Lynavoy Generic: When Will Generic Linerixibat 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
Lynavoy Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? October 2041 About 15 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 FDA protection end? March 2033 FDA exclusivity: orphan drug
- Can you buy a generic today? Not yet No company lists one for sale
Generic linerixibat is expected to be available in October 2041, about 15 years away. None is for sale yet.
Why October 2041?
A patent that protects the brand runs out. After that, approved generics can be sold. We rate it probable: more likely than not, but it can still move.
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, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Lynavoy 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.
Lynavoy 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
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2026 March 2026 FDA Orange Book
- Patents listed 1 last runs to September 2031 FDA Orange Book
Lynavoy’s Road to a Generic
Lynavoy has had the market to itself since the FDA approved it in March 2026 (Intercept Pharmaceuticals Inc). Its FDA protection (orphan drug) runs to March 2033. Its one listed patent runs to September 2031.
The first generic of Lynavoy is expected in October 2041.
Why that month: a patent that protects the brand runs out. After that, approved generics can be sold.
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.
Lynavoy Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Lynavoy’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 |
|---|---|---|---|
| 9,040,518 | The active ingredient; the product’s formulation | September 2031 | 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. | March 2031 | Active |
| Orphan drug ODE-517 | Seven years of protection for a use in a rare disease. | March 2033 | Active |
Source: FDA Orange Book, application 220295. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Linerixibat
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
No company is recorded as having applied to the FDA to make a generic Lynavoy yet.
Approved by the FDA
Not yet. The FDA has not approved a generic linerixibat. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic linerixibat 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).
Lynavoy 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 Lynavoy, 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.
Lynavoy Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 40MG | Tablet | Oral | March 2026 | Prescription reference product |
Source: FDA Orange Book, Intercept Pharmaceuticals Inc. Listed for sale today by Intercept Pharmaceuticals Inc (FDA NDC Directory).
Lynavoy NDC Codes and Packages
Each Lynavoy 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 |
|---|---|---|---|
| 69516-0140-60 | LINERIXIBAT 40 mg/1 tablet, film coated | bottle of 60 tablets | Intercept Pharmaceuticals Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Lynavoy’s own FDA approval (NDA 220295) are listed, never a generic. Some codes belong to companies that repackage Lynavoy: it is the same medicine in a different package.
What a Generic Lynavoy Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Lynavoy 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 Lynavoy”. 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 Lynavoy
Is there a generic for Lynavoy right now?
No. As of October 9, 2026 no generic linerixibat is listed for sale in the FDA NDC Directory.
When will Lynavoy go generic?
October 2041 is the expected month, and that is probable but not certain. A patent that protects the brand runs out. After that, approved generics can be sold.
Will generic linerixibat be the same as Lynavoy?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Lynavoy?
Not yet. The FDA Orange Book lists no approved generic version of Lynavoy.
When does the Lynavoy patent expire?
One patent is listed for Lynavoy in the FDA Orange Book; it runs to September 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 (October 2041) weighs all of that.
Changes to This Projection
- First generic expected October 2041 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
- EllaUlipristal AcetateDuring 2026
- OnapgoApomorphine HydrochlorideFebruary 2032
- SotylizeSotalol HydrochlorideNovember 2034
- JaypircaPirtobrutinibDuring 2037
- AristadaAripiprazole LauroxilApril 2039
- VyalevFoscarbidopa and FoslevodopaJune 2040
About Lynavoy
- Generic name linerixibat
- How it is taken By mouth
- Company Intercept Pharmaceuticals Inc
- More drugs Brand-name drugs starting with L
- Have a question? A pharmacist answers, free. Ask about Lynavoy
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, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.