FDA approves Mylan's generic Topamax

FDA approves Mylan's generic Topamax

There are 154 comments on the Newscom story from Sep 12, 2006, titled FDA approves Mylan's generic Topamax. In it, Newscom reports that:

Mylan said Tuesday the U.S. Food and Drug Administration approved its generic formulation of Ortho-McNeil's migraine medication Topamax.

Join the discussion below, or Read more at Newscom.


Kirkland, WA

#21 Sep 19, 2008
Well, people...I just wrote to Mylan, the company who will allegedly be selling the Topamax generic and we'll see if they respond!
I asked when the Generic will be available and mentioned what you guys mentioned...that Ortho is no longer sampling Topamax (my Neurologist's office told me the same thing after giving me bazillions of bottles).
So, keep your fingers crossed that they respond - I just wrote to CUSTOMER SERVICE in the "Contact Us" link on their website ( http://www.mylan.com/contact_us/ )...maybe you guys can do that same and they'll see that we're all interested and they'll post something on their website (I don't see anything!).
I even called my Rite-Aid Pharmacy to see if they knew anything and they told me that they don't get any advanced notice - they just see new drugs in the boxes when they open them!:(

Seattle, WA

#22 Sep 19, 2008
Well, well...how do you like that! No more than 2 hours after I posted this and sent the email to Mylan, their representative called me back!!!!! How's that for good customer service!?

She told me that at this point, there is no release date, but to keep an eye on their website and on www.fda.gov and to check back with them in a month or so.

That's not good news that she didn't know a release date, but it's great that she's so responsive.

She also said that they wouldn't know a release date until a few days before. Curious huh? It's like they have the pills sitting in bottles waiting at the loading dock at their warehouses just WAITING for the FDA approval to happen so they can ship them to the pharmacies. I bet that's not far from the truth since Ortho is no longer sampling Topamax proper.

Tick, tock, tick, tock...

Richardson, TX

#23 Sep 22, 2008
Please report back when you hear ANYTHING on the release of the generic in the US! My husband has lost his job, thus his insurance, and so I need the generic ASAP since I can no longer afford the Brand name.(Really couldn't afford it before, but there's nooo way now.)

Madison, MS

#24 Sep 23, 2008
Hey I know what you all are going throught but let me tell you something you may not know because Topamax is so expensive they have us over a barrel my daughter 14 takes Topamax for migraines and teens as they are forget to take there meds she has twice had a seizure do to not taking her medicine even though she does not have epilepsy one of the side effects of stopping cold turkey is onset of seizures and also panic attacks this I got from her Neurologist my son also takes Topamax for epilepsy it is so expensive that this week I am stuck on how to buy groceries because I am a single mom with a dead beat dad employer who has not been sending in the child support payments they are withholding from his pay check but I know my kids have to have there medicine and as soon as Topamax Generic is aviable my daughter will be able to take for her migraines my son will have to stay on the brand until Dr is sure of testing for epilepsy.

Saint Charles, IL

#25 Sep 30, 2008
Hey, I am not sure if anyone else has heard, but something recently happened where Johnson and Johnson got a patent increase until March of 2009 for Topamax it was based on something to do with pediatric exclusivity or something. I am not certain if this will have an impact on a generic becoming available for adults as well as for this certain pediatric age group or the specific details. At any rate, I suffer from chronic daily migraines, and take Topamax as well. I have been patiently waiting for the patent to expire on this medication because I am a single mom who goes to college, my insurance will not cover this med at all, my doctor has no samples, etc. I cannot afford this medication much longer, but at the same time I can't go back to the daily pain of having a migraine. If anyone hears any news please keep me informed.

United States

#26 Oct 1, 2008
Has anyone bought generic Topamax from Canada? If so, which website do you trust? Are the pills any different? I spoke with an American Drug Rep that said they can be trusted but am still nervous. Please let me know if any of you have been taking generic from Canada, and where....

Riverbank, CA

#27 Oct 2, 2008
As anyone esle taking this drug for depression and bipolar. I have just started. I am taking 100 miligrams. no side affects yet and what is your pros and cons?

Philadelphia, PA

#28 Oct 9, 2008
I have been taking topamax for 3 to 4 yearsas adjuntive treatment for MDD and PTSD. At the beginning the word finding problem was hard, its gotten some what better but its still there. Tingling has gone away. Because of the cost and I am in the medicare donut hole I can't afford to fill my RX I am waiting for a Shipment from Canada, hoping it will be equal in quality. But the withdrawl is aweful. I was taking 200mg but have taken as much as 400mg to elimate extreme nightmares everynight. Can't wait for the generic to be available in the US.

Denver, CO

#29 Oct 10, 2008
I lost my insurance temporarily while switching jobs and had to stop my topamax. In the few months that I have been off of it I have had two absence seizure and four migraines. I finally decided to order from a canadian site and am waiting for it to get here now. I also did my research and found that they are usually quite trustworthy and the drugs should be quality.

I cannot WAIT for a generic to be available here.

Stuart, FL

#30 Oct 13, 2008
I have contacted Mylan and Lupin Pharaceuticals who both have been approved by the FDA for Generic Topamax. They both indicated that they do have approval from the FDA, but neither had any idea when it would be available. Lupin did say they where in the manufacturing stages. Both of these companies got back to me very quickly by phone. I have alos contacted Walmart and Hy-Vee pharmacies and asked if they had heard anything. Both of them said they had not heard of when the generic Topamax would be available, but to keep calling back. My prescription insurance company said they do what I have been doing, GOOGLE to find out when the generic form is available. Hopefully it won't be much longer. The co-payments are killing me.
sherri cedar hill texas

Flower Mound, TX

#31 Oct 16, 2008
i too feel th money crunch. i take topamx for siezures. i too am waiting for the generic. my doctor said that he had gotten word that it would be soon even for my other medication keppra. lets hope he is correct. its breaking my bank as well.

Auburn, WA

#32 Oct 18, 2008
My wife takes Topomax for seizures and it is the best medication she has tried so far. Although we have insurance with group health it only gives $2000 prescription coverage so with the ridiculous price currently it has already reached that limit.

We are looking at buying in Canada. We phoned a few legitimate walk-in pharmacies in Canada (Safeway and London Drugs) and the price for generic is around $260-270 for 90 days supply (she takes 150mg per day). The online companies are selling the same amount of generic for around $170 but the problem is they source worldwide so you could end up getting it from India. Some of the online companies also seem very dodgy.

I am not sure what is the best thing to do. Has anyone ordered and received the Topomax they ordered online yet? If so what company name?

I also heard Mylan Pharmaceuticals got the FDA approval for the generic version in the USA but there is no news on a release date.

Tucson, AZ

#33 Oct 22, 2008
McCoubrey wrote:
As anyone esle taking this drug for depression and bipolar. I have just started. I am taking 100 miligrams. no side affects yet and what is your pros and cons?
I've been on Topamax for 2 yrs. The cons 1st: The word finding is the worst. I have a masters degree in psych nursing and it is really embarassing not to be able to come up with what I want to say. The cost. And the peripheral neuropathy -- but that does go away and sometimes with higher doses. Now the cons. I get lots more sleep. My moods are more stable.(I have PTSD, Cyclothymia [hypmania with chronic depression]) and I also weighed 287 lbs when I started on topamax and now weigh 192!. My anxiety is much less also.

Saint Louis, MO

#34 Oct 23, 2008
this has been the most informative site yet. I will keep checking back. It is very confusing out there. First there was one company for generic, now there are two. Mylan and now Lupin. But it looks like Lupin might come sooner after following Mylan all this time....
In the meanwhile. I have been on the God send Topomax for 7 years. It has saved me from a life threatening eating disorder.
I am currently in the insurance gap. The $320 a month are unbearable but ??? And this is paying half. What would I do if I wasn't computer savvy?
I tried the Canada drugs. And it messed up my menstrual cycle. I began bleeding a week later. And this of course sent my emotions all over the place. So I went back to taking the real stuff.

Fountain Hills, AZ

#35 Oct 27, 2008
Canada drugs online seels a good generic. no problems. the order comes in and the product works just like normal.
planet drugs; however, BAD NEWS!!! i had major headaches, seizures, weight gain, the whole nine yards. It's as if it were a sugar pill. I called and asked for a refund to no avail. I was furious! Oh yeah, they reresented themselves out of Texas on line, only when I called did I find out they were out of Canada. I don't like being misled.
I have total faith in Canada Drug. I have ordered 6 month supplies twice now.

Seattle, WA

#36 Nov 6, 2008
Hmm, I do NOT see mention on Mylan's website about getting approval for a generic TOPAMAX, instead I see a mention that they've gotten approval for generic Keppra!

Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppraź and Launches Immediately


PITTSBURGH, Nov. 4 /PRNewswire-FirstCall/-- Mylan Inc.(NYSE: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppraź.
Robert J. Coury, Mylan's Vice Chairman and CEO, commented: "We are extremely pleased to be able to monetize another first-to-file opportunity and to offer a more affordable alternative for patients. In addition, after our very strong performance in the third quarter, the launch of Levetiracetam is another significant step toward the continued execution on our stated goals for 2009 and beyond."
Mylan and UCB Societe Anonyme and UCB Pharma Inc.(collectively, UCB) previously had entered into an agreement to settle pending litigation relating to Levetiracetam Tablets. Pursuant to the settlement, Mylan was given the right to market the 250 mg, 500 mg and 750 mg strengths of Levetiracetam Tablets in the United States as early as Nov. 1, 2008, provided that UCB obtained pediatric exclusivity for Keppra and Mylan's ANDA obtained final approval from the FDA. UCB was granted pediatric exclusivity relating to the '639 patent, which extends to Jan. 14, 2009. Additional terms of the settlement are confidential.

Seattle, WA

#37 Nov 6, 2008
And I found this about Lupin:

BALTIMORE, May 30 /PRNewswire/-- Lupin Pharmaceuticals, Inc.(LPI) announced today that it has received tentative approval for the Company's
Abbreviated New Drug Application (ANDA) for Topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from the U.S. Food and Drug Administration (USFDA).

Lupin's Topiramate tablets are the AB-rated generic equivalent of Ortho-McNeil's TOPAMAX(R) tablets, indicated for the treatment of seizures.
The brand product had annual sales of approximately $2.2 billion for the twelve months ended March 2008, based on IMS Health sales data.

Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "Lupin is pleased to receive this
approval that will enable the Company to offer Topiramate tablets as an affordable generic alternative that will have a measurable impact on the U.S.
healthcare system."

The product will be introduced in the market through LPI's strong network of national wholesalers and drug stores post patent expiry in September 2008.
This will strengthen Lupin's presence in the CNS segment.

Well, it's past September 2008! Where is the drug!!!:)

Edmonds, WA

#39 Nov 13, 2008
I went to an Epilepsy Conference this weekend and a Neurologist spoke on Medications and he said, "we hope the Topiramate generic will be available this month". So, hold on - it's coming!

Matthews, NC

#40 Nov 17, 2008
I was told by my neurologist in late August that the generic Topamax will be on the market here in the States as of January 1, 2009. Hope that helps everybody.

Woodstock, GA

#41 Nov 17, 2008
I emailed Lupin to find out about there generic Topamax. I asked what it would be called and when can we expect it. Here is the reply I received:

Our generic is called Topiramate - but the generics will not be available until some time after March 26, 2009.

Best Wishes,

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