Xermelo Generic: When Will Generic Telotristat Etiprate 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
Xermelo Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2031 About 4.5 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? February 2031 5 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic telotristat etiprate is expected to be available in February 2031, about 4.5 years away. None is for sale yet.
Why February 2031?
It is when Xermelo’s patent 7,709,493 ends. That patent covers the active ingredient and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.
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 Xermelo 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.
Xermelo by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- None filed yet No filers on record
- Brand sales
- under $10M a yearSmall seller
- FDA approved 2017 February 2017 FDA Orange Book
- Patents listed 5 last runs to February 2031 FDA Orange Book
- Medicare Part D spent $38.8M in 2025, for 577 people CMS Part D Spending by Drug
Xermelo’s Road to a Generic
Xermelo has had the market to itself since the FDA approved it in February 2017 (Tersera Therapeutics LLC). Its 5 listed patents run to February 2031.
The first generic of Xermelo is expected in February 2031.
Why that month: patent 7,709,493, on the active ingredient and a way of using 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.
Xermelo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Xermelo’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 7,709,493, which ends in February 2031, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,553,840 | The active ingredient | December 2027 | Active |
| 7,968,559 | A way of using it (U-1979) | December 2027 | Active |
| 8,653,094 | A way of using it (U-1979) | December 2028 | Active |
| 8,193,204 | The active ingredient | February 2031 | Active |
| 7,709,493 Sets the expected month of generic availability | The active ingredient; a way of using it (U-1979) | February 2031 | Active |
Source: FDA Orange Book, application 208794. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Telotristat Etiprate
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 Xermelo yet.
Approved by the FDA
Not yet. The FDA has not approved a generic telotristat etiprate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic telotristat etiprate 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).
Xermelo 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 Xermelo, 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 Xermelo
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 Xermelo, before manufacturer rebates.
- $12M
- January to March 2026, the latest CMS has posted
For 430 people, about $11,935 per prescription fill - $38.8M
- 2025, the whole year
For 577 people, about $10,615 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $12,018,221 | 430 | $11,934.68 |
| 2025 | $38,765,590 | 577 | $10,614.89 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Xermelo only, so no generic is counted in it. What CMS says it is used for: This medication is used along with another drug (a somatostatin analog such as octreotide) to treat diarrhea due to carcinoid syndrome. Telotristat helps to reduce the number of bowel movements that you may have.
Xermelo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 250MG BASE | Tablet | Oral | February 2017 | Prescription reference product |
Source: FDA Orange Book, Tersera Therapeutics LLC. Listed for sale today by Lexicon Pharmaceuticals, Inc. and TerSera Therapeutics LLC (FDA NDC Directory).
Xermelo NDC Codes and Packages
Each Xermelo 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 |
|---|---|---|---|
| 70183-0125-84 | TELOTRISTAT ETHYL 250 mg/1 tablet | case of 4 boxes of 7 blister packs of 3 tablets | Lexicon Pharmaceuticals, Inc. |
| 70183-0125-85 | TELOTRISTAT ETHYL 250 mg/1 tablet | case of 4 boxes of 4 blister packs of 21 tablets | Lexicon Pharmaceuticals, Inc. |
| 70720-0125-85 | TELOTRISTAT ETHYL 250 mg/1 tablet | case of 4 boxes of 1 blister pack of 21 tablets | TerSera Therapeutics LLC |
| 70720-0125-85 | TELOTRISTAT ETHYL 250 mg/1 tablet | case of 4 boxes of 1 blister pack of 21 tablets | TerSera Therapeutics LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Xermelo’s own FDA approval (NDA 208794) are listed, never a generic. Some codes belong to companies that repackage Xermelo: it is the same medicine in a different package.
What a Generic Xermelo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Xermelo 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 Xermelo”. 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 Xermelo
Is there a generic for Xermelo right now?
No. As of October 9, 2026 no generic telotristat etiprate is listed for sale in the FDA NDC Directory.
When will Xermelo go generic?
February 2031 is the expected month, and that is likely but not certain. It is when Xermelo’s patent 7,709,493 ends. That patent covers the active ingredient and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic telotristat etiprate be the same as Xermelo?
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 Xermelo?
Not yet. The FDA Orange Book lists no approved generic version of Xermelo.
When does the Xermelo patent expire?
The FDA Orange Book lists 5 patents for Xermelo; the last runs to February 2031. The one behind the expected month is patent 7,709,493, which ends in February 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 (February 2031) weighs all of that.
Changes to This Projection
- First generic expected February 2031 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
- AdasuveLoxapineOctober 2026
- NevanacNepafenacJanuary 2027
- VazaloreAspirinSeptember 2032
- DefencathHeparin Sodium and TaurolidineJuly to December 2035
- ImmphentivPhenylephrine HydrochlorideSeptember 2036
- RivflozaNedosiran SodiumOctober 2038
About Xermelo
- Generic name telotristat etiprate
- How it is taken By mouth
- Company Tersera Therapeutics LLC
- More drugs Brand-name drugs starting with X
- Have a question? A pharmacist answers, free. Ask about Xermelo
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.