Velphoro Generic: When Will Generic Ferric Oxyhydroxide Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Velphoro Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? During 2026 Sometime that year Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the last patent end? May 2035 11 patents listed with the FDA Why is a generic expected sooner?
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic ferric oxyhydroxide is expected to be available sometime in 2026. None is for sale yet.

Why 2026?

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 Velphoro’s last patent runs to May 2035, how can a generic come sooner?

The 11 patents that run past the expected month, to May 2035 (10,682,376, 10,695,367, 10,925,896, 10,925,897 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. Its FDA protection (pediatric) also runs past the expected month, to January 2028. That protection covers only the use it was granted for, so a generic may be able to launch for other uses and leave that one off its label. Here, a settlement between the companies sets the date. 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. 4 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $17.11 pharmacies pay per tablet for Velphoro today to about $4.62. See the price estimate

What should I do now?

Keep taking Velphoro 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.

Velphoro 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
Strong 4 companies have filed
Brand sales
Sales not reported
  • FDA approved 2013 November 2013 FDA Orange Book
  • Patents listed 11 last runs to May 2035 A generic is expected sooner, sometime in 2026. See why FDA Orange Book
  • Pharmacies pay $17.11 per tablet, up 0.2% in a year NADAC, October 2026
  • Medicare Part D spent $1.3M in 2025, for 302 people CMS Part D Spending by Drug
  • Medicaid prescriptions 25.1K in the last four reported quarters, $44.4M CMS Medicaid drug utilization, to Q1 2026

Velphoro’s Road to a Generic

Velphoro has had the market to itself since the FDA approved it in November 2013 (Vifor Fresenius Medical Care Renal Pharma France). Its FDA protection (pediatric) runs to January 2028. Its 11 listed patents run to May 2035.

The first generic of Velphoro is expected sometime in 2026.

Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.

Brand alone on the market Since FDA approval, November 2013
New patient population Ends July 2027
Pediatric Ends January 2028
Patent 10,682,376 Expires May 2029, with the pediatric extension
Patent 10,695,367 Expires May 2029, with the pediatric extension
Patent 9,561,251 Expires July 2030, with the pediatric extension
Patent 10,624,855 Expires May 2035, with the pediatric extension
Patent 11,234,938 Expires May 2035, with the pediatric extension
Patent 11,446,252 Expires May 2035, with the pediatric extension
Brand alone on the market FDA exclusivity Patent on the formulation Pediatric extension (six months) First generic expected 5 more patents end earlier; every patent is in the table below. Swipe the chart sideways to see every year.

Why a Generic Can Come Before May 2035

The last listed patent runs to May 2035, 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.

Velphoro Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Velphoro’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.

Patents listed with the FDA (11)
PatentWhat it coversProtects untilStatus
10,682,376 The product’s formulation May 2029 with the pediatric extension Active
10,695,367 The product’s formulation May 2029 with the pediatric extension Active
10,925,896 The product’s formulation May 2029 with the pediatric extension Active
10,925,897 The product’s formulation May 2029 with the pediatric extension Active
10,933,090 The product’s formulation May 2029 with the pediatric extension Active
11,013,761 The product’s formulation May 2029 with the pediatric extension Active
11,013,762 The product’s formulation May 2029 with the pediatric extension Active
9,561,251 The product’s formulation; a way of using it (U-1468) July 2030 with the pediatric extension Active
10,624,855 The product’s formulation May 2035 with the pediatric extension Active
11,234,938 The product’s formulation May 2035 with the pediatric extension Active
11,446,252 The product’s formulation May 2035 with the pediatric extension Active
FDA exclusivities (2)
ExclusivityWhat it meansEndsStatus
New patient population NPPThree years of protection for a newly approved group of patients.July 2027Active
Pediatric PEDSix more months, earned by studying the medicine in children.January 2028Active

Source: FDA Orange Book, application 205109. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Ferric Oxyhydroxide

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.

1

Applied to the FDA

4 companies have applied to the FDA to make generic ferric oxyhydroxide.

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.

2

Approved by the FDA

Not yet. The FDA has not approved a generic ferric oxyhydroxide. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic ferric oxyhydroxide 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).

Velphoro Price: What Pharmacies Pay and What Generics Usually Do

What Pharmacies Pay for Velphoro 500 mg chewable tab

$17.11 per tablet in October 2026, up 0.2% from a year earlier.

Hover over or tap anywhere on the chart to see that month’s price.

See the numbers
MonthPharmacies paid per tablet
October 2026$17.11
September 2026$17.11
August 2026$17.11
July 2026$17.11
June 2026$17.11
May 2026$17.11
April 2026$17.11
March 2026$17.11
February 2026$17.11
January 2026$17.11
February 2024$17.07
January 2024$17.05

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

What Pharmacies Pay for Velphoro Today$17.11per tablet · October 2026
Our Estimate for Generic Velphoroabout $4.62per tablet once generics reach pharmacies, about 73% less than today

How we estimate it. We start from what pharmacies pay for Velphoro today: $17.11 per tablet for Velphoro 500 mg chewable tab 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). Velphoro has 4 companies lined up, so our estimate uses the figure for four companies. More companies would bring the price lower; fewer, less of a drop.

Dollar figures apply FDA’s median drops to the $17.11 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 Velphoro

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 Velphoro, before manufacturer rebates.

$183.5K
January to March 2026, the latest CMS has posted
For 54 people, about $2,158 per prescription fill
$1.3M
2025, the whole year
For 302 people, about $2,007 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$183,46554$2,158.41
2025$1,254,295302$2,006.87

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Velphoro only, so no generic is counted in it. What CMS says it is used for: Sucroferric oxyhydroxide is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced.

Medicaid Prescriptions by Quarter

25,138 prescriptions in the four quarters to Q1 2026, $44.4M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 20265,552$10,574,681
Q4 20256,623$12,348,668
Q3 20256,765$12,253,706
Q2 20256,198$9,245,995
Q1 202510,502$11,818,106

Source: CMS Medicaid State Drug Utilization Data, over Velphoro’s own package codes.

Velphoro Strengths and Forms

StrengthFormHow it is takenApprovedStatus
EQ 500MG IRONTablet, chewableOralNovember 2013Prescription reference product

Source: FDA Orange Book, Vifor Fresenius Medical Care Renal Pharma France. Listed for sale today by Fresenius Medical Care North America and Fresenius Medical Care Renal Therapies Group, LLC (FDA NDC Directory).

Velphoro NDC Codes and Packages

Each Velphoro 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.

Velphoro packages (2)
NDCProductPackageCompany
49230-0645-51FERRIC OXYHYDROXIDE 500 mg/1 tablet, chewablebottle of 90 tabletsFresenius Medical Care Renal Therapies Group, LLC
49230-0645-51FERRIC OXYHYDROXIDE 500 mg/1 tablet, chewablebottle of 90 tabletsFresenius Medical Care Renal Therapies Group, LLC

Source: the FDA NDC Directory, current listings only. Only packages sold under Velphoro’s own FDA approval (NDA 205109) are listed, never a generic. Some codes belong to companies that repackage Velphoro: it is the same medicine in a different package.

What a Generic Velphoro Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Velphoro 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 Velphoro”. 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 Velphoro

Is there a generic for Velphoro right now?

No. As of October 9, 2026 no generic ferric oxyhydroxide is listed for sale in the FDA NDC Directory.

When will Velphoro go generic?

Sometime in 2026 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 May 2035, 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 ferric oxyhydroxide be the same as Velphoro?

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. 4 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $17.11 pharmacies pay per tablet for Velphoro today to about $4.62. That is a pattern from past launches, not a prediction for this one.

Has the FDA approved a generic Velphoro?

Not yet. The FDA Orange Book lists no approved generic version of Velphoro.

When does the Velphoro patent expire?

The FDA Orange Book lists 11 patents for Velphoro; the last runs to May 2035, counting a six-month pediatric extension. 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 (Sometime in 2026) weighs all of that.

How much does Velphoro cost now?

Pharmacies paid about $17.11 per tablet for Velphoro 500 mg chewable tab 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 Sometime in 2026 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

All upcoming generics

About Velphoro

  • Generic name ferric oxyhydroxide
  • How it is taken By mouth
  • Company Vifor Fresenius Medical Care Renal Pharma France
  • Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
  • More drugs Brand-name drugs starting with V
  • Have a question? A pharmacist answers, free. Ask about Velphoro

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, 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.