on each one it might make a big diff on the "bottom line". I do have limited income and all the expenses are draining "savings".

As always, Thanks to you both!

Steve

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Steve: You're more than welcome!

Were you using "Lamictal" Lamictal before the generic lamictal? Did you notice any difference?

<{POST_SNAPBACK}>

Unfortunately, I can't speak to that. I started with the generic lamictal (lamotrigine)when I first starting taking it. So, that's all I've ever known. I'd imagine there might be some adjustment.

Anyone else out there who can speak from experience?

<{POST_SNAPBACK}>

Only one experience of both that I know of: here

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Thanks, "unreg" - I should have caught that!

That's always sort of been my position (branded as opposed to generic) but some generics are closer to the branded than others. As I said, costs are adding up! but I guess the only way to really tell is try for yourself - or bite the bullet and stay on branded!

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Okay everyone, here's the skinny...

I spoke with the Manager of the Medical Affairs Division of Teva Pharmaceuticals USA.

1) She said their lamotrigine is manufactured by Penn Labs, which is a division of GlaxoSmithKline.

2) I asked her if there were any bioavailability reports, and she said no -- there are none because it is the same med, it is not a therapeutic equivalent.

3) She went on to say that as a result of the legal settlement, it is under the same NDA, and they are distributing the identical med as GSK.

So that's Teva side of the story.

I'll talk with my doc and pharmacist next time I see them, to see if they can add anything. Maybe I'll call Penn Labs & find out what they have to say. If needed I'll call GSK, but my gut instinct is they would be the least likely to give a straight story since they have the most to lose. (Okay, sure Teva has something to gain by telling me what they did, but it also just might be the truth.)

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They, um, look the same except for the markings and the 5mg caplet lacks the score line; the seemingly identical size, shape, and color appears a bit strange for a straight generic. I wonder if they taste the same

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UPDATE: Just spoke with GSK. Said they have no info and referred me to Teva. Did not have a phone # to give me for Penn Labs, am trying to find that now. She did confirm that Penn Labs is a subsidiary of GSK. Asked her if they manufacture the brand version; she said no, GSK does that themselves.

So, indeed, there are 2 manufacturers. And one of them is a subsidiary of the other.

Are we having fun yet?  B) 

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Still can't find the phone # for Penn Labs. Teva is already closed for the day. Have done all my usual researching tricks on the Internet, to no avail. I don't know if it's really worth talking with them, what they would have to say. But you never know.

When I spoke with GSK, I did find out Penn Labs are located in Zebulon, NC. (So at least they aren't located in some 3rd world country, which is a relief.) I just called directory assistance for that part of NC (919 area code) and they don't have a listing. Ah...the mystery continues. If anyone else has any ideas, please let me know.

Yes, Steve...I've got amazing abilities when it comes to researching anything. That, and all the loose change I can find under my sofa cushions, just might get me a cup of coffee! I haven't been able to keep a job for any real length of time in years, and have been out of work since May. In other words, I am really hoping this Lamictal/lamotrigine works!

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At least for now, substituting generic for brand at any time you use a Lamictal tablet of at least 100mg is a very bad idea if you pay out of pocket. For those with insurance, I wonder if the insurance companies will bite on a straight out substitution in larger quantities and, if so, for how long. Eight 25mg tablets of generic lamotrigine is $630.52 for 30 days. One 200mg tablet of brand Lamictal for 30 days is $125.47. These numbers are from my insurance company; you might be able to get slightly better pricing by doing a little shopping.

Todd.

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Forgot...I was going to post this attachment. Found the physicians prescribing info (you know, the real scary stuff that just makes you want to run away and never ever take another pill again?) for the generic. It's the same old same ol'. Nothing new. But I am posting it just so folks can see the bit at the bottom about Penn Labs, Inc. (a GlaxoSmithKline company)

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That's weird...I can't get the attachment to attach. I'll try again.

--------------------

Later:

Hmmm....it's not working. Anyway, all I was pointing out was that at the bottom it said:

Manufactured by:

Penn Labs, Inc. (a GlaxoSmithKline company)

Zebulon, NC 27597

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At least for now, substituting generic for brand at any time you use a Lamictal tablet of at least 100mg is a very bad idea if you pay out of pocket. For those with insurance, I wonder if the insurance companies will bite on a straight out substitution in larger quantities and, if so, for how long. Eight 25mg tablets of generic lamotrigine is $630.52 for 30 days. One 200mg tablet of brand Lamictal for 30 days is $125.47. These numbers are from my insurance company; you might be able to get slightly better pricing by doing a little shopping.

<{POST_SNAPBACK}>

God knows how much it varies between ins. co's. With mine in Nevada (Benicorp, which uses EnvisionRxOptions for the prescription meds) they charge me the same $10 co-pay, no matter how many I need for each refill. Since I'm still titrating up, I'm getting more and more each time. Same $10.

Of course, the rest of my insurance benefits suck. I wish there was some kind of decent regulations that would help us all. But that's a whole other topic, and one that our lovely elected officials have been unwilling to attack for how many decades now???

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Yup!

I won't get into that topic, either! But it's interesting that there are so few times when government "regulates" something that they don't make it worse, more complicated and more expensive! - or else they just pass the costs on to someone who is not using the service so everyone that uses the service will think it really was "a good deal"!

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I won't get into that topic, either! But it's interesting that there are so few times when government "regulates" something that they don't make it worse, more complicated and more expensive! - or else they just pass the costs on to someone who is not using the service so everyone that uses the service will think it really was "a good deal"!

<{POST_SNAPBACK}>

LOL. Couldn't agree more! (Notice how I qualified it with the word "decent" regulations) ;)

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The pharmacist's name is Jim Witt, and the pharmacy is:

Borg Drug

Ashby, MN 56309

Tel: (218) 747-2988

Found two addresses -- don't know which is correct yet:

1) 102 W MAIN ST

2) PO Box 170

...as well as a website: http://www.borgdrug.com -- but I havn't been able to get on to the site yet. I'd imagine their server has been bombarded.

It's really worth reading it, but thought I'd give you an excerpt from the CBS Evening News story A Prescription For Price Relief to show why this may apply to us:

------------------------------------------------------------------------------------------

"There's no gimmick. Instead of charging what the drug companies suggest for their generic drugs, he charges about what he pays.

Imagine

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I just sent an e-mail to them asking that they change their download price list to PDF

since Excel spreadsheet is not readable by Mac users unless we happen to have Excel on our computers.

Don't expect a quick reply after all the publicity. Only option for Mac users right now appears to be calling - which I'm guessing would be futile right now - unless he recently hired a large phone bank!

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Can't compare on Lamictal because I haven't filled an Rx yet -

But 87.00 for 100 Wellbutrin XL 150 is about what I think the price was for 30 at pharmacy!

Maybe you should start a thread JUST for this pharmacy info as it might provide a LOT of other pharmaceuticals that people on these boards use at way cheaper prices - especially for those who don't have insurance.

Don't know if the file size of the file is small enough to work as an attachment for PM's on this site, If not, not sure that we want to give out personal e-mails to everyone who wants info. May be a "quandry"!

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Steve:

Yup...I don't know what to say about this. I still can't even get on their website, but then you had no problems. It might actually be my computer. I have high speed access, so that's not it -- but I find I have problems getting on certain sites. I'll check this site on a friend's computer.

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Still can't find the phone # for Penn Labs. Teva is already closed for the day. Have done all my usual researching tricks on the Internet, to no avail. I don't know if it's really worth talking with them, what they would have to say. But you never know.

When I spoke with GSK, I did find out Penn Labs are located in Zebulon, NC. (So at least they aren't located in some 3rd world country, which is a relief.) I just called directory assistance for that part of NC (919 area code) and they don't have a listing. Ah...the mystery continues. If anyone else has any ideas, please let me know.

Yes, Steve...I've got amazing abilities when it comes to researching anything. That, and all the loose change I can find under my sofa cushions, just might get me a cup of coffee! I haven't been able to keep a job for any real length of time in years, and have been out of work since May. In other words, I am really hoping this Lamictal/lamotrigine works!

<{POST_SNAPBACK}>

Zebulon is an hour away from me.  I have never heard of Penn Labs but there is a Glaxo in Zebulon.

I am wondering if the chewables have phenylalamine in them.  I know that meds that are dissloving have it.  I'm allergic to it.

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WOW....

I just came across a PDF presentation that may explain a lot of this, especially from the financial incentive side for GSK. Haven't read it all yet, but just glancing over it, it makes a lot of sense. The presentation is called "Authorized Generics" and it was from the The 5th Generic Drugs Summit in Sept. 2004. You can look at it or download it here:

http://www.iirusa.com/genericsummit/files/...016_Worrell.pdf

It's pretty interesting. Don't know if it answers any of our basic Qs, but might add to the understanding of what's going on re: GSK/PennLabs/Teva.

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Two more pieces of reading material:

1) Here is a link to the Wall Street Journal article "Drug Makers Use New Tactic To Ding Generic-Drug Firms" (mentioned on page 2 of the "Authorized Generics" presentation): http://faculty.msb.edu/homak/HomaHelpSite/...WSJ_1-27-04.htm . Unless you have an online subsription to WSJ.com, use this link (or you'll have to pay for the article at WSJ.) *

2) Here's a similar (but much shorter) discussion re: Penn Labs generic version of Wellbutrin SR: http://www.dr-bob.org/babble/20050527/msgs/505292.html

*LATER - Found a good PDF version of the WSJ article (looks like an official reprint, easy on the eyes to read):

http://classwork.busadm.mu.edu/Economics%2...rug%20firms.PDF

I think this is essential reading to understand this new "authorized generics" relationship between companies.

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While by no means definitive, I am willing to accept this as a match:

Here are the ingredients for generic lamotrigine according to my friends at Teva:

"Lamotrigine Chewable Dispersible Tablets are supplied for oral administration. The tablets contain 5 mg (white) or 25 mg (white) of lamotrigine and the following inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate."

Here are the ingredients for brand Lamictal according to my friends at GlaxoSmithKline:

"LAMICTAL Chewable Dispersible Tablets are supplied for oral administration. The tablets contain 2 mg (white), 5 mg (white), or 25 mg (white) of lamotrigine and the following inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate."

I may, of course, be wrong, but I based on this information I am willing to switch from brand to generic for the 25mg part of my 225mg daily Lamictal ingestion, and, as a rule, I hate generics.

So, thank you revlow, you saved me over twenty dollars a month!

Todd.

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I may be wrong, but I think we have an answer.

<{POST_SNAPBACK}>

Seems that way, or at least leaning toward an answer ;)

Tod and Steve:

Please check my last posting with two other references. I just updated it, and I think we've crossed paths/played telephone tag.

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Zebulon is an hour away from me.  I have never heard of Penn Labs but there is a Glaxo in Zebulon.

I am wondering if the chewables have phenylalamine in them.  I know that meds that are dissloving have it.  I'm allergic to it.

<{POST_SNAPBACK}>

Hi, firedancer...

I just checked the physician's prescribing info (you can get the PDF file here: http://www.tevausa.com/assets/teva/PI_Lamotrigine.pdf ), and here are the inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate.

So at least from my uneducated eye, it looks like you'd be safe. I guess they are using saccharin sodium instead of phenylalamine as a sweetener? (I'd always thought that was such a stupid idea using phenylalamine as a sweetener since so many people can't take it. Plus it tastes like shit!)

Thanks for the info on Glaxo in Zebulon! I'll give that a try. Was an up-and-down day for me for me -- didn't get back up till it was too late to call back east (I'm Pacific Time), so no progress today. Will see what I can find out tomorrow.

<{POST_SNAPBACK}>

Blah - I can't have saccharin either.  You would be amazed at how many products out there have phenylalamine in them.  I can barely find a gum that I can actually chew!

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<{POST_SNAPBACK}>

Blah - I can't have saccharin either.  You would be amazed at how many products out there have phenylalamine in them.  I can barely find a gum that I can actually chew!

<{POST_SNAPBACK}>

Ooooh, bummer.

<{POST_SNAPBACK}>

I will have to tell my pdoc to be careful when writing the script.  My insurance company doesn't give me choice if there is a generic available.

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Revlow -

My previous comment was regarding your references. Todd's post, however, did get done while I was in the process of posting. Fun and fascinating and informative. I wish more people were seeing this thread because I think there may be big $$ to be saved on other meds through that pharmacy!

Steve

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Revlow -

My previous comment was regarding your references. Todd's post, however, did get done while I was in the process of posting. Fun and fascinating and informative. I wish more people were seeing this thread because I think there may be big $$ to be saved on other meds through that pharmacy!

Steve

<{POST_SNAPBACK}>

Yeah, I kind of figured that after re-reading your message. (Just wanted to make sure, too, that you saw my link to the PDF version of the WSJ article. I like nice, pretty things...oops, I digress.)

I think a great deal of the savings could also be had by people with these "authorized generics", that is those like lamotrigine that (at least as far as we can tell) appear to be identical, made by the same company, etc.

Maybe when all is said and done, I will tried to summarize this issue and post someplace central, or??? Any ideas welcomed.

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Guest luli2545

Sure, centrally post the information. I'm just starting on Lamictal and I pay out of pocket. Have no idea what dose I'll wind up on...but I'm really interested in your findings.

Thanks for all your work!

Luli

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I'm not sure if this answers the question, but I've found a few more pieces to the puzzle. Maybe someone else will know with certainty how to interpret this...

1) Looked again at Lamotrigine at the Complete Product List at Teva USA:

4) Looked up "n/a (2)" at Teva's TEE Ratings page: http://www.tevausa.com/default.aspx?pageid=30 -- according to this, n/a (2) means Therapeutic equivalent, manufactured and distributed under originator's NDA.

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Chinacat:

Thank you so much! Your professional knowledge puts to rest this hotly contended issue. Admittedly, I was taking a stab in the dark -- your fact based conclusion was merely my gut instinct.

Thanks again,

revlow

PS - Today you are DA WOMAN...I mean "DA PERSON"!!  B) (Inside joke)

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Awww, c'mon Rev!

What's with all these "inside jokes" I see among women!

Jeez, if guys did that we'd be hearing about "sexism" in 2 seconds flat! ;):):P

Let us guys (in the male sense, not the all-encompassing generic sense!) in on the joke so that we can learn an appreciation of the feminine mind! :ninja:

(Please know that this is more tongue in cheek than "serious" in case people have not figured me out by now!)

Steve

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Wow! Cute! (He said, preparing to be bashed over the head!  ;)

(I'm same age! - I promised myself I would not say that again on these boards so as not to dampen my ability to flirt with all the youngsters!  :) )

I should look so good! (actually, for all you people reading this, I'm dashing and handsome and look half my age!!!) (Riiiight!)

Sorry to go OT!

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