Dalfampridine ER Tablets, Generic Version of Ampyra, Now Available in US, Mylan Announces

Dalfampridine ER Tablets, Generic Version of Ampyra, Now Available in US, Mylan Announces

Mylan announced its U.S. launch of dalfampridine extended-release (ER) tablets, the authorized generic version of Acorda‘s Ampyra, that work to improve walking abilities in adults with multiple sclerosis (MS). Both versions of this medication come in a 10 mg tablet form.

Approved generic medicines are those that have been proven to be “bioequivalent” to their brand-name counterparts in terms of strength, dosage, quality, safety, and efficacy. Generics have the same active ingredients as brand-name medicines, and work in the same way. A major advantage is their cost-effectiveness: they are less expensive because their makers don’t face the same development costs as manufacturers of brand-name drugs.

Dalfampridine was approved in 2010 by the U.S. Food and Drug Administration (FDA) to improve walking abilities in patients with MS.

Data from clinical trials, including longer-term data, has shown that dalfampridine can significantly improve walking speed and distance, as well as gait and balance.

In particular, results of the Phase 3 clinical trial (NCT01328379) reported that the use of dalfampridine 10 mg “was associated with statistically significant and clinically meaningful improvements in walking relative to placebo” and that “the 10-mg BID [twice a day] dose is effective for improving walking speed, as observed on short timed-walk tests, and for increasing distance walked over longer timed-walk periods,” researchers wrote in a study reporting the findings.

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Both Ampyra and Mylan’s generic formulation block potassium channels on the surface of nerve fibers; this is thought to improve the conduction of signals along nerve fibers whose insulating myelin coating has been damaged by MS.

Side effects of the drug include shortness of breath or trouble breathing, swelling of throat or tongue, or hives.

The medication can cause seizures and should not be taken by people who have ever had a seizure, have certain types of kidney problems, or are allergic to dalfampridine, the active ingredient in Ampyra extended-release tablets and the dalfampridine ER tablets.

“The launch of Dalfampridine Extended-Release Tablets is yet another example of Mylan’s continued commitment to providing access for patients living with multiple sclerosis, and adds to our portfolio of products indicated for the disease or its related conditions,” Heather Breschs, Mylan CEO, said in a press release.

Dalfampridine generic launch in the U.S. was possible after the Court of Appeals for the Federal Circuit in September supported the decision of the U.S. District Court for the District of Delaware to invalidate four Ampyra patents held by Acorda.

Janet Stewart is a life sciences writer and editor, holds an MSc. in Virology and Immunology and has worked on research on multiple sclerosis during the course of her graduate studies.
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Janet Stewart is a life sciences writer and editor, holds an MSc. in Virology and Immunology and has worked on research on multiple sclerosis during the course of her graduate studies.
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26 comments

  1. Stephen Harris says:

    I used to take a compounded medication called 4-AP, intended to help with walking and gait. It was cheap and generic, and I had to order it from a small specialty compounding pharmacy. I had to pay for it myself, but the cost was minimal. Then along came Ampyra. It
    was the same thing but easier to obtain and more consistent. And vastly more expensive. And it replaced 4-AP. And now we’re sort of back to square one, with a generic version of Ampyra, which is what the original formulation known as 4-AP was. Generic or not, I will bet that delfampridine costs more than 4-AP did.

    • Leslie Willis says:

      I was on Ampyra a month after it was approved. Last January I went off it because of my insurance. A few months later, I went on 4-AP. It cost me $60.00 a month and did not help as much as Ampyra. A couple of months ago I received a letter from Ampyra saying that I might be able to go on Ampyra again. I found out I could, but where it used to cost $40.00 a month, it now was $60.00. I went back on, but I don’t see as much a benefit as I saw before. I’m hoping that it will start helping me more pretty soon.

      • mary varady says:

        Which compound pharmacy did you use for 4-AP? I’m interested because I can no longer afford my Ampyra but experienced several benefits. Thank you so much for sharing this info!

        • 4-AP is definitely not extended released, like Ampyra. So 4-AP may work differently for you. I use Koshland Compounding Pharmacy, 301 Folsom St, suite B, San Francisco, CA 94105 (415) 344-0600 for 4-AP for my downbeat nystagmus. (No MS). I take 4 per day of the 10mg capsules and they quoted me $170-$187 + about $10 shipping for 360 capsules which is a 3mos supply for me. They can not make extended release since it is commercially available as generic Dalfampridine ER.

      • Phyillis Brewer says:

        My dr sent in my script…when it was ready they called i ask the price..my Medicare RX would pay $1,100 and my cost was $900 a month
        I could not Afford that
        WHY DOES IT COST SO MUCH
        THIS IS CRAZY

        • Try googling Discount Pharmacy Coupons. Dalfampridine is the generic version of Ampyra, but it is not clear to me if Dalfampridine and Dalfampridine ER are the same thing (I think it is) Ampyra is definetly extended release. Some pharmacies have terrific discounts on the the generics if you download their coupons. I have not tried the coupons, yet, because I have always used the non ER (extended release) 4- aminopyridine and the Compounding Pharmacy will fill that Rx from my doctor for a huge discount, especially when I order a 3 mos supply. I pay cash and do not go through my insurance. If you need the extended release AND Dalfampridine ER IS the same as Dalfampridine you may be able to save a tremendous amount with a coupon. Watch for “small print” exception to some of the coupons. I found a coupon from Good Rx for $183.44 from Lucky Pharmacy for 60 tabs of Dalfampridine ER. However, the fine print said that the Rx must be written for the 60 tablets to be for 34 days which leaves you short for 4 days.

    • Mary says:

      Would you please share the name of the compounding pharmacy you used to get your 4-AP? I’m very interested in trying this since I can no longer afford Ampyra. Thank you!

      • ON 1-9-19: Koshland Compounding Pharmacy , 301 Folsom St, suite b, San Francisco, CA, 94105 phone # 415-344-0600 quoted me about $177 for 360 capsules of 10mg each of 4-AP + about $10 mailing fee to my home. Bear in mind that I have not been diagnosed with MS but my Neuro-ophthalmologist at Stanford Hospital sees me for downbeat nystagmus and wrote my 4-AP prescription for 4 capsules per day. Koshland had already received her Rx and I knew that they would probably discount a 3 mos supply since I take it 4 times a day. If you take it 2 times a day it would be a 6 mos supply for you. I pay cash and it does not go through my insurance. Remember that this is NOT the EXTENDED RELEASE formula. ALSO, I found a coupon through Good Rx for Dalfampridine ER for $153.29 for 60 tablets at Lucky Pharmacy. I have not followed up on this offer because it is unclear whether the ER would make a difference for me, so I don’t know if I can actually fill it and get this discount since I do not have a MS diagnosis. I hope this helps; I’ll try to watch this site in case you have other questions. I am also 69 years old and am on Medicare which a lot of time excludes me from trial discounts so that is another reason I don’t know if the Lucky coupon will work; the coupon does NOT say anything about a trial offer, so you maybe able to use every month????

    • Yes, I think you are right! Is the generic dalfampridine an extended release formula? I can’t seem to confirm that. Ampryra is definitely extended release. The 4-AP is definitely NOT extended release but if it worked for you the compounding pharmacy can still make it at a very low cost. Check it out with your local compounding pharmacy. If you order a 3 months supply you may be able to get a further discount per pill, as well.

      • Ron says:

        According to the above announcement, it is extended release. It would have to be inorder to have been approved as equivalent to Ampyra.

  2. I have had ms for 23 years and am a walking poster child for faith and exercising and eating,

    Went off all dugs years ago while planning to change to sim thing else,. But piickrd you thhe book when the brain changes itself and it reworked my brain. Still can’t run but feel pretty good and blessed but time to get back on something.

    Need recommendations

    • Khushnoor says:

      There are so many new oral medications available now, hopefully your neurologist is the best person to advise you on what will work best for you. I’m keen to know which book you are talking about. I would like to read it. Please send me the name and author.
      I would also like to recommend you read ::::The Mind Body Prescription by John Sarno.
      Very interesting book!

      Good luck with everything!

  3. Eve C says:

    Was taking ampyra and getting payment assistance through drug company,at that time the drug was working well. Went on medicare lost my assistance now have to pay 946.00 can’t afford, looking forward to generic.

      • Try googling discount coupons for RX. Caution: read the fine print- that said, You should be able to find a discount dalfampridine coupon at various pharmacies for a tremendous discount. I believe Dalfampridine is extended release but I am not positive. I say read the fine print because the cheapest coupon I found for dalfampridine ER was at the Lucky Pharmacy (super market pharmacy here in CA) for $183.44 for 60 tabs but only if the Rx was written for 34 days. That leaves you 4 days short. If you can take a non extended release then you can get 4-aminopyridine made by a compounding pharmacy for much less. I take the 4-AP for downbeat nystagmus (not MS) and it helps my eye movement tremendously and therefore helps my balance. Research shows that 4-AP definitely helps downbeat nystagmus but I haven’t googled research on 4-AP for MS. Check with your doctor, for sure, because I know that Ampyra and generic Dalfampridine were developed specifically for MS!

  4. John Pierce says:

    In our system where profits are the main product, and health care is only a by-product, they can charage anything they want.

  5. Daryl says:

    I was on Ampyra for years with no problems when the mail order drug company changed me to Dalfampridine generic last week Imhave had a headache since so I have missed a day and headache is gone I have called everyone I can They are sending me some new meds tomorrow.

  6. Rebecca Wallace says:

    I was forced by my health insurance company to switch to the generic Dalfampridine er 10mg tb12. Things did not go well. Fortunately, I had a friend (who’s an RN) was visiting during this period. After about 3 days I noticed something was different, the new generic was not functioning as well as Ampyra. She asked me if I had changed any medication, as she had noticed a decline in my balance and changes in my gait. I explained the change in medication. Fortunately I found 4 days worth of Ampyra, so we did a “study”. I waited 24-hours after my last Dalfampridine er 10mg tb12 tablet, then took an Ampyra. For the next 4 days I took my Ampyra as normal (one every 12 hours). It was remarkable! My balance and gait improved. So generics are not all they are cracked up to be.

  7. Clint says:

    The generic price was high for the first 6 months due to FDA regulations, but should have come down after that. Of more concern is the lack of quality in generics from India and China. Read the book “Bottle of Lies” by Katherine Eban – found it at the local library. Dalfampridine from Mylan is from India, but there is a second generic source that I am looking into.

  8. Ed says:

    Now that we are almost a year into this debacle it has become clear that the only generic that has been working is the Mylan brand. Come to find out, it’s manufactured at the same factory in Ireland as the Ampyra brand.
    A great compounding pharmacy for 4-AP is Belmar Pharmacy.

    http://www.belmarpharmacy.com

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