Lumryz Generic: When Will Generic Sodium Oxybate 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
Lumryz Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2039 to 2040 A wide window Why then?
- Has the FDA approved a generic? January 2017 2 companies approved
- When does the last patent end? March 2042 29 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 5 companies list one
It already is. A generic sodium oxybate is listed for sale by 5 companies, so ask your pharmacy whether it can fill your prescription with one.
Why 2039 to 2040?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Lumryz’s last patent runs to March 2042, how can a generic come sooner?
The 2 patents that run past the expected month, to March 2042 (11,583,510 and 11,779,557), 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 Lumryz’s patents with the FDA since May 2026. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Lumryz, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Lumryz 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
- Probable More likely than not, but it can still move.
- Price competition
- Low 1 company has filed
- Brand sales
- $465M a yearBig seller
- FDA approved 2023 May 2023 FDA Orange Book
- Patents listed 29 last runs to March 2042 FDA Orange Book
- Generics FDA-approved 2 companies, the first approved January 2017 FDA Orange Book
- Medicare Part D spent $34.7M in 2025, for 316 people CMS Part D Spending by Drug
Lumryz’s Road to a Generic
Lumryz has had the market to itself since the FDA approved it in May 2023 (Alkermes Inc). Its FDA protection (orphan drug) runs to October 2031. Its 29 listed patents run to March 2042. Generic companies have challenged its patents with the FDA since May 2026.
The first generic of Lumryz is expected between 2039 and 2040.
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 March 2042
The last listed patent runs to March 2042, 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.
Lumryz Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Lumryz’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 |
|---|---|---|---|
| 10,272,062 | The product’s formulation | July 2037 | Active |
| 10,736,866 | The product’s formulation | July 2037 | Active |
| 10,952,986 | A way of using it (U-3601) | July 2037 | Active |
| 10,973,795 | The product’s formulation | July 2037 | Active |
| 11,000,498 | The product’s formulation; a way of using it (U-3580) | July 2037 | Active |
| 11,052,061 | The product’s formulation | July 2037 | Active |
| 11,065,224 | The product’s formulation | July 2037 | Active |
| 11,400,065 | A way of using it (U-3579) | July 2037 | Active |
| 11,504,347 | The product’s formulation | July 2037 | Active |
| 11,602,512 | A way of using it (U-3577) | July 2037 | Active |
| 11,602,513 | A way of using it (U-3576) | July 2037 | Active |
| 11,766,418 | The product’s formulation | July 2037 | Active |
| 11,826,335 | A way of using it (U-3751) | July 2037 | Active |
| 11,839,597 | The product’s formulation | July 2037 | Active |
| 11,896,572 | The product’s formulation | July 2037 | Active |
| 11,986,451 | A way of using it (U-3934) | July 2037 | Active |
| 12,097,175 | The product’s formulation | July 2037 | Active |
| 12,097,176 | A way of using it (U-4006) | July 2037 | Active |
| 12,109,186 | The product’s formulation | July 2037 | Active |
| 12,115,142 | The product’s formulation | July 2037 | Active |
| 12,115,143 | The product’s formulation | July 2037 | Active |
| 12,115,144 | The product’s formulation | July 2037 | Active |
| 12,115,145 | The product’s formulation | July 2037 | Active |
| 12,128,021 | A way of using it (U-4022) | July 2037 | Active |
| 12,138,239 | The product’s formulation | July 2037 | Active |
| 12,144,793 | The product’s formulation | July 2037 | Active |
| 12,303,478 | A way of using it (U-4189) | July 2037 | Active |
| 11,583,510 | A way of using it (U-3578) | February 2042 | Active |
| 11,779,557 | A way of using it (U-3705) | March 2042 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | May 2026 | Ended |
| Orphan drug ODE-431 | Seven years of protection for a use in a rare disease. | May 2030 | Active |
| Orphan drug ODE-494 | Seven years of protection for a use in a rare disease. | October 2031 | Active |
Source: FDA Orange Book, application 214755. Patent numbers open the patent on Google Patents.
Patent Challenges to Lumryz
The first patent challenge to Lumryz reached the FDA in May 2026, 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 Lumryz’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 | |||||
| For extended-release oral suspension, 4.5 g/packet 6 g/packet 7.5 g/packet 9 g/packet | May 2026 | 1 company | No decision yet | Not yet | Not yet | March 2042 |
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 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
At least 3 companies have applied to the FDA to make generic sodium oxybate.
The FDA has tentatively approved one company’s generic: Ohm Labs Inc (January 2017). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
Generic companies have challenged Lumryz’s patents with the FDA since May 2026: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 2 companies, the first in January 2017. 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
Yes. A generic sodium oxybate is listed for sale by 5 companies. Ask your pharmacy whether it can fill your prescription with it.
Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals NY LLC, Camber Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc. and XLCare Pharmaceuticals, Inc.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Amneal Pharmaceuticals LLC | September 2025 | 0.5GM/ML | AA |
| Ascent Pharmaceuticals Inc | November 2025 | 0.5GM/ML | AA |
| Hikma Pharmaceuticals USA Inc discontinued | January 2017 | 0.5GM/ML | – |
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).
Lumryz 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 Lumryz, 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 Lumryz
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 Lumryz, before manufacturer rebates.
- $10.8M
- January to March 2026, the latest CMS has posted
For 250 people, about $17,753 per prescription fill - $34.7M
- 2025, the whole year
For 316 people, about $16,687 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $10,793,955 | 250 | $17,753.22 |
| 2025 | $34,676,415 | 316 | $16,687.40 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Lumryz only, so no generic is counted in it. What CMS says it is used for: See also Warning section. Sodium oxybate is used to treat narcolepsy, a condition that causes severe daytime sleepiness.
Lumryz Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 4.5GM/PACKET | For suspension, extended release | Oral | May 2023 | Prescription reference product |
| 6GM/PACKET | For suspension, extended release | Oral | May 2023 | Prescription reference product |
| 7.5GM/PACKET | For suspension, extended release | Oral | May 2023 | Prescription reference product |
| 9GM/PACKET | For suspension, extended release | Oral | May 2023 | Prescription reference product |
Source: FDA Orange Book, Alkermes Inc. Listed for sale today by Avadel CNS Pharmaceuticals, LLC and Alkermes, Inc. (FDA NDC Directory).
Lumryz NDC Codes and Packages
Each Lumryz 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 |
|---|---|---|---|
| 13551-0001-07 | SODIUM OXYBATE 4.5 g/1 for suspension, extended release | carton of 7 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0001-07 | SODIUM OXYBATE 4.5 g/1 for suspension, extended release | carton of 7 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0001-30 | SODIUM OXYBATE 4.5 g/1 for suspension, extended release | carton of 30 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0001-30 | SODIUM OXYBATE 4.5 g/1 for suspension, extended release | carton of 30 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0002-07 | SODIUM OXYBATE 6 g/1 for suspension, extended release | carton of 7 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0002-07 | SODIUM OXYBATE 6 g/1 for suspension, extended release | carton of 7 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0002-30 | SODIUM OXYBATE 6 g/1 for suspension, extended release | carton of 30 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0002-30 | SODIUM OXYBATE 6 g/1 for suspension, extended release | carton of 30 packets of 1 for suspension | Alkermes, Inc. |
Show the other 9 Lumryz packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 13551-0003-07 | SODIUM OXYBATE 7.5 g/1 for suspension, extended release | carton of 7 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0003-07 | SODIUM OXYBATE 7.5 g/1 for suspension, extended release | carton of 7 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0003-30 | SODIUM OXYBATE 7.5 g/1 for suspension, extended release | carton of 30 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0003-30 | SODIUM OXYBATE 7.5 g/1 for suspension, extended release | carton of 30 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0004-07 | SODIUM OXYBATE 9 g/1 for suspension, extended release | carton of 7 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0004-07 | SODIUM OXYBATE 9 g/1 for suspension, extended release | carton of 7 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0004-30 | SODIUM OXYBATE 9 g/1 for suspension, extended release | carton of 30 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0004-30 | SODIUM OXYBATE 9 g/1 for suspension, extended release | carton of 30 packets of 1 for suspension | Alkermes, Inc. |
| 13551-0005-01 | kit | 1 KIT in 1 CARTON * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET | Alkermes, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Lumryz’s own FDA approval (NDA 214755) are listed, never a generic. Some codes belong to companies that repackage Lumryz: it is the same medicine in a different package.
What a Generic Lumryz Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Lumryz
Is there a generic for Lumryz right now?
Yes. The FDA NDC Directory lists a generic sodium oxybate from 5 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Lumryz go generic?
It already has. The FDA NDC Directory lists a generic sodium oxybate from 5 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic sodium oxybate be the same as Lumryz?
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. At least 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 Lumryz?
Yes. The FDA Orange Book lists approved generic versions from 2 companies, the first approved in January 2017: Amneal Pharmaceuticals LLC and Ascent Pharmaceuticals Inc. 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 Lumryz patent expire?
The FDA Orange Book lists 29 patents for Lumryz; the last runs to March 2042. 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 (2039 to 2040) weighs all of that.
Has anyone challenged the Lumryz patents?
Yes. The first patent challenge to Lumryz reached the FDA in May 2026, 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 2039 to 2040 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
- OlysioSimeprevir SodiumJuly 2027
- Jakafi XRRuxolitinib Phosphate2030 to 2031
- AqvesmeMitapivat Sulfate2038 to 2039
- SofdraSofpironium BromideJune 2038
- VoxzogoVosoritide2039 to 2040
- EkterlySebetralstatMay 2039
About Lumryz
- Generic name sodium oxybate
- How it is taken By mouth
- Company Alkermes Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since May 2026 (FDA)
- More drugs Brand-name drugs starting with L
- Have a question? A pharmacist answers, free. Ask about Lumryz
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.