Xywav Generic: When Will It 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
Xywav Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? During 2033 Sometime that year Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? February 2041 16 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 calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate is expected to be available sometime in 2033. None is for sale yet.
Why 2033?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.
If Xywav’s last patent runs to February 2041, how can a generic come sooner?
The 3 patents that run past the expected month, to February 2041 (11,426,373, 12,138,233 and 12,582,622), cover a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, the companies are expected to settle on a date. Generic companies have been challenging Xywav’s patents with the FDA since April 2021. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, and more so as more companies sell one. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. See the price pattern
What should I do now?
Keep taking Xywav 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.
Xywav by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- Moderate 3 companies have filed, 1 first in line
- Brand sales
- $2.8B a yearBlockbuster
- FDA approved 2020 July 2020 FDA Orange Book
- Patents listed 16 last runs to February 2041 A generic is expected sooner, sometime in 2033. See why FDA Orange Book
- Medicare Part D spent $249.7M in 2025, for 1,710 people CMS Part D Spending by Drug
- Medicaid prescriptions 9,264 in the last four reported quarters, $155M CMS Medicaid drug utilization, to Q1 2026
Xywav’s Road to a Generic
Xywav has had the market to itself since the FDA approved it in July 2020 (Jazz Pharmaceuticals Ireland Ltd). Its FDA protection (orphan drug) runs to August 2028. Its 16 listed patents run to February 2041. Generic companies have challenged its patents with the FDA since April 2021.
The first generic of Xywav is expected sometime in 2033.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before February 2041
The last listed patent runs to February 2041, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge. 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.
Xywav Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Xywav’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 |
|---|---|---|---|
| 8,591,922 | The product’s formulation | January 2033 | Active |
| 8,901,173 | The product’s formulation | January 2033 | Active |
| 9,132,107 | The product’s formulation | January 2033 | Active |
| 10,195,168 | The product’s formulation | January 2033 | Active |
| 10,675,258 | A way of using it (U-2938) | January 2033 | Active |
| 11,554,102 | The product’s formulation | January 2033 | Active |
| 11,986,446 | A way of using it (U-3017, U-3324) | March 2033 | Active |
| 8,772,306 | A way of using it (U-3198, U-1532) | September 2033 with the pediatric extension | Active |
| 9,050,302 | A way of using it (U-1532) | September 2033 with the pediatric extension | Active |
| 9,486,426 | A way of using it (U-1532) | September 2033 with the pediatric extension | Active |
| 10,213,400 | A way of using it (U-2499) | September 2033 with the pediatric extension | Active |
| 10,864,181 | A way of using it (U-3017) | September 2033 with the pediatric extension | Active |
| 11,253,494 | A way of using it (U-3323, U-3324) | September 2033 with the pediatric extension | Active |
| 11,426,373 | A way of using it (U-3432) | September 2037 | Active |
| 12,138,233 | A way of using it (U-4044) | February 2041 | Active |
| 12,582,622 | A way of using it (U-4044) | February 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-361 | Seven years of protection for a use in a rare disease. | July 2027 | Active |
| Pediatric PED | Six more months, earned by studying the medicine in children. | January 2028 | Active |
| Orphan drug ODE-369 | Seven years of protection for a use in a rare disease. | August 2028 | Active |
Source: FDA Orange Book, application 212690. Patent numbers open the patent on Google Patents.
Patent Challenges to Xywav
The first patent challenge to Xywav reached the FDA in April 2021, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Xywav’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 | |||||
| Oral solution, 0.234 g/0.096 g/013 g/0.04 g per mL | April 2021 | 1 company | No decision yet | Not yet | Not yet | March 2033 |
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 Calcium Oxybate, Magnesium Oxybate, Potassium Oxybate, and Sodium Oxybate
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
3 companies have applied to the FDA to make generic calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Xywav’s patents with the FDA since April 2021: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate for sale with the FDA.
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).
Xywav Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Xywav, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay 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).
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 Xywav
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 Xywav, before manufacturer rebates.
- $65.4M
- January to March 2026, the latest CMS has posted
For 1,403 people, about $18,252 per prescription fill - $249.7M
- 2025, the whole year
For 1,710 people, about $17,577 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $65,431,748 | 1,403 | $18,251.53 |
| 2025 | $249,660,581 | 1,710 | $17,576.78 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Xywav only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat narcolepsy, a condition that causes severe daytime sleepiness. It can decrease daytime sleepiness and also reduce the number of sudden short attacks of weak/paralyzed muscles (known as cataplexy) that can occur in patients with narcolepsy.
Medicaid Prescriptions by Quarter
9,264 prescriptions in the four quarters to Q1 2026, $155M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 2,128 | $36,427,486 |
| Q4 2025 | 2,405 | $40,040,145 |
| Q3 2025 | 2,393 | $39,886,726 |
| Q2 2025 | 2,338 | $38,655,618 |
| Q1 2025 | 2,201 | $35,848,964 |
Source: CMS Medicaid State Drug Utilization Data, over Xywav’s own package codes.
Xywav Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | Solution | Oral | July 2020 | Prescription reference product |
Source: FDA Orange Book, Jazz Pharmaceuticals Ireland Ltd. Listed for sale today by Jazz Pharmaceuticals, Inc. (FDA NDC Directory).
Xywav NDC Codes and Packages
Each Xywav 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 |
|---|---|---|---|
| 68727-0150-01 | SODIUM OXYBATE .5 g/mL / CALCIUM OXYBATE .5 g/mL / POTASSIUM OXYBATE .5 g/mL / MAGNESIUM OXYBATE .5 g/mL solution | bottle of 180 mL | Jazz Pharmaceuticals, Inc. |
| 68727-0150-01 | SODIUM OXYBATE .5 g/mL / CALCIUM OXYBATE .5 g/mL / POTASSIUM OXYBATE .5 g/mL / MAGNESIUM OXYBATE .5 g/mL solution | bottle of 180 mL | Jazz Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Xywav’s own FDA approval (NDA 212690) are listed, never a generic. Some codes belong to companies that repackage Xywav: it is the same medicine in a different package.
What a Generic Xywav Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Xywav 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 Xywav”. 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 Xywav
Is there a generic for Xywav right now?
No. As of October 9, 2026 no generic calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate is listed for sale in the FDA NDC Directory.
When will Xywav go generic?
Sometime in 2033 is the expected window, and that is likely but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to February 2041, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate be the same as Xywav?
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. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Xywav?
Not yet. The FDA Orange Book lists no approved generic version of Xywav.
When does the Xywav patent expire?
The FDA Orange Book lists 16 patents for Xywav; the last runs to February 2041. 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 window on this page (Sometime in 2033) weighs all of that.
Has anyone challenged the Xywav patents?
Yes. The first patent challenge to Xywav reached the FDA in April 2021, from one company on that first day. The FDA has not approved a first challenger’s generic 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.
Changes to This Projection
- First generic expected Sometime in 2033 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
- SavaysaEdoxaban Tosylate2027 to 2028
- NourianzIstradefyllineJanuary 2028
- Invega SustennaPaliperidone PalmitateJanuary 2031
- VerzenioAbemaciclibJanuary to March 2032
- AliqopaCopanlisib DihydrochlorideMarch 2032
- DojolviTriheptanoinDuring 2033
About Xywav
- Generic name calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate
- How it is taken By mouth
- Company Jazz Pharmaceuticals Ireland Ltd
- Patent challenges Since April 2021 (FDA)
- More drugs Brand-name drugs starting with X
- Have a question? A pharmacist answers, free. Ask about Xywav
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, 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.