Lybalvi 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
Lybalvi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2033 About 6.5 years away 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? November 2041 14 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 olanzapine and samidorphan l-malate is expected to be available in May 2033, about 6.5 years away. None is for sale yet.
Why May 2033?
It is when Lybalvi’s patent 10,300,054 ends. That patent covers the product’s formulation and a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Lybalvi’s last patent runs to November 2041, how can a generic come sooner?
The 3 patents that run past the expected month, to November 2041 (11,707,466, 11,951,111 and 12,390,474), cover the product’s formulation and 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. Generic companies have been challenging Lybalvi’s patents with the FDA since May 2025. 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, which would take the $55.21 pharmacies pay per tablet for Lybalvi today to about $30.92. See the price estimate
What should I do now?
Keep taking Lybalvi 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.
Lybalvi by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Moderate 3 companies have filed, 3 first in line
- Brand sales
- $409M a yearBig seller
- FDA approved 2021 May 2021 FDA Orange Book
- Patents listed 14 last runs to November 2041 A generic is expected sooner, in May 2033. See why FDA Orange Book
- Pharmacies pay $55.21 per tablet, up 10% in a year NADAC, October 2026
- Medicare Part D spent $163M in 2025, for 13.7K people CMS Part D Spending by Drug
- Medicaid prescriptions 131K in the last four reported quarters, $209.3M CMS Medicaid drug utilization, to Q1 2026
Lybalvi’s Road to a Generic
Lybalvi has had the market to itself since the FDA approved it in May 2021 (Alkermes Inc). Its FDA protections on record ended by May 2026. Its 14 listed patents run to November 2041. Generic companies have challenged its patents with the FDA since May 2025.
The first generic of Lybalvi is expected in May 2033.
Why that month: patent 10,300,054, on the product’s formulation and a way of using it, ends then. That is about 8.5 years before the last listed patent runs out, in November 2041.
Why a Generic Can Come Before November 2041
The last listed patent runs to November 2041, but it covers the product’s formulation and 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.
Lybalvi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Lybalvi’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.
The one that matters for a generic launch: patent 10,300,054, which ends in May 2033, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,126,977 | The product’s formulation; a way of using it (U-3136, U-3137) | August 2031 | Active |
| 9,517,235 | A way of using it (U-3139, U-3138) | August 2031 | Active |
| 10,716,785 | A way of using it (U-3136, U-3137) | August 2031 | Active |
| 11,185,541 | A way of using it (U-3140) | August 2031 | Active |
| 11,241,425 | A way of using it (U-3137) | August 2031 | Active |
| 11,351,166 | A way of using it (U-3140, U-3141) | August 2031 | Active |
| 11,793,805 | A way of using it (U-3734) | August 2031 | Active |
| 12,194,035 | A way of using it (U-3141) | August 2031 | Active |
| 9,119,848 | The active ingredient | August 2031 | Active |
| 8,778,960 | A way of using it (U-3136, U-3137) | February 2032 | Active |
| 10,300,054 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3140, U-3141) | May 2033 | Active |
| 11,707,466 | The product’s formulation | November 2041 | Active |
| 11,951,111 | A way of using it (U-3886, U-3887) | November 2041 | Active |
| 12,390,474 | The product’s formulation | November 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | May 2026 | Ended |
Source: FDA Orange Book, application 213378. Patent numbers open the patent on Google Patents.
Patent Challenges to Lybalvi
The first patent challenge to Lybalvi reached the FDA in May 2025, from 3 companies 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 Lybalvi’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, 5 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg | May 2025 | 3 companies | No decision yet | Not yet | Not yet | November 2041 |
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 Olanzapine and Samidorphan L-malate
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 olanzapine and samidorphan l-malate.
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. 3 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 Lybalvi’s patents with the FDA since May 2025: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic olanzapine and samidorphan l-malate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic olanzapine and samidorphan l-malate 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).
Lybalvi Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Lybalvi 5-10 mg tablet
$55.21 per tablet in October 2026, up 10% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Lybalvi 5-10 mg tablet $55.21 per tablet
- Lybalvi 10-10 mg tablet $55.10 per tablet
- Lybalvi 15-10 mg tablet $55.12 per tablet
- Lybalvi 20-10 mg tablet $54.98 per tablet
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $55.21 |
| September 2026 | $55.21 |
| August 2026 | $55.21 |
| July 2026 | $55.26 |
| June 2026 | $55.28 |
| May 2026 | $55.33 |
| April 2026 | $55.13 |
| March 2026 | $55.13 |
| February 2026 | $55.13 |
| January 2026 | $55.13 |
| February 2024 | $50.17 |
| January 2024 | $50.17 |
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 Lybalvi today: $55.21 per tablet for Lybalvi 5-10 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). Lybalvi has 3 companies lined up, so our estimate uses the figure for two companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $55.21 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 Lybalvi
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 Lybalvi, before manufacturer rebates.
- $41M
- January to March 2026, the latest CMS has posted
For 9,955 people, about $1,735 per prescription fill - $163M
- 2025, the whole year
For 13,713 people, about $1,679 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $40,992,217 | 9,955 | $1,735.19 |
| 2025 | $162,995,231 | 13,713 | $1,678.63 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Lybalvi only, so no generic is counted in it. What CMS says it is used for: This combination medication is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder). Olanzapine belongs to a class of drugs called atypical antipsychotics.
Medicaid Prescriptions by Quarter
130,976 prescriptions in the four quarters to Q1 2026, $209.3M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 33,239 | $54,806,259 |
| Q4 2025 | 33,933 | $53,741,442 |
| Q3 2025 | 33,609 | $53,098,796 |
| Q2 2025 | 30,195 | $47,632,089 |
| Q1 2025 | 27,946 | $44,307,525 |
Source: CMS Medicaid State Drug Utilization Data, over Lybalvi’s own package codes.
Lybalvi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG;EQ 10MG BASE | Tablet | Oral | May 2021 | Prescription reference product |
| 15MG;EQ 10MG BASE | Tablet | Oral | May 2021 | Prescription reference product |
| 20MG;EQ 10MG BASE | Tablet | Oral | May 2021 | Prescription reference product |
| 5MG;EQ 10MG BASE | Tablet | Oral | May 2021 | Prescription reference product |
Source: FDA Orange Book, Alkermes Inc. Listed for sale today by Alkermes, Inc. (FDA NDC Directory).
Lybalvi NDC Codes and Packages
Each Lybalvi 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 |
|---|---|---|---|
| 65757-0652-02 | OLANZAPINE 10 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | container of 192,308 tablets | Alkermes, Inc. |
| 65757-0652-40 | OLANZAPINE 10 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0652-41 | OLANZAPINE 10 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0652-41 | OLANZAPINE 10 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0652-42 | OLANZAPINE 10 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 30 tablets | Alkermes, Inc. |
| 65757-0652-42 | OLANZAPINE 10 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 30 tablets | Alkermes, Inc. |
| 65757-0652-44 | OLANZAPINE 10 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 90 tablets | Alkermes, Inc. |
| 65757-0653-03 | OLANZAPINE 15 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | container of 153,846 tablets | Alkermes, Inc. |
Show the other 20 Lybalvi packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 65757-0653-40 | OLANZAPINE 15 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0653-41 | OLANZAPINE 15 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0653-41 | OLANZAPINE 15 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0653-42 | OLANZAPINE 15 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 30 tablets | Alkermes, Inc. |
| 65757-0653-42 | OLANZAPINE 15 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 30 tablets | Alkermes, Inc. |
| 65757-0653-44 | OLANZAPINE 15 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 90 tablets | Alkermes, Inc. |
| 65757-0654-04 | OLANZAPINE 20 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | container of 128,205 tablets | Alkermes, Inc. |
| 65757-0654-40 | OLANZAPINE 20 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0654-41 | OLANZAPINE 20 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0654-41 | OLANZAPINE 20 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0654-42 | OLANZAPINE 20 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 30 tablets | Alkermes, Inc. |
| 65757-0654-42 | OLANZAPINE 20 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 30 tablets | Alkermes, Inc. |
| 65757-0654-44 | OLANZAPINE 20 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 90 tablets | Alkermes, Inc. |
| 65757-0651-01 | OLANZAPINE 5 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | container of 256,410 tablets | Alkermes, Inc. |
| 65757-0651-40 | OLANZAPINE 5 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0651-41 | OLANZAPINE 5 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0651-41 | OLANZAPINE 5 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 7 tablets | Alkermes, Inc. |
| 65757-0651-42 | OLANZAPINE 5 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 30 tablets | Alkermes, Inc. |
| 65757-0651-42 | OLANZAPINE 5 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 30 tablets | Alkermes, Inc. |
| 65757-0651-44 | OLANZAPINE 5 mg/1 / SAMIDORPHAN L-MALATE 10 mg/1 tablet, film coated | bottle of 90 tablets | Alkermes, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Lybalvi’s own FDA approval (NDA 213378) are listed, never a generic. Some codes belong to companies that repackage Lybalvi: it is the same medicine in a different package.
What a Generic Lybalvi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Lybalvi 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 Lybalvi”. 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 Lybalvi
Is there a generic for Lybalvi right now?
No. As of October 9, 2026 no generic olanzapine and samidorphan l-malate is listed for sale in the FDA NDC Directory.
When will Lybalvi go generic?
May 2033 is the expected month, and that is probable but not certain. It is when Lybalvi’s patent 10,300,054 ends. That patent covers the product’s formulation and a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to November 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic olanzapine and samidorphan l-malate be the same as Lybalvi?
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, which would take the $55.21 pharmacies pay per tablet for Lybalvi today to about $30.92. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Lybalvi?
Not yet. The FDA Orange Book lists no approved generic version of Lybalvi.
When does the Lybalvi patent expire?
The FDA Orange Book lists 14 patents for Lybalvi; the last runs to November 2041. The one behind the expected month is patent 10,300,054, which ends in May 2033. 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 (May 2033) weighs all of that.
Has anyone challenged the Lybalvi patents?
Yes. The first patent challenge to Lybalvi reached the FDA in May 2025, from 3 companies 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.
How much does Lybalvi cost now?
Pharmacies paid about $55.21 per tablet for Lybalvi 5-10 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 May 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
- EliquisApixabanApril 2028
- Arcapta NeohalerIndacaterol MaleateOctober 2028
- JatenzoTestosterone Undecanoate2034 to 2035
- OmlontiOmidenepag IsopropylJanuary 2035
- VtamaTapinarof2036 to 2037
- Sotalol Hydrochloride IVSotalol HydrochlorideTBD no date yet
About Lybalvi
- Generic name olanzapine and samidorphan l-malate
- 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 2025 (FDA)
- More drugs Brand-name drugs starting with L
- Have a question? A pharmacist answers, free. Ask about Lybalvi
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.