Suflave 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
Suflave Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? June 2044 About 17.5 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? August 2044 4 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 magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, and sodium sulfate is expected to be available in June 2044, about 17.5 years away. None is for sale yet.
Why June 2044?
It is when Suflave’s patents 12,239,659, 12,433,914, 12,594,298 and 12,290,529 end. They cover a way of using it and the product’s formulation, and once they end, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Suflave’s last patent runs to August 2044, how can a generic come sooner?
The patent that runs to August 2044 (12,290,529) covers the product’s formulation. 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. Generic companies have been challenging Suflave’s patents with the FDA since April 2025. 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. 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 $61.65 pharmacies pay each for Suflave today to about $34.52. See the price estimate
What should I do now?
Keep taking Suflave 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.
Suflave 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
- Moderate 2 companies have filed, 1 first in line
- Brand sales
- $61M a yearSmaller seller
- FDA approved 2023 June 2023 FDA Orange Book
- Patents listed 4 last runs to August 2044 A generic is expected sooner, in June 2044. See why FDA Orange Book
- Pharmacies pay $61.65 each, up 4.4% in a year NADAC, October 2026
- Medicare Part D spent $8.6M in 2025, for 66.4K people CMS Part D Spending by Drug
- Medicaid prescriptions 32.4K in the last four reported quarters, $4.2M CMS Medicaid drug utilization, to Q1 2026
Suflave’s Road to a Generic
Suflave has had the market to itself since the FDA approved it in June 2023 (Azurity Pharmaceuticals Inc). Its FDA protections on record ended by June 2026. Its 4 listed patents run to August 2044. Generic companies have challenged its patents with the FDA since April 2025.
The first generic of Suflave is expected in June 2044.
Why that month: patents 12,239,659, 12,433,914, 12,594,298 and 12,290,529, on a way of using it and the product’s formulation, end then. That is a few months before the last listed patent runs out, in August 2044.
Why a Generic Can Come Before August 2044
The last listed patent runs to August 2044, but it covers the product’s formulation, 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.
Suflave Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Suflave’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: patents 12,239,659, 12,433,914, 12,594,298 and 12,290,529, which end in June 2044, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 12,239,659 Sets the expected month of generic availability | A way of using it (U-4143) | June 2044 | Active |
| 12,433,914 Sets the expected month of generic availability | A way of using it (U-4143) | June 2044 | Active |
| 12,594,298 Sets the expected month of generic availability | The product’s formulation | June 2044 | Active |
| 12,290,529 Sets the expected month of generic availability | The product’s formulation | August 2044 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | June 2026 | Ended |
Source: FDA Orange Book, application 215344. Patent numbers open the patent on Google Patents.
Patent Challenges to Suflave
The first patent challenge to Suflave reached the FDA in April 2025, from one company 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 Suflave’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, 178.7 g/7.3 g/1.12 g/0.9g/0.5 g | April 2025 | 1 company | No decision yet | Not yet | Not yet | June 2044 |
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 Magnesium Sulfate, Polyethylene Glycol 3350, Potassium Chloride, 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 magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, and sodium sulfate.
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. 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 Suflave’s patents with the FDA since April 2025: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, and sodium sulfate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, and sodium sulfate 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).
Suflave Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Suflave powder
$61.65 each in October 2026, up 4.4% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid each |
|---|---|
| October 2026 | $61.65 |
| September 2026 | $61.65 |
| August 2026 | $61.65 |
| July 2026 | $61.65 |
| June 2026 | $61.65 |
| May 2026 | $61.64 |
| April 2026 | $61.63 |
| March 2026 | $61.63 |
| February 2026 | $61.63 |
| January 2026 | $61.68 |
| February 2024 | $59.05 |
| January 2024 | $59.05 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Suflave today: $61.65 each for Suflave powder in October 2026, 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). Suflave 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 $61.65 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 Suflave
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 Suflave, before manufacturer rebates.
- $2M
- January to March 2026, the latest CMS has posted
For 15,765 people, about $126 per prescription fill - $8.6M
- 2025, the whole year
For 66,436 people, about $126 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,003,103 | 15,765 | $125.52 |
| 2025 | $8,565,854 | 66,436 | $125.61 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Suflave 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 or barium enema X-rays. It is a laxative that works by drawing large amounts of water into the colon.
Medicaid Prescriptions by Quarter
32,363 prescriptions in the four quarters to Q1 2026, $4.2M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 8,743 | $1,143,610 |
| Q4 2025 | 8,369 | $1,091,665 |
| Q3 2025 | 8,659 | $1,124,318 |
| Q2 2025 | 6,592 | $847,213 |
| Q1 2025 | 5,058 | $661,970 |
Source: CMS Medicaid State Drug Utilization Data, over Suflave’s own package codes.
Suflave Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT | For solution | Oral | June 2023 | Prescription reference product |
Source: FDA Orange Book, Azurity Pharmaceuticals Inc. Listed for sale today by Braintree Laboratories, Inc. and Azurity Pharmaceuticals, Inc. (FDA NDC Directory).
Suflave NDC Codes and Packages
Each Suflave 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 |
|---|---|---|---|
| 24338-0550-01 | kit | kit of 1 kit | Azurity Pharmaceuticals, Inc. |
| 52268-0550-01 | kit | kit of 1 kit | Braintree Laboratories, Inc. |
| 52268-0550-01 | kit | kit of 1 kit | Braintree Laboratories, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Suflave’s own FDA approval (NDA 215344) are listed, never a generic. Some codes belong to companies that repackage Suflave: it is the same medicine in a different package.
What a Generic Suflave Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Suflave 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 Suflave”. 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 Suflave
Is there a generic for Suflave right now?
No. As of October 9, 2026 no generic magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, and sodium sulfate is listed for sale in the FDA NDC Directory.
When will Suflave go generic?
June 2044 is the expected month, and that is probable but not certain. It is when Suflave’s patents 12,239,659, 12,433,914, 12,594,298 and 12,290,529 end. They cover a way of using it and the product’s formulation, and once they end, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to August 2044, but it covers the product’s formulation, not the medicine itself, which a generic can often work around or challenge.
Will generic magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, and sodium sulfate be the same as Suflave?
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 $61.65 pharmacies pay each for Suflave today to about $34.52. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Suflave?
Not yet. The FDA Orange Book lists no approved generic version of Suflave.
When does the Suflave patent expire?
The FDA Orange Book lists 4 patents for Suflave; the last runs to August 2044. The one behind the expected month is patents 12,239,659, 12,433,914, 12,594,298 and 12,290,529, which end in June 2044. 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 (June 2044) weighs all of that.
Has anyone challenged the Suflave patents?
Yes. The first patent challenge to Suflave reached the FDA in April 2025, from one company 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 Suflave cost now?
Pharmacies paid about $61.65 each for Suflave powder in October 2026, 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 June 2044 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
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- MultaqDronedarone HydrochlorideJanuary to June 2029
- UpneeqOxymetazoline HydrochlorideAugust 2031
- ZycuboCopper HistidinateMarch 2042
About Suflave
- Generic name magnesium sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, and sodium sulfate
- How it is taken By mouth
- Company Azurity Pharmaceuticals Inc
- Patent challenges Since April 2025 (FDA)
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Suflave
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.