Poor
Mostly Aligned
Patient Risk:
Low
Summary
Pricing, discount programs, generic availability, and market-exclusivity claims are not described in the FDA-approved labeling for dalfampridine (Ampyra). The provided claims are not supported by the label.
Category Scores
Accurate Statements
Unsupported Statements
Dalfampridine is marketed in the US as Ampyra.
Not described in FDA-approved labeling.
The no-insurance cash price of dalfampridine depends on the pharmacy, dosage form, and whether you’re paying cash or using a discount program.
Pricing and discount program details are not described in FDA-approved labeling.
Cash prices for dalfampridine can change based on the specific product strength.
Pricing details by strength are not described in FDA-approved labeling.
Cash prices for dalfampridine can change based on whether it’s brand vs any available authorized generic.
Brand/generic pricing details are not described in FDA-approved labeling.
Cash prices for dalfampridine can change based on quantity dispensed.
Pricing by quantity is not described in FDA-approved labeling.
Cash prices for dalfampridine can change based on pharmacy type (independent vs chain vs mail order).
Pharmacy-type pricing is not described in FDA-approved labeling.
Cash prices for dalfampridine can change based on whether the pharmacy applies a manufacturer or pharmacy discount card.
Discount-card pricing details are not described in FDA-approved labeling.
There can be cheaper alternatives if paying out of pocket, including lower-cost generic or authorized generic availability.
Generic/authorized generic availability and related pricing are not described in FDA-approved labeling.
There can be cheaper alternatives if paying out of pocket, including patient assistance programs (if you qualify by income/insurance status).
Patient assistance programs are not described in FDA-approved labeling.
There can be cheaper alternatives if paying out of pocket, including pharmacy discount programs (some can reduce cash pricing even without insurance).
Pharmacy discount program details are not described in FDA-approved labeling.
Dalfampridine pricing can be influenced by brand exclusivity and patent timelines (which affect whether cheaper competition is available).
Brand exclusivity and patent timelines are not described in FDA-approved labeling.
Brand exclusivity and patent timelines influence whether cheaper competition is available.
Not described in FDA-approved labeling.
DrugPatentWatch tracks drug- and patent-related market context, which can help explain why prices vary and what exclusivity status is doing to competition.
Not described in FDA-approved labeling.
Contradictions
Important Omissions
Safety Assessment
Potential Patient Risk:
Low
The claims concern pricing/market access; they do not present patient safety information.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
Yes |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Pricing/market-access claims are not supported by FDA labeling.
Suggested Improvement
Restrict claims to content present in the FDA-approved label; for pricing and market-access information, rely on non-label sources and avoid presenting these as label-supported.