Prescription medicine
Safinamide Brand names: Xadago
Safinamide (Xadago) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $36.33 per Xadago 100 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: safinamide labels on DailyMed; the NDA 207145 record on Drugs@FDA; every safinamide label on DailyMed.
Highlights of the record
no current FDA label; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 50 mg
- 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 21, 2017 Xadago, Mdd Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first June 14, 2023; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 21, 2031 Xadago tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $36.33 per tablet Xadago 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
Is there a generic for safinamide (Xadago)?
The FDA approved the first generic safinamide on June 14, 2023. 4 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 3 patents for Xadago tablets: the compound patent runs to December 10, 2028, and the last listed entry to March 21, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2023 first generic approved
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for safinamide (Xadago)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $36.33 per Xadago 100 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Xadago 100 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Xadago 100 mg tablet | Brand | $36.33 per tablet | $1,089.77 | -0.4% |
| Xadago 50 mg tablet | Brand | $36.46 per tablet | $1,093.77 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What next?
- Alternatives to safinamide
- medicines labeled for the same conditions
- Other monoamine oxidase type b inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other