A Generic for Ampyra Could Be Released Soon

Ed Tobias avatar

by Ed Tobias |

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Editor’s note: Shortly after this column was published, Mylan pharmaceuticals announced it will begin distributing Dalfampridine Extended-Release Tablets, 10 mg, the authorized generic version of Acorda’s Ampyra. There’s been no word, yet, on what it will cost or how soon the generic will become available in pharmacies.

A few years ago, I had to give up using Ampyra (dalfampridine), the MS medication that can improve walking speed. Though I felt that the medication did slightly improve my speed, a change in insurance made its out-of-pocket costs excessive for me.

But now, thanks to a court ruling, we may be closer to the day when a generic version of Ampyra is available. Presumably, that generic would be more affordable. A few days ago a U.S. Court of Appeals upheld a lower court ruling that had invalidated four key patents held by Ampyra’s manufacturer, Acorda Therapeutics. Those patents have to do with the methods used to deliver the medication to a patient, and the court ruled that Acorda’s methods weren’t unique enough to warrant a patent. (A fifth patent expired a couple of months ago).

Will Acorda give up its Ampyra patent fight?

In a news release issued after the ruling, Acorda, apparently trying to reassure investors, writes: “Following the Court’s original decision in 2017, we prepared a contingency plan [so] that we could face generic competition, implementing a comprehensive corporate restructuring and bolstering our balance sheet.”

Though Acorda CEO Dr. Ron Cohen says the company is considering a further appeal, the fact that Acorda has put a plan in place to “face generic competition” gives me hope that the company won’t go back into court.

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Generic Ampyra appears ready to roll

At the time of the original lawsuit, in 2017, 10 rival pharmaceutical companies hoped to market a generic Ampyra. The Food and Drug Administration has already approved applications submitted by generic manufacturers Actavis Generics (acquired by Teva Pharmaceutical Industries, Ltd.) and Aurobindo Pharma Limited.

According to Investor’s Business Daily, a market analyst named Ken Trbovich went as far as to note, “… we expect nearly immediate launch of generic competition that will rapidly capture more than 90% of Acorda’s Ampyra prescription volume and lead to the loss of nearly all of Ampyra’s revenues over the coming months.”

I’m sure I’m not alone in hoping that a generic Ampyra will be available at a reasonable cost. Let’s hope this happens quickly, as Trbovich predicts. I’m ready to ask for a new prescription as soon as it does.

You’re invited to follow my personal blog at www.themswire.com.

***

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.

Comments

Patsy Sipes avatar

Patsy Sipes

Please let me know as soon as you can. I have appointment with my MS doctor Sept 21 in Dallas.I can't wait to hear from you.

Reply
Ed Tobias avatar

Ed Tobias

Hi Patsy,

Please keep an eye here on Multiple Sclerosis News Today. I'm sure we'll report when one of the pharmaceutical companies mentioned in my column begins to distribute the generic form.

Ed

Reply
Rick avatar

Rick

Thank goodness.

Reply
Ed avatar

Ed

Unfortunately, the courts reversed those decisions and we will not be seeing a generic Ampyra anytime soon.

https://www.biopharmadive.com/news/acorda-gets-reprieve-as-ampyra-generic-is-delayed/529418/

Reply
Ed Tobias avatar

Ed Tobias

Ed,

It's your information, from the link you attached to an August article, that is outdated. About a week ago a Court of Appeals upheld a lower court's decision that invalidated four Ampyra patents. (A fifth patent, which the lower court had upheld, expired in July).

Please read two items regarding that appeals court decision, both of which I referenced and linked to in my column.

Acorda company news release: https://www.businesswire.com/news/home/20180910005687/en/U.S.-Court-Appeals-Federal-Circuit-Upholds-District

Investors Business Daily: https://www.investors.com/news/technology/acorda-therapeutics-amypra-patent-multiple-sclerosis/

Ed

Reply
cynf avatar

cynf

Yay, this has been tricky to follow with the court reversals.

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Patsy Sipes avatar

Patsy Sipes

It went great.

Reply
RocksGirl avatar

RocksGirl

Ampyra has an outstanding co pay program and only costs me $10 per month. I’m concerned that a generic will cost me more!

Reply
Ed Tobias avatar

Ed Tobias

Yes, it does. I was a recipient of it when I was still working and using commercial medical insurance. Once I went on Medicare their co-pay program was no longer available to me.

Let's hope that the the generic doesn't wind up costing you more, or that Acorda doesn't drop that co-pay program.

Ed

Reply
Patsy Sipes avatar

Patsy Sipes

Ed I hope your you are ok. Let me know when you hear anything about Ampyra!! I would like to get everyone would like write or call US COURTS. IF THEY HAD MS THEY PAST IT.

Reply
Deborah Martens avatar

Deborah Martens

Ampyra went generic in the U.S. as of 1/1/2018. You can obtain the generic through College Pharmacy (a compounder) for $350 for a three month supply.

Collegepharmacy.com
800-888-9538

Reply
Ed Tobias avatar

Ed Tobias

Thanks for that info, Deborah.

Ed

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Samuel Devasagayam avatar

Samuel Devasagayam

Is there any tests to confirm the dicease is MS?

Reply
Winters Cindy avatar

Winters Cindy

Ampyra was being used cheaply for years. It had another name back then—4 amino pyradine. Acorda made an extended release version, renamed it, and tucked their new patent in their wallet. The immediate release 4 amino pyradine can be compounded at any compounding pharmacy for a fraction of the cost. Unfortunately, this information is not widely dissimenated—not here, not by various MS groups, nor by our docs! Who should we turn to?

Reply
Ed Tobias avatar

Ed Tobias

Thanks for allowing us to turn to you, Cindy, for this information. (And to others who have shared similar info in these comments).

Ed

Reply
Marie avatar

Marie

I was told today by my commercial health insurer's Rx provider that Accorda just started to manufacture a generic Ampyra (dalfampridine) that will be distributed by Mylan. The next time my prescription is filled, it will be with this generic version.

Reply
Ed Tobias avatar

Ed Tobias

That's right, Mary. Thanks for sharing the info.

I've been trying to get an idea from the marketing people at Mylan of what the cost of their generic will be compared to the brand name medication but, so far, I've been unsuccessful. I'd appreciate it if you'd let us know if changing to the generic affects your out-of-pocket cost for the med.

Thanks,

Ed

Reply
Kimberly Thomas avatar

Kimberly Thomas

Found out that I will be getting the generic, Dalfampridine, next month...
Googled pricing and wellrx.com/perscriptions
In Huntsville AL, the generic is about the same as Ampyra itself,
180 day of both-
Ampyra $7986-$9016
Dalfampridine $6105-$7668

I Praise my Lord Jesus, that I found a list of co-pay assistance companies which I've been using since I started MS meds in 1995, and have had $0 copays on both Ampyra and Gilenya for over 6 years now, as well as all the prior shot therapies I've had... Thank You, Lord!!

Reply
Nedo avatar

Nedo

I got a prescription for 4AP from a compounding pharmacy in 08 and went on Ampyra in 2010 and I could have stayed on it for about $50 per 1 or more month script.

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Jeff avatar

Jeff

Which compounder?

Reply
dooner avatar

dooner

It should be noted that some insurance companies have already started to remove Ampyra from their approved drug lists and are insisting on the generic version for coverage of future refills.

If you are on Ampyra, check your coverage before your next refill.

Reply
Ed Tobias avatar

Ed Tobias

Good point. I've seen reports of this on several MS Facebook groups.

It appears that having the generic will make Ampyra affordable for me under my Medicare Part D plan.

Ed

Reply
KENDRA RAE PARSON avatar

KENDRA RAE PARSON

FYI
There are programs out there that will help w/ insurance copays. IDK about all of them, but the one I use is for government insurance i.e.: medicare (& maybe medicaid to); it's called, The Assistance Fund, for more information, go to https://tafcares.org/
I hope this helps some of you.

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