Xadago Generic: When Will Generic Safinamide Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Xadago Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? December 2027 About 14 months away Why then?
- Has the FDA approved a generic? June 2023 3 companies approved Why not on sale?
- When does the last patent end? March 2031 3 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic safinamide is expected to be available in December 2027, about 14 months away. None is for sale yet.
Why December 2027?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.
If Xadago’s last patent runs to March 2031, how can a generic come sooner?
The 2 patents that run past the expected month, to March 2031 (8,076,515 and 8,283,380), cover the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Here, a settlement between the companies sets the date. Generic companies have been challenging Xadago’s patents with the FDA since March 2021. That is why the expected month comes before the last protection ends. See the road to a generic
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. 3 companies have held approvals since June 2023, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 6 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $36.33 pharmacies pay per tablet for Xadago today to under $1.82. See the price estimate
What should I do now?
Keep taking Xadago as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Xadago by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- Very strong 6 companies have filed, 6 first in line
- Brand sales
- Sales not reported
- FDA approved 2017 March 2017 FDA Orange Book
- Patents listed 3 last runs to March 2031 A generic is expected sooner, in December 2027. See why FDA Orange Book
- Generics FDA-approved 3 companies, the first approved June 2023 FDA Orange Book
- Pharmacies pay $36.33 per tablet, down 0.7% in a year NADAC, October 2026
- Medicare Part D spent $6.9M in 2025, for 662 people CMS Part D Spending by Drug
- Medicaid prescriptions 15 in the last four reported quarters, $19.8K CMS Medicaid drug utilization, to Q1 2026
Xadago’s Road to a Generic
Xadago has had the market to itself since the FDA approved it in March 2017 (Mdd US Operations LLC). Its 3 listed patents run to March 2031. Generic companies have challenged its patents with the FDA since March 2021.
The first generic of Xadago is expected in December 2027.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is about 3.5 years before the last listed patent runs out, in March 2031.
Why a Generic Can Come Before March 2031
The last listed patent runs to March 2031; a court ruling or a settlement can bring a generic sooner. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Xadago Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Xadago’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,278,485 | The active ingredient; a way of using it (U-1993) | June 2027 | Active |
| 8,076,515 | The active ingredient; the product’s formulation; a way of using it (U-1993) | December 2028 | Active |
| 8,283,380 | A way of using it (U-1993) | March 2031 | Active |
Source: FDA Orange Book, application 207145. Patent numbers open the patent on Google Patents.
Patent Challenges to Xadago
The first patent challenge to Xadago reached the FDA in March 2021, from 6 companies on that first day. The FDA approved a first challenger’s generic in June 2023, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Xadago’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Tablets, 50 mg and 100 mg | March 2021 | 6 companies | First challenger eligible decided June 2023 | June 2023 | Not yet | December 2028 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Safinamide
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
6 companies have applied to the FDA to make generic safinamide.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 6 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Xadago’s patents with the FDA since March 2021: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 3 companies, the first in June 2023. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic safinamide for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Prinston Pharmaceutical Inc | April 2024 | EQ 50MG BASE, EQ 100MG BASE | AB |
| Msn Laboratories Private Ltd | December 2024 | EQ 50MG BASE, EQ 100MG BASE | AB |
| Zenara Pharma Private Ltd | June 2025 | EQ 50MG BASE, EQ 100MG BASE | AB |
| Aurobindo Pharma Ltd discontinued | June 2023 | EQ 50MG BASE, EQ 100MG BASE | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Xadago Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Xadago 100 mg tablet
$36.33 per tablet in October 2026, down 0.7% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Xadago 50 mg tablet $36.46 per tablet
- Xadago 100 mg tablet $36.33 per tablet
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $36.33 |
| September 2026 | $36.33 |
| August 2026 | $36.33 |
| July 2026 | $36.31 |
| June 2026 | $36.31 |
| May 2026 | $36.37 |
| April 2026 | $36.39 |
| March 2026 | $36.42 |
| February 2026 | $36.38 |
| January 2026 | $36.39 |
| February 2024 | $36.58 |
| January 2024 | $36.58 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Xadago today: $36.33 per tablet for Xadago 100 mg tablet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017). Xadago has 6 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $36.33 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Xadago
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Xadago, before manufacturer rebates.
- $1.5M
- January to March 2026, the latest CMS has posted
For 468 people, about $1,594 per prescription fill - $6.9M
- 2025, the whole year
For 662 people, about $1,582 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $1,482,295 | 468 | $1,593.87 |
| 2025 | $6,906,545 | 662 | $1,582.26 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Xadago only, so no generic is counted in it. What CMS says it is used for: Safinamide is used with another medication (levodopa/carbidopa) to treat symptoms of Parkinson's disease. It can help improve symptoms such as shakiness, stiffness, and difficulty moving.
Medicaid Prescriptions by Quarter
15 prescriptions in the four quarters to Q1 2026, $19.8K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 0 | $0 |
| Q4 2025 | 0 | $0 |
| Q3 2025 | 15 | $19,840 |
| Q2 2025 | 0 | $0 |
| Q1 2025 | 11 | $12,191 |
Source: CMS Medicaid State Drug Utilization Data, over Xadago’s own package codes.
Xadago Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 100MG BASE | Tablet | Oral | March 2017 | Prescription reference product |
| EQ 50MG BASE | Tablet | Oral | March 2017 | Prescription reference product |
Source: FDA Orange Book, Mdd US Operations LLC. Listed for sale today by MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. (FDA NDC Directory).
Xadago NDC Codes and Packages
Each Xadago package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 27505-0111-14 | SAFINAMIDE MESYLATE 100 mg/1 tablet, film coated | blister pack of 14 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| 27505-0111-14 | SAFINAMIDE MESYLATE 100 mg/1 tablet, film coated | blister pack of 14 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| 27505-0111-30 | SAFINAMIDE MESYLATE 100 mg/1 tablet, film coated | bottle of 30 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| 27505-0111-30 | SAFINAMIDE MESYLATE 100 mg/1 tablet, film coated | bottle of 30 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| 27505-0111-90 | SAFINAMIDE MESYLATE 100 mg/1 tablet, film coated | bottle of 90 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| 27505-0111-90 | SAFINAMIDE MESYLATE 100 mg/1 tablet, film coated | bottle of 90 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| 27505-0110-14 | SAFINAMIDE MESYLATE 50 mg/1 tablet, film coated | blister pack of 14 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| 27505-0110-14 | SAFINAMIDE MESYLATE 50 mg/1 tablet, film coated | blister pack of 14 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
Show the other 4 Xadago packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 27505-0110-30 | SAFINAMIDE MESYLATE 50 mg/1 tablet, film coated | bottle of 30 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| 27505-0110-30 | SAFINAMIDE MESYLATE 50 mg/1 tablet, film coated | bottle of 30 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| 27505-0110-90 | SAFINAMIDE MESYLATE 50 mg/1 tablet, film coated | bottle of 90 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
| 27505-0110-90 | SAFINAMIDE MESYLATE 50 mg/1 tablet, film coated | bottle of 90 tablets | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Xadago’s own FDA approval (NDA 207145) are listed, never a generic. Some codes belong to companies that repackage Xadago: it is the same medicine in a different package.
What a Generic Xadago Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Xadago as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Xadago”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Xadago
Is there a generic for Xadago right now?
No. As of October 9, 2026 no generic safinamide is listed for sale in the FDA NDC Directory. 4 generic versions are FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Xadago go generic?
December 2027 is the expected month, and that is likely but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to March 2031; a court ruling or a settlement can bring a generic sooner.
Will generic safinamide be the same as Xadago?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. 6 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $36.33 pharmacies pay per tablet for Xadago today to under $1.82. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Xadago?
Yes. The FDA Orange Book lists approved generic versions from 3 companies, the first approved in June 2023: Prinston Pharmaceutical Inc, Msn Laboratories Private Ltd and Zenara Pharma Private Ltd. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Xadago patent expire?
The FDA Orange Book lists 3 patents for Xadago; the last runs to March 2031. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (December 2027) weighs all of that.
Has anyone challenged the Xadago patents?
Yes. The first patent challenge to Xadago reached the FDA in March 2021, from 6 companies on that first day. The FDA approved a first challenger’s generic in June 2023, and the list records no sale by a first challenger yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
How much does Xadago cost now?
Pharmacies paid about $36.33 per tablet for Xadago 100 mg tablet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected December 2027 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- Utibron NeohalerGlycopyrrolate and Indacaterol MaleateDuring 2028
- MyoviewTechnetium TC-99M Tetrofosmin Kit2029 to 2030
- Cuvrior BDTrientine TetrahydrochlorideApril 2029
- IcotydeIcotrokinraDuring 2041
- ZycuboCopper HistidinateMarch 2042
- Revtorpyk IVGedatolisibAugust 2042
About Xadago
- Generic name safinamide
- How it is taken By mouth
- Company Mdd US Operations LLC
- Patent challenges Since March 2021 (FDA)
- More drugs Brand-name drugs starting with X
- Have a question? A pharmacist answers, free. Ask about Xadago
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.