Ctexli Generic: When Will Generic Chenodiol 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
Ctexli Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2032 About 5.5 years away Why then?
- Has the FDA approved a generic? October 2009 1 company approved
- When does the last FDA protection end? February 2032 FDA exclusivity: orphan drug
- Can you buy a generic today? Yes 2 companies list one
It already is. A generic chenodiol is listed for sale by 2 companies, so ask your pharmacy whether it can fill your prescription with one.
Why February 2032?
It is when Ctexli’s FDA protection for orphan drug ends. Seven years of protection for a use in a rare disease. We rate it probable: more likely than not, but it can still move.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Ctexli, 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.
Ctexli by the Numbers
- Reason
- FDA exclusivity endsFDA gives new drugs a protected period, for example for a rare-disease use. It ends then.
- 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 2025 February 2025 FDA Orange Book
- Patents listed 0 none listed FDA Orange Book
- Generics FDA-approved 1 company, approved October 2009 FDA Orange Book
- Medicare Part D spent $18.2M in 2025, for 40 people CMS Part D Spending by Drug
- Medicaid prescriptions 189 in the last four reported quarters, $9.4M CMS Medicaid drug utilization, to Q1 2026
Ctexli’s Road to a Generic
Ctexli has had the market to itself since the FDA approved it in February 2025 (Mirum Pharmaceuticals Inc). Its FDA protection (orphan drug) runs to February 2032.
The first generic of Ctexli is expected in February 2032.
Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. It ends then.
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.
Ctexli Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ctexli’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.
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | February 2028 | Active |
| Orphan drug ODE-523 | Seven years of protection for a use in a rare disease. | February 2032 | Active |
Source: FDA Orange Book, application 219488. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Chenodiol
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 application count is on record for Ctexli, but the FDA has already approved 1 company (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in October 2009. 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 chenodiol is listed for sale by 2 companies. Ask your pharmacy whether it can fill your prescription with it.
LGM PHARMA SOLUTIONS, LLC and Travere Therapeutics
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Lgm Pharma Solutions LLC | October 2009 | 250MG | – |
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).
Ctexli 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 Ctexli, 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 Ctexli
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 Ctexli, before manufacturer rebates.
- $6.9M
- January to March 2026, the latest CMS has posted
For 37 people, about $59,536 per prescription fill - $18.2M
- 2025, the whole year
For 40 people, about $58,852 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $6,906,209 | 37 | $59,536.28 |
| 2025 | $18,244,260 | 40 | $58,852.45 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ctexli only, so no generic is counted in it. What CMS says it is used for: Chenodiol is used to dissolve certain types of gallstones (non-calcified). Chenodiol is a bile acid.
Medicaid Prescriptions by Quarter
189 prescriptions in the four quarters to Q1 2026, $9.4M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 57 | $2,918,298 |
| Q4 2025 | 68 | $3,410,210 |
| Q3 2025 | 49 | $2,275,604 |
| Q2 2025 | 15 | $766,489 |
Source: CMS Medicaid State Drug Utilization Data, over Ctexli’s own package codes.
Ctexli Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 250MG | Tablet | Oral | February 2025 | Prescription reference product |
Source: FDA Orange Book, Mirum Pharmaceuticals Inc. Listed for sale today by Mirum Pharmaceuticals Inc. (FDA NDC Directory).
Ctexli NDC Codes and Packages
Each Ctexli 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 |
|---|---|---|---|
| 79378-0310-90 | CHENODIOL 250 mg/1 tablet, film coated | bottle of 100 tablets | Mirum Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ctexli’s own FDA approval (NDA 219488) are listed, never a generic. Some codes belong to companies that repackage Ctexli: it is the same medicine in a different package.
What a Generic Ctexli 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 Ctexli
Is there a generic for Ctexli right now?
Yes. The FDA NDC Directory lists a generic chenodiol from 2 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Ctexli go generic?
It already has. The FDA NDC Directory lists a generic chenodiol from 2 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic chenodiol be the same as Ctexli?
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. The FDA has already approved one company to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Ctexli?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in October 2009: Lgm Pharma Solutions LLC. 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 Ctexli patent expire?
No patents are listed for Ctexli in the FDA Orange Book. Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. It ends then.
Changes to This Projection
- First generic expected February 2032 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
- SymtuzaCobicistat, Darunavir, Emtricitabine, and Tenofovir AlafenamideDuring 2032
- Esmolol HydrochlorideEsmolol HydrochlorideMarch 2033
- XcopriCenobamate2035 to 2036
- BaqsimiGlucagon2036 to 2040
- KrazatiAdagrasibMay 2037
- OtiprioCiprofloxacinNovember 2038
About Ctexli
- Generic name chenodiol
- How it is taken By mouth
- Company Mirum Pharmaceuticals Inc
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Ctexli
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, 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.