Ampyra: A Generic for the MS ‘Walking Drug’ Wins a Round in Court

Ampyra: A Generic for the MS ‘Walking Drug’ Wins a Round in Court

MS_Wire_Ed_Tobias

Ampyra is marketed as the only multiple sclerosis (MS) drug that is designed to increase an MS patient’s walking speed. Clinical studies show that patients who use the drug walk as much as 20 percent faster. Ampyra improved my speed, several years ago, when I was on it.

But, like all MS drugs, Ampyra is expensive. If you’re not eligible for co-pay assistance, your out-of-pocket costs can run around $500 a month. That’s why I stopped using it. But a March 31 court decision may pave the way for the sale of a lower-cost, generic version of Ampyra (dalfampridine).

A federal judge has struck down four key patents that drug manufacturer Acorda Therapeutics holds on Ampyra. Those patents have to do with the methods used to deliver the drug to a patient — and the judge ruled that Acorda’s methods weren’t unique enough to warrant a patent. The judge did let stand another patent covering the drug, but that patent is due to expire next year anyway. The patents that were invalidated Friday weren’t due to expire for another 8-10 years.

The ruling has given hope to 10 rival drug companies that want to sell generic versions of Ampyra. Two of those companies, Roxane Laboratories and Teva Pharmaceuticals, challenged the patents in court.

Acorda’s CEO says his company will appeal Friday’s ruling. “We are disappointed by the court’s decision and are preparing our appeal,” Ron Cohen, MD, said in a news release. “Medical innovation depends on the recognition of valid intellectual property claims. We believe that we demonstrated novel and unexpected findings in our Ampyra development program that led to the issuance of valid patents.”

It’s unclear whether an appeal will delay release of the generics that Acorda’s competitors have been building. But I certainly hope that it doesn’t hold things up too long. I’d love to have an affordable generic of Ampyra available. I’d quickly ask my neuro to prescribe it so that I can walk a little faster and easier again.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.

32 comments

  1. Jan-Michael says:

    As Ampyra is essentially the chemical that was used to kill birds at airports, I found the drug caused greater problems in my MS after an initial improvement in walking speed. That made sense once I new what I was ingesting. I will never take Ampyra again. It took weeks to get the drug side effects cleaned from my body and I almost thought I had set myself back 6 years from good exercise and other non-drug efforts. Thankfully, my brain and other organs recovered and I was out of the fog and able to walk
    again, albeit slower.

    • Mike says:

      What were people’s side effects on the Ampyra? I am having some but trying figure out if they might be from this medicine or others.
      I was on the assistance plan and found out the last time I received the drug that the assistance The said they were only paying $1000 per month so I could they wanted me to pay $3600 which I can’t afford on disability. Told me the Ampyra cost $6600 and they paid $3000 towards the bill $1000 per month only.
      Please help

  2. Beth Nigro says:

    Hi there,
    I stated taking Ampyra a few months ago. I assumed I didn’t qualify for patient assistance too so I was paying $200/month though my private insurance from my job. I called Acorda and was told that the only requirement for patient assistance is having private insurance through your employer. I worked with Acorda and am now getting my Ampyra for $40/month. My specialty pharmacy also credited me back the $160 for each month prior that I paid the $200 co-pay. Wasn’t sure if you might also be able to get this price but wanted to share the info.

    • Ed Tobias says:

      Hi Beth,

      Thanks for sharing that info. I had the same $40 co-pay deal for Ampyra but, as you say, it’s attached to the requirement that you have private drug insurance coverage through your employer. The deal ended when I retired and went onto Medicare. Acorda told me that Medicare regulations prohibit that $40 co-pay assistance. They CAN, however, provide the drug FOR FREE, but only if the Medicare recipient’s income is below a certain level. How do they figure out these regulations?

      Ed

      • Carol says:

        They cut my husband off the program that paid his Ampyra. Accorda sent a letter out about the drug going generic. They would no longer be covering anyone on the assistance program that got their meds free.

        • Ed Tobias says:

          Carol,

          Yes, we’ve heard from others that the payment assistance for Ampyra ended when the generic became available. You can scroll down to the “comments” section to read some of those. I’ve also read some comments about people who use an affordable compound medication called 4-AP, which is similar to Ampyra. You might want to look into that.

          Ed

    • Rach says:

      Which you may now have found has changed since May the threshold has increased and no longer provide the $40 co pay since court cases

      I haven taking for a year at $40 co pay now they tell me it will be $1460 goodbye Ampyra

      • Ed Tobias says:

        Hi Rachel,

        I hadn’t heard about this. That’s really too bad. I found that Ampyra helped my walking. There needs to be a way to provide these drugs to people who need them but who can’t afford the high out-of-pocket cost. And, I’m afraid it’s only going to get worse here in the U.S., based upon the latest healthcare bills that Congress is working on.

        Ed

  3. León says:

    “Medical innovation depends on the recognition of valid intellectual property claims”

    The cure and life improvement depends on people who want to earn millions forever.

    Acorda is a good example of how the pharmaceutical industry work. I’m pretty sure I’ll never read the headline “Acorda finds the cure for MS”

  4. Josh Remus says:

    I’m surprised more people aren’t taking the generic, compounded version.
    I’d love to see a drug company release a generic Ampyra, since I’d prefer not to take it three times a day, but at $35 (obviously insurance doesn’t handle it) you can’t beat it!
    I’m not eligible for any of their copay assistance programs since I’m on Medicare.

  5. Paula says:

    I took the compounded version, made for me by compounding pharmacy before Ampyra became an “expensive ” drug. Cost was very low. After it became a drug my neurologist said he couldn’t write prescription for compounded version unless Ampyra didn’t work. Ampyra gives me ability to walk with a cane, helps my arms function better so I work full time. I can’t take night time dose due to feeling restless legs so I was thinking of asking neurologist if I could retry compounded version at night just to see the effect.

    • Ed Tobias says:

      Hi Paula,

      Thanks for that info. One or two other people have mentioned the compounded version but I’ve been reluctant to go that route because I have quality control concerns. In any event, I’m beginning to see some improvement in my walking that may be a result of my Lemtrada therapy, so I’ll see how that goes.

      Ed

  6. Andrea kaiser says:

    I took Ampyra for several years, it was a wonder drug for me. I defiantly knew if I missed a dose. I was paying about $30.00 a month. I stopped taking it because I had HSCT a year ago. I also started Medicare. I am no longer covered for it and it is over $500.00 a month. I call several co-assist foundations every week but there is no money:( I hope a generic will be approved.

    • Ed Tobias says:

      Hi Andrea,

      Thanks for taking the time to comment. I suspect that there are many folks with MS who were helped by Ampyra but who stopped using it because their drug insurance changed. Your experience mirrors mine.

      I hope your HSCT was successful for you.

      Ed

  7. Christine says:

    AMPYRA is the ONLY reason I was able to go back to work with Primary Progressive MS. I don’t want to think about not having it. It makes a huge difference for me. I’m one of the lucky ones. Glad there may be a generic. I could go mail order $12 For 3 month supply.

    • Ed Tobias says:

      I hear you, Christine. Ampyra worked very well for me, but it’s benefits didn’t outweigh its cost. My fingers are crossed that a generic will appear one of these days.

  8. Amy Thiessen says:

    Generic doesn’t always mean cheaper for the patient. Copaxone just went generic. It was purchased my Meylin (remember how much they started price gouging for Epi Pens last year?). For the patient, it means that there is little or no co-pay assistance, the in-home nurse trainers and support are gone, and the auto-injector devises many patients use require a separate prescription and authorization process. We are actually seeing an INCREASE in cost to the majority of patients. Generic doesn’t mean cheaper for the patient. It often just means a transfer money to another manufacturer.

  9. Marilee Chipoletti says:

    So now that Ampyra has lost its patent, how long before the generic hits the market? I’ve read that it might take anywhere from one to ten months. This is the only medication that keeps me walking, writing and speaking. I had lost all of these before starting this drug. If the generic does not hit the market soon, I will be nursing home bound in a few short months. HELP!

    • Ed Tobias says:

      Hi Marilee,

      I wish I could answer your question but I can’t. I did a quick on-line search to see if there’s been any action since I wrote my column last April. All I could find was that in June Acorda, which makes Ampyra, filed papers to oppose the challenge to its patent.

      Ampyra is certainly a drug with benefits. It’s a shame that, due to cost, it’s not available to more MS patients. Some drug companies offer payment assistance programs, but I’ve been unable to locate any information about whether Acorda has one. Some of the various MS associations may also be of help in providing, or locating, financial assistance.

      Ed

  10. Katie says:

    I went to fill my 3 month prescription of Ampyra last week and was told the cost would be $3,791.58. I also have been researching financial assistence. I was told to try to purchase it in Canada. Was curious if anyone had purchased theirs in another country.

    • wennett says:

      You can get aminopyridine at compound chemists..exactly same components. I use one in Queensland. Gooding chemist Gooding drive Merrimac have been using for 6 yrs and cost $79 for 120 tabs. Delivered. You don’t have to pay the drug company’s thousands of $
      My walking has improved heaps, no longer need a stick plus I take 1200 mg turmeric daily and dropped gluten and dairy.. haven’t looked back..hope this helps.

  11. Lance says:

    Hi Katie. It’s similar for our family. In 2018, Ampyra for my mother has moved up to $1200 a month AFTER the patient assistance program has been applied. Unfortunately its no longer affordable at nearly $15,000 a year.

  12. Carol says:

    My husband was kicked off the Ampyra Assistance program end of 2017. Ampyra said everyone on the program will get kicked off. As the drug goes generic in 2018. No one knows what date that will be. Or how much generic price will be. Right now on his insurance it’s to expensive. It could be 700$ a month.

  13. Barton says:

    I just noticed my mail order pharmacy is filling my new prescription for Ampyra with the generic – Dalfampridine. I recently spoke to a representative at Accorda and they led me to believe they’re making the generic as well. I’m starting Medicare in a few months and saw that the co-pay cost of Ampyra is enormous. I’m curious if the generic will make it much more affordable.

  14. Barton says:

    For a 3 month supply of Ampyra, my plan paid 7789.48. For a 3 month supply of the generic, it’s $4665.13. I don’t know what that means when I start on Medicare in a few months. I tried to price Dalfampridine on medicare.gov, but I couldn’t find it.

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