Skip to content

Is there a generic version of Ampyra?: Your guide to dalfampridine

3 min read

According to the National Multiple Sclerosis Society, Ampyra (dalfampridine) is a widely used oral medication to improve walking ability in people with MS. A major development for patients came after 2018, when multiple generic versions of Ampyra became available in the United States. This offers a more affordable alternative for individuals managing the condition.

Quick Summary

Generic dalfampridine extended-release tablets are available as a more affordable equivalent to the brand-name drug Ampyra. It is used to improve walking in adults with multiple sclerosis by blocking potassium channels in damaged nerve fibers. Approval by the FDA occurred after patent expiration and litigation, paving the way for numerous manufacturers to enter the market.

Key Points

  • Generic Availability: Generic dalfampridine extended-release tablets, the equivalent of Ampyra, have been available in the U.S. since 2018.

  • Significant Cost Savings: Generic versions are much more affordable than brand-name Ampyra, with some versions potentially saving patients hundreds or thousands of dollars monthly.

  • Therapeutic Equivalence: The FDA has certified that generic dalfampridine is therapeutically equivalent to Ampyra, meaning it has the same active ingredient, strength, and effect.

  • Potassium Channel Blocker: Dalfampridine works by blocking potassium channels in damaged nerve fibers to improve electrical signal conduction and walking speed in MS patients.

  • Risk of Seizures: A serious potential side effect is seizures, and the medication is contraindicated for those with a history of seizures or kidney problems.

  • Same Side Effect Profile: The generic version carries the same side effect profile as Ampyra, including common issues like UTIs, insomnia, dizziness, and headache.

  • Not a DMT: Generic dalfampridine is a symptomatic treatment for walking impairment and is not a disease-modifying therapy for MS.

In This Article

Yes, a generic version of Ampyra is widely available

Yes, there is a generic version of Ampyra (dalfampridine extended-release tablets). The first generic formulations were launched in the United States following the invalidation of several of Ampyra's patents in 2018. The generic equivalent, also known as dalfampridine, is available from multiple manufacturers. This availability has made the medication significantly more affordable for many patients with multiple sclerosis (MS) who use it to help improve their walking ability.

How generic dalfampridine works

Both the brand-name Ampyra and its generic versions contain the active ingredient dalfampridine. The medication is a potassium channel blocker. In MS, damage to the protective myelin sheath covering nerve fibers can disrupt the normal transmission of electrical signals. By blocking certain potassium channels on these damaged nerve fibers, dalfampridine is thought to restore proper nerve signal conduction. The result can be improved walking speed and mobility for some MS patients.

Key benefits of generic dalfampridine

  • Significant cost savings: Generic medications are typically much less expensive than their brand-name counterparts. In fact, recent low-cost generic launches have been highlighted for saving patients nearly $1,000 per month compared to other generic options. This cost reduction is a major benefit for those who require long-term treatment.
  • Improved access: The lower price point can make the medication accessible to more patients, including those with limited insurance coverage or high out-of-pocket costs.
  • Therapeutic equivalence: The U.S. Food and Drug Administration (FDA) requires that generic drugs be therapeutically equivalent to their brand-name counterparts. This means they must contain the same active ingredient, be identical in strength, dosage form, and route of administration, and be absorbed into the body at the same rate and to the same extent.

Ampyra vs. generic dalfampridine: A comparison

Feature Brand-Name Ampyra Generic Dalfampridine
Active Ingredient Dalfampridine Dalfampridine
Mechanism of Action Potassium channel blocker Potassium channel blocker
Indication Improves walking in adults with MS Improves walking in adults with MS
FDA Approval Approved in 2010 First generics approved in 2018
Cost Significantly higher Much lower, especially with competition
Appearance May differ (shape, color) May differ from brand and other generics
Effectiveness Bioequivalent; same therapeutic effect Bioequivalent; same therapeutic effect

Considerations and potential side effects

When switching from brand-name Ampyra to generic dalfampridine, it's important for patients to discuss the transition with their healthcare provider. The safety profile of the generic is the same as the brand name.

Serious side effects

  • Seizures: Dalfampridine can cause seizures, even in individuals with no prior history. The risk is higher with excessive dosing or reduced kidney function.
  • Allergic reactions: Severe allergic reactions, including anaphylaxis, can occur.

Common side effects

  • Urinary tract infections (UTIs)
  • Insomnia (trouble sleeping)
  • Dizziness
  • Headache
  • Nausea
  • Weakness
  • Back pain

Contraindications Patients should not take dalfampridine if they have a history of seizures or moderate to severe kidney impairment.

The role of generic dalfampridine in MS treatment

Generic dalfampridine is an important medication for symptom management, but it is not a disease-modifying therapy (DMT) and does not treat the underlying causes of MS. It is often used in conjunction with other MS treatments to help improve mobility and quality of life. For example, the National Multiple Sclerosis Society provides resources on various medications and devices for managing MS-related walking difficulties.

Conclusion

The availability of a generic version of Ampyra, dalfampridine extended-release tablets, represents a significant victory for patient access and affordability. Multiple manufacturers have received FDA approval, leading to increased competition and lower costs. While the therapeutic effects are identical to the brand-name drug, patients must be aware of the same potential side effects and contraindications. Consulting a healthcare provider is essential when considering a switch to ensure proper dosage, monitor for side effects, and verify the generic is appropriate for your specific health needs.

Frequently Asked Questions

The generic name for Ampyra is dalfampridine extended-release tablets.

Yes, generic dalfampridine is considered therapeutically equivalent to Ampyra by the FDA. It contains the same active ingredient and is expected to have the same effect on improving walking in MS patients.

The first generic formulations of dalfampridine became available in the United States starting in September 2018, after patent litigation allowed multiple manufacturers to launch their products.

Yes, several manufacturers produce generic dalfampridine, including Mylan (now Viatris), Hikma, Actavis, Aurobindo, and Civicascript.

Generic dalfampridine is significantly cheaper than brand-name Ampyra. Specific prices vary, but some reports show monthly savings potentially nearing $1,000 or more, especially with more recent low-cost generic entrants.

Patients should not take generic dalfampridine if they have a history of seizures or have moderate to severe kidney impairment.

You should speak with your doctor or pharmacist about switching to generic dalfampridine. Your doctor will need to provide a new prescription for the generic version.

Most insurance plans cover generic dalfampridine. Some may even require a trial of the generic version before they will cover the more expensive brand-name Ampyra.

References

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10

Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.