Selenious Acid Generic: When Will Generic Selenious Acid 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
Selenious Acid Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? February 2025 6 companies approved
- When does the last patent end? July 2041 2 patents listed with the FDA
- Can you buy a generic today? Yes 1 company lists one
It already is. A generic selenious acid is listed for sale by 1 company, so ask your pharmacy whether it can fill your prescription with one.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Selenious Acid, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Selenious Acid 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
- Very strong 18 companies have filed, 11 first in line
- Brand sales
- $80M a yearSmaller seller
- FDA approved 2019 April 2019 FDA Orange Book
- Patents listed 2 last runs to July 2041 FDA Orange Book
- Generics FDA-approved 6 companies, the first approved February 2025 FDA Orange Book
- Medicaid prescriptions 16K in the last four reported quarters, $9.7M CMS Medicaid drug utilization, to Q1 2026
Selenious Acid’s Road to a Generic
Selenious Acid has had the market to itself since the FDA approved it in April 2019 (American Regent Inc). Its 2 listed patents run to July 2041. Generic companies have challenged its patents with the FDA since June 2024.
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
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.
Selenious Acid Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Selenious Acid’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 |
|---|---|---|---|
| 11,998,565 | The product’s formulation | July 2041 | Active |
| 12,150,957 | A way of using it (U-4039) | July 2041 | Active |
Source: FDA Orange Book, application 209379. Patent numbers open the patent on Google Patents.
Patent Challenges to Selenious Acid
The first patent challenge to Selenious Acid reached the FDA in June 2024, from 4 companies on that first day. The FDA’s list has 3 entries for Selenious Acid, by form and strength. The FDA approved a first challenger’s generic in February 2025, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Selenious Acid’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 | |||||
| Intravenous solution, 12 mcg/2 mL | June 2024 | 4 companies | First challenger eligible decided July 2025 | June 2025 | Not yet | July 2041 |
| Intravenous solution, 60 mcg/mL | June 2024 | 5 companies | No decision yet | Not yet | Not yet | July 2041 |
| Intravenous solution, 600 mcg/10 mL | June 2024 | 11 companies | First challenger eligible decided March 2025 | February 2025 | Not yet | July 2041 |
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 Selenious Acid
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
18 companies have applied to the FDA to make generic selenious acid.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 11 of them were first in line, all 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 Selenious Acid’s patents with the FDA since June 2024: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 6 companies, the first in February 2025. 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
Yes. A generic selenious acid is listed for sale by 1 company. Ask your pharmacy whether it can fill your prescription with it.
Gland Pharma Limited
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Sun Pharmaceutical Industries Ltd | February 2025 | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | AP |
| Aspiro Pharma Ltd | June 2025 | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML), EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | AP |
| Gland Pharma Ltd | July 2025 | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | AP |
| Stira Pharmaceuticals LLC | December 2025 | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML), EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | AP |
| Emerge Bioscience Pte Ltd | February 2026 | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | AP |
| Zydus Pharmaceuticals USA Inc | June 2026 | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML), EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML), EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | AP |
| Fresenius Kabi USA LLC discontinued | February 2025 | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | – |
| Cipla Ltd discontinued | July 2025 | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML), EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | – |
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).
Selenious Acid 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 Selenious Acid, 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 Selenious Acid
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.
Medicaid Prescriptions by Quarter
15,989 prescriptions in the four quarters to Q1 2026, $9.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 3,772 | $2,508,817 |
| Q4 2025 | 4,244 | $2,464,046 |
| Q3 2025 | 4,377 | $2,753,880 |
| Q2 2025 | 3,596 | $2,016,320 |
| Q1 2025 | 3,943 | $2,197,671 |
Source: CMS Medicaid State Drug Utilization Data, over Selenious Acid’s own package codes.
Selenious Acid Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | Solution | Intravenous | April 2019 | Prescription reference product |
| EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | Solution | Intravenous | January 2021 | Prescription reference product |
| EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | Solution | Intravenous | August 2021 | Prescription reference product |
Source: FDA Orange Book, American Regent Inc. Listed for sale today by American Regent, Inc. (FDA NDC Directory).
Selenious Acid NDC Codes and Packages
Each Selenious Acid 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 |
|---|---|---|---|
| 00517-6502-10 | SELENIUM 6 ug/mL injection, solution | box of 10 vials of 2 mL | American Regent, Inc. |
| 00517-6502-10 | SELENIUM 6 ug/mL injection, solution | box of 10 vials of 2 mL | American Regent, Inc. |
| 00517-6560-05 | SELENIUM 60 ug/mL injection, solution | box of 5 vials of 10 mL | American Regent, Inc. |
| 00517-6560-05 | SELENIUM 60 ug/mL injection, solution | box of 5 vials of 10 mL | American Regent, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Selenious Acid’s own FDA approval (NDA 209379) are listed, never a generic. Some codes belong to companies that repackage Selenious Acid: it is the same medicine in a different package.
What a Generic Selenious Acid Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Selenious Acid
Is there a generic for Selenious Acid right now?
Yes. The FDA NDC Directory lists a generic selenious acid from 1 company. Ask your pharmacy whether it can fill your prescription with it.
When will Selenious Acid go generic?
It already has. The FDA NDC Directory lists a generic selenious acid from 1 company, so ask your pharmacy whether it can fill your prescription with one.
Will generic selenious acid be the same as Selenious Acid?
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. 18 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Selenious Acid?
Yes. The FDA Orange Book lists approved generic versions from 6 companies, the first approved in February 2025: Sun Pharmaceutical Industries Ltd, Aspiro Pharma Ltd, Gland Pharma Ltd, Stira Pharmaceuticals LLC and 2 more. 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 Selenious Acid patent expire?
The FDA Orange Book lists 2 patents for Selenious Acid; the last runs to July 2041. 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 (a date that is not known yet) weighs all of that.
Has anyone challenged the Selenious Acid patents?
Yes. The first patent challenge to Selenious Acid reached the FDA in June 2024, from 4 companies on that first day. The FDA approved a first challenger’s generic in February 2025, and the list records no sale by a first challenger 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.
Changes to This Projection
- First generic expected a date that is not known yet 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
- Tobradex STDexamethasone and TobramycinAugust 2028
- ZecuitySumatriptan SuccinateOctober 2032
- BylvayOdevixibat2036 to 2037
- Lonhala MagnairGlycopyrrolateDecember 2036
- FrindovyxCyclophosphamideTBD no date yet
- PrestaliaAmlodipine Besylate and Perindopril ArginineTBD no date yet
About Selenious Acid
- Generic name selenious acid
- How it is taken Into a vein (IV)
- Company American Regent Inc
- Patent challenges Since June 2024 (FDA)
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Selenious Acid
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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.