Plenvu 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
Plenvu Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2028 to 2029 A wide window Why then?
- Has the FDA approved a generic? January 2012 1 company approved Why not on sale?
- When does the last patent end? September 2033 11 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 ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium ascorbate, sodium chloride, and sodium sulfate is expected to be available between 2028 and 2029. None is for sale yet.
Why 2028 to 2029?
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 Plenvu’s last patent runs to September 2033, how can a generic come sooner?
The 11 patents that run past the expected month, to September 2033 (10,780,112, 10,792,306, 11,529,368, 10,646,512 and 7 more), 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. Here, a settlement between the companies sets the date. Generic companies have been challenging Plenvu’s patents with the FDA since December 2018. That is why the expected month comes before the last protection ends. See the road to a generic
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since January 2012, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 2 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 $45.14 pharmacies pay each for Plenvu today to about $25.28. See the price estimate
What should I do now?
Keep taking Plenvu 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.
Plenvu 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 2 companies have filed, 1 first in line
- Brand sales
- $38M a yearSmaller seller
- FDA approved 2018 May 2018 FDA Orange Book
- Patents listed 11 last runs to September 2033 A generic is expected sooner, between 2028 and 2029. See why FDA Orange Book
- Generics FDA-approved 1 company, approved January 2012 FDA Orange Book
- Pharmacies pay $45.14 each NADAC, February 2024
- Medicare Part D spent $5.7M in 2025, for 39.1K people CMS Part D Spending by Drug
- Medicaid prescriptions 5,485 in the last four reported quarters, $800.3K CMS Medicaid drug utilization, to Q4 2025
Plenvu’s Road to a Generic
Plenvu has had the market to itself since the FDA approved it in May 2018 (Norgine BV). Its 11 listed patents run to September 2033. Generic companies have challenged its patents with the FDA since December 2018.
The first generic of Plenvu is expected between 2028 and 2029.
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 September 2033
The last listed patent runs to September 2033, 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.
Plenvu Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Plenvu’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 |
|---|---|---|---|
| 10,780,112 | The product’s formulation | March 2032 | Active |
| 10,792,306 | The product’s formulation; a way of using it (U-2310) | March 2032 | Active |
| 11,529,368 | The product’s formulation; a way of using it (U-2310) | March 2032 | Active |
| 10,646,512 | The product’s formulation | March 2032 | Active |
| 9,592,252 | The product’s formulation; a way of using it (U-2310) | August 2032 | Active |
| 8,999,313 | The product’s formulation | September 2033 | Active |
| 9,326,969 | A way of using it (U-2310) | September 2033 | Active |
| 9,707,297 | The product’s formulation | September 2033 | Active |
| 10,016,504 | The product’s formulation | September 2033 | Active |
| 10,918,723 | A way of using it (U-2310) | September 2033 | Active |
| 12,083,179 | The product’s formulation; a way of using it (U-2310) | September 2033 | Active |
Source: FDA Orange Book, application 209381. Patent numbers open the patent on Google Patents.
Patent Challenges to Plenvu
The first patent challenge to Plenvu reached the FDA in December 2018, from one company on that first day.
What Is a Patent Challenge?
A generic company that wants to sell its version before Plenvu’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 | |||||
| For oral solution, 140 g, 5.2 g, 2.2.g, 48.11 g, 9 g and 7.54 g per pouch | December 2018 | 1 company | Not posted | Not posted | Not posted | September 2033 |
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 Ascorbic Acid, Polyethylene Glycol 3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, and Sodium Sulfate
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
2 companies have applied to the FDA to make generic ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium ascorbate, sodium chloride, and sodium sulfate.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Plenvu’s patents with the FDA since December 2018: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in January 2012. 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
Not yet. No company lists a generic ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium ascorbate, sodium chloride, and sodium sulfate for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Novel Laboratories Inc | January 2012 | 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM | AA |
| Taro Pharmaceutical Industries Ltd discontinued | June 2024 | 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM | – |
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).
Plenvu 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 Plenvu today: $45.14 each for Plenvu powder packets 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). Plenvu has 2 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 $45.14 pharmacies pay each 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 Plenvu
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 Plenvu, before manufacturer rebates.
- $1.4M
- January to March 2026, the latest CMS has posted
For 8,963 people, about $149 per prescription fill - $5.7M
- 2025, the whole year
For 39,138 people, about $141 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $1,353,158 | 8,963 | $149.09 |
| 2025 | $5,661,132 | 39,138 | $141.48 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Plenvu only, so no generic is counted in it. What CMS says it is used for: PEG (polyethylene glycol) with electrolyte is used to clean out the intestines before certain bowel exam procedures such as colonoscopy. It is a laxative that works by drawing large amounts of water into the colon.
Medicaid Prescriptions by Quarter
5,485 prescriptions in the four quarters to Q4 2025, $800.3K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 0 | $0 |
| Q3 2025 | 1,624 | $235,720 |
| Q2 2025 | 1,911 | $279,544 |
| Q1 2025 | 1,950 | $284,992 |
Source: CMS Medicaid State Drug Utilization Data, over Plenvu’s own package codes.
Plenvu Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | For solution | Oral | May 2018 | Prescription reference product |
Source: FDA Orange Book, Norgine BV. Listed for sale today by Salix Pharmaceuticals, Inc (FDA NDC Directory).
Plenvu NDC Codes and Packages
Each Plenvu 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 |
|---|---|---|---|
| 65649-0400-01 | kit | 1 KIT in 1 CARTON * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH | Salix Pharmaceuticals, Inc |
| 65649-0400-01 | kit | 1 KIT in 1 CARTON * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH | Salix Pharmaceuticals, Inc |
| 65649-0400-02 | kit | 1 KIT in 1 CARTON * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH | Salix Pharmaceuticals, Inc |
| 65649-0400-02 | kit | 1 KIT in 1 CARTON * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH | Salix Pharmaceuticals, Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Plenvu’s own FDA approval (NDA 209381) are listed, never a generic. Some codes belong to companies that repackage Plenvu: it is the same medicine in a different package.
What a Generic Plenvu Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Plenvu 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 Plenvu”. 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 Plenvu
Is there a generic for Plenvu right now?
No. As of October 9, 2026 no generic ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium ascorbate, sodium chloride, and sodium sulfate is listed for sale in the FDA NDC Directory. 2 generic versions are FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Plenvu go generic?
2028 to 2029 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 September 2033, 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 ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium ascorbate, sodium chloride, and sodium sulfate be the same as Plenvu?
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. 2 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 $45.14 pharmacies pay each for Plenvu today to about $25.28. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Plenvu?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in January 2012: Novel Laboratories Inc. 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 Plenvu patent expire?
The FDA Orange Book lists 11 patents for Plenvu; the last runs to September 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 window on this page (2028 to 2029) weighs all of that.
Has anyone challenged the Plenvu patents?
Yes. The first patent challenge to Plenvu reached the FDA in December 2018, from one company on that first day. 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 Plenvu cost now?
Pharmacies paid about $45.14 each for Plenvu powder packets 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 2028 to 2029 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
- NulibryFosdenopterin HydrobromideApril 2029
- InveltysLoteprednol EtabonateMay 2033
- SecuadoAsenapineJuly 2033
- ViltepsoViltolarsenApril 2034
- AlyftrekDeutivacaftor, Tezacaftor, and Vanzacaftor CalciumFebruary 2039
- Doryx MPCDoxycycline HyclateTBD no date yet
About Plenvu
- Generic name ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium ascorbate, sodium chloride, and sodium sulfate
- How it is taken By mouth
- Company Norgine BV
- Patent challenges Since December 2018 (FDA)
- More drugs Brand-name drugs starting with P
- Have a question? A pharmacist answers, free. Ask about Plenvu
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.