Trulance Generic: When Will Generic Plecanatide 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
Trulance Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2031 to 2032 A wide window 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? June 2034 10 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 plecanatide is expected to be available between 2031 and 2032. None is for sale yet.
Why 2031 to 2032?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Trulance’s last patent runs to June 2034, how can a generic come sooner?
The 4 patents that run past the expected month, to June 2034 (10,011,637, 11,142,549, 11,834,521 and 12,146,003), cover the active ingredient and the product’s formulation. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Here, a settlement between the companies sets the date. Generic companies have been challenging Trulance’s patents with the FDA since January 2021. 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 $17.84 pharmacies pay per tablet for Trulance today to about $9.99. See the price estimate
What should I do now?
Keep taking Trulance 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.
Trulance by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Moderate 3 companies have filed, 2 first in line
- Brand sales
- $364M a yearBig seller
- FDA approved 2017 January 2017 FDA Orange Book
- Patents listed 10 last runs to June 2034 A generic is expected sooner, between 2031 and 2032. See why FDA Orange Book
- Pharmacies pay $17.84 per tablet NADAC, February 2024
- Medicare Part D spent $128.9M in 2025, for 42.7K people CMS Part D Spending by Drug
- Medicaid prescriptions 29.9K in the last four reported quarters, $19M CMS Medicaid drug utilization, to Q1 2026
Trulance’s Road to a Generic
Trulance has had the market to itself since the FDA approved it in January 2017 (Salix Pharmaceuticals Inc). Its 10 listed patents run to June 2034. Generic companies have challenged its patents with the FDA since January 2021.
The first generic of Trulance is expected between 2031 and 2032.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before June 2034
The last listed patent runs to June 2034; a court ruling or a settlement can bring a generic sooner. 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.
Trulance Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Trulance’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 |
|---|---|---|---|
| 7,041,786 | The active ingredient | January 2028 | Active |
| 9,610,321 | A way of using it (U-1999, U-2230) | September 2031 | Active |
| 9,919,024 | A way of using it (U-2230, U-1999) | September 2031 | Active |
| 9,925,231 | The product’s formulation | September 2031 | Active |
| 11,319,346 | The product’s formulation | March 2032 | Active |
| 9,616,097 | The product’s formulation | August 2032 | Active |
| 10,011,637 | The active ingredient | June 2034 | Active |
| 11,142,549 | The product’s formulation | June 2034 | Active |
| 11,834,521 | The product’s formulation | June 2034 | Active |
| 12,146,003 | The product’s formulation | June 2034 | Active |
Source: FDA Orange Book, application 208745. Patent numbers open the patent on Google Patents.
Patent Challenges to Trulance
The first patent challenge to Trulance reached the FDA in January 2021, from 2 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 Trulance’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, 3 mg | January 2021 | 2 companies | No decision yet | Not yet | Not yet | June 2034 |
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 Plecanatide
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 plecanatide.
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. 2 of them were first in line, both 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 Trulance’s patents with the FDA since January 2021: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic plecanatide. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic plecanatide 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).
Trulance Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Trulance today: $17.84 per tablet for Trulance 3 mg tablet in February 2024, 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). Trulance 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 $17.84 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 Trulance
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 Trulance, before manufacturer rebates.
- $30.1M
- January to March 2026, the latest CMS has posted
For 20,857 people, about $913 per prescription fill - $128.9M
- 2025, the whole year
For 42,704 people, about $843 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $30,073,197 | 20,857 | $912.75 |
| 2025 | $128,886,870 | 42,704 | $843.03 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Trulance only, so no generic is counted in it. What CMS says it is used for: See also Warning section. Plecanatide is used to treat certain types of bowel problems (chronic idiopathic constipation, irritable bowel syndrome with constipation).
Medicaid Prescriptions by Quarter
29,884 prescriptions in the four quarters to Q1 2026, $19M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 0 | $0 |
| Q4 2025 | 134 | $81,106 |
| Q3 2025 | 14,698 | $9,365,355 |
| Q2 2025 | 15,052 | $9,543,481 |
| Q1 2025 | 14,788 | $9,236,582 |
Source: CMS Medicaid State Drug Utilization Data, over Trulance’s own package codes.
Trulance Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 3MG | Tablet | Oral | January 2017 | Prescription reference product |
Source: FDA Orange Book, Salix Pharmaceuticals Inc. Listed for sale today by Salix Pharmaceuticals Inc. and Synergy Pharmaceuticals Inc. (FDA NDC Directory).
Trulance NDC Codes and Packages
Each Trulance 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 |
|---|---|---|---|
| 65649-0003-01 | 3 mg tablet | bottle of 1 tablet | Salix Pharmaceuticals Inc. |
| 65649-0003-01 | 3 mg tablet | bottle of 1 tablet | Salix Pharmaceuticals Inc. |
| 65649-0003-03 | 3 mg tablet | bottle of 3 tablets | Salix Pharmaceuticals Inc. |
| 65649-0003-03 | 3 mg tablet | bottle of 3 tablets | Salix Pharmaceuticals Inc. |
| 65649-0003-07 | 3 mg tablet | bottle of 7 tablets | Salix Pharmaceuticals Inc. |
| 65649-0003-07 | 3 mg tablet | bottle of 7 tablets | Salix Pharmaceuticals Inc. |
| 65649-0003-30 | 3 mg tablet | bottle of 30 tablets | Salix Pharmaceuticals Inc. |
| 65649-0003-30 | 3 mg tablet | bottle of 30 tablets | Salix Pharmaceuticals Inc. |
| 70194-0003-30 | 3 mg tablet | blister pack of 30 tablets | Synergy Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Trulance’s own FDA approval (NDA 208745) are listed, never a generic. Some codes belong to companies that repackage Trulance: it is the same medicine in a different package.
What a Generic Trulance Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Trulance 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 Trulance”. 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 Trulance
Is there a generic for Trulance right now?
No. As of October 9, 2026 no generic plecanatide is listed for sale in the FDA NDC Directory.
When will Trulance go generic?
2031 to 2032 is the expected window, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to June 2034; a court ruling or a settlement can bring a generic sooner.
Will generic plecanatide be the same as Trulance?
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 $17.84 pharmacies pay per tablet for Trulance today to about $9.99. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Trulance?
Not yet. The FDA Orange Book lists no approved generic version of Trulance.
When does the Trulance patent expire?
The FDA Orange Book lists 10 patents for Trulance; the last runs to June 2034. 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 (2031 to 2032) weighs all of that.
Has anyone challenged the Trulance patents?
Yes. The first patent challenge to Trulance reached the FDA in January 2021, from 2 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 Trulance cost now?
Pharmacies paid about $17.84 per tablet for Trulance 3 mg tablet in February 2024, 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 2031 to 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
- JevtanaCabazitaxelDuring 2026
- Vykat XRDiazoxide Choline2034 to 2035
- EmcitateTiratricolMarch 2034
- SotylizeSotalol HydrochlorideNovember 2034
- AsteproAzelastine HydrochlorideTBD no date yet
- OnsolisFentanyl CitrateTBD no date yet
About Trulance
- Generic name plecanatide
- How it is taken By mouth
- Company Salix Pharmaceuticals 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 January 2021 (FDA)
- More drugs Brand-name drugs starting with T
- Have a question? A pharmacist answers, free. Ask about Trulance
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.