Pedmark Generic: When Will Generic Sodium Thiosulfate 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
Pedmark Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2033 About 7 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? July 2039 7 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 sodium thiosulfate is expected to be available in September 2033, about 7 years away. None is for sale yet.
Why September 2033?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it very likely: few things could still move it, but a court ruling or a new deal can.
If Pedmark’s last patent runs to July 2039, how can a generic come sooner?
The 7 patents that run past the expected month, to July 2039 (10,596,190, 11,291,728, 11,510,984, 11,617,793 and 3 more), cover a way of using it and 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. Here, a settlement between the companies sets the date. Generic companies have been challenging Pedmark’s patents with the FDA since October 2022. 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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. See the price pattern
What should I do now?
Keep taking Pedmark 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.
Pedmark 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
- Very likely Few things could still move it, but a court ruling or a new deal can.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- $50M a yearSmaller seller
- FDA approved 2022 September 2022 FDA Orange Book
- Patents listed 7 last runs to July 2039 A generic is expected sooner, in September 2033. See why FDA Orange Book
- Medicaid prescriptions 42 in the last four reported quarters, $179.4K CMS Medicaid drug utilization, to Q1 2026
Pedmark’s Road to a Generic
Pedmark has had the market to itself since the FDA approved it in September 2022 (Fennec Pharmaceuticals Inc). Its FDA protection (orphan drug) runs to September 2029. Its 7 listed patents run to July 2039. Generic companies have challenged its patents with the FDA since October 2022.
The first generic of Pedmark is expected in September 2033.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is about 6 years before the last listed patent runs out, in July 2039.
Why a Generic Can Come Before July 2039
The last listed patent runs to July 2039, but it covers a way of using it and 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.
Pedmark Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Pedmark’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 |
|---|---|---|---|
| 10,596,190 | A way of using it (U-3443) | January 2038 | Active delisting requested |
| 11,291,728 | The product’s formulation | July 2039 | Active |
| 11,510,984 | The product’s formulation | July 2039 | Active |
| 11,617,793 | The product’s formulation | July 2039 | Active |
| 11,964,018 | A way of using it (U-3898) | July 2039 | Active |
| 11,992,530 | A way of using it (U-3948) | July 2039 | Active |
| 11,998,604 | A way of using it (U-3952) | July 2039 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-384 | Seven years of protection for a use in a rare disease. | September 2029 | Active |
Source: FDA Orange Book, application 212937. Patent numbers open the patent on Google Patents.
Patent Challenges to Pedmark
The first patent challenge to Pedmark reached the FDA in October 2022, 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 Pedmark’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 injection, 12.5 g/100 mL | October 2022 | 1 company | No decision yet | Not yet | Not yet | July 2039 |
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 Sodium Thiosulfate
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
One company has applied to the FDA to make generic sodium thiosulfate.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for this one yet, so the company is 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 Pedmark’s patents with the FDA since October 2022: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic sodium thiosulfate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic sodium thiosulfate 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).
Pedmark 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 Pedmark, 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 Pedmark
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
42 prescriptions in the four quarters to Q1 2026, $179.4K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 25 | $5,547 |
| Q4 2025 | 17 | $173,896 |
| Q3 2025 | 0 | $0 |
| Q2 2025 | 0 | $0 |
| Q1 2025 | 0 | $0 |
Source: CMS Medicaid State Drug Utilization Data, over Pedmark’s own package codes.
Pedmark Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 12.5GM/100ML (125MG/ML) | Solution | Intravenous | September 2022 | Prescription reference product |
Source: FDA Orange Book, Fennec Pharmaceuticals Inc. Listed for sale today by Fennec Pharmaceuticals Inc. (FDA NDC Directory).
Pedmark NDC Codes and Packages
Each Pedmark 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 |
|---|---|---|---|
| 73077-0010-01 | SODIUM THIOSULFATE 12.5 g/100mL injection, solution | vial of 100 mL | Fennec Pharmaceuticals Inc. |
| 73077-0010-01 | SODIUM THIOSULFATE 12.5 g/100mL injection, solution | vial of 100 mL | Fennec Pharmaceuticals Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Pedmark’s own FDA approval (NDA 212937) are listed, never a generic. Some codes belong to companies that repackage Pedmark: it is the same medicine in a different package.
What a Generic Pedmark Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Pedmark 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 Pedmark”. 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 Pedmark
Is there a generic for Pedmark right now?
No. As of October 9, 2026 no generic sodium thiosulfate is listed for sale in the FDA NDC Directory.
When will Pedmark go generic?
September 2033 is the expected month, and that is very likely 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 July 2039, but it covers a way of using it and the product’s formulation, not the medicine itself, which a generic can often work around or challenge.
Will generic sodium thiosulfate be the same as Pedmark?
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. One company has applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 31% less once one company sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Pedmark?
Not yet. The FDA Orange Book lists no approved generic version of Pedmark.
When does the Pedmark patent expire?
The FDA Orange Book lists 7 patents for Pedmark; the last runs to July 2039. 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 (September 2033) weighs all of that.
Has anyone challenged the Pedmark patents?
Yes. The first patent challenge to Pedmark reached the FDA in October 2022, 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.
Changes to This Projection
- First generic expected September 2033 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
- VentavisIloprostJuly to December 2026
- NexplanonEtonogestrel2028 to 2029
- IncivekTelaprevirMay 2028
- DefitelioDefibrotide SodiumJune 2032
- AgamreeVamoroloneApril 2034
- RozlytrekEntrectinibFebruary 2035
About Pedmark
- Generic name sodium thiosulfate
- How it is taken Into a vein (IV)
- Company Fennec Pharmaceuticals Inc
- Patent challenges Since October 2022 (FDA)
- More drugs Brand-name drugs starting with P
- Have a question? A pharmacist answers, free. Ask about Pedmark
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.