Ferriprox Generic: When Will Generic Deferiprone 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
Ferriprox Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? October 2038 About 12 years away Why then?
- Has the FDA approved a generic? February 2019 3 companies approved
- When does the last patent end? October 2038 7 patents listed with the FDA
- Can you buy a generic today? Yes 5 companies list one
It already is. A generic deferiprone is listed for sale by 5 companies, so ask your pharmacy whether it can fill your prescription with one.
Why October 2038?
It is when Ferriprox’s patents 10,780,055, 10,940,115, 10,940,116, 11,357,731 and 2 more end. They cover the product’s formulation and a way of using it, and once they end, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Ferriprox, 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.
Ferriprox by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2011 October 2011 FDA Orange Book
- Patents listed 7 last runs to October 2038 FDA Orange Book
- Generics FDA-approved 3 companies, the first approved February 2019 FDA Orange Book
- Medicare Part D spent $3M in 2025, for 29 people CMS Part D Spending by Drug
- Medicaid prescriptions 2,342 in the last four reported quarters, $57.3M CMS Medicaid drug utilization, to Q1 2026
Ferriprox’s Road to a Generic
Ferriprox has had the market to itself since the FDA approved it in October 2011 (Chiesi USA Inc). Its FDA protection (orphan drug) runs to April 2028. Its 7 listed patents run to October 2038. Generic companies have challenged its patents with the FDA since January 2016.
The first generic of Ferriprox is expected in October 2038.
Why that month: patents 10,780,055, 10,940,115, 10,940,116, 11,357,731 and 2 more, on the product’s formulation and a way of using it, end then.
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.
Ferriprox Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Ferriprox’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 10,780,055, 10,940,115, 10,940,116, 11,357,731 and 2 more, which end in October 2038, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,703,156 | The product’s formulation; a way of using it (U-3083) | October 2029 | Active |
| 10,780,055 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3083) | October 2038 | Active |
| 10,940,115 Sets the expected month of generic availability | The product’s formulation; a way of using it (U-3083) | October 2038 | Active |
| 10,940,116 Sets the expected month of generic availability | The product’s formulation | October 2038 | Active |
| 11,357,731 Sets the expected month of generic availability | A way of using it (U-3083) | October 2038 | Active |
| 11,458,103 Sets the expected month of generic availability | The product’s formulation | October 2038 | Active |
| 11,723,874 Sets the expected month of generic availability | A way of using it (U-3083) | October 2038 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-417 | Seven years of protection for a use in a rare disease. | April 2028 | Active |
| Orphan drug ODE-418 | Seven years of protection for a use in a rare disease. | April 2028 | Active |
| Orphan drug ODE-419 | Seven years of protection for a use in a rare disease. | April 2028 | Active |
| Orphan drug ODE-420 | Seven years of protection for a use in a rare disease. | April 2028 | Active |
| Orphan drug ODE-421 | Seven years of protection for a use in a rare disease. | April 2028 | Active |
Source: FDA Orange Book, application 208030, 021825, 212269. Patent numbers open the patent on Google Patents.
Patent Challenges to Ferriprox
The first patent challenge to Ferriprox reached the FDA in January 2016, from one company on that first day. A first challenger began selling its generic in September 2020.
What Is a Patent Challenge?
A generic company that wants to sell its version before Ferriprox’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 | |||||
| Tablets, 500 mg | January 2016 | 1 company | First challenger eligible decided August 2019 | February 2019 | September 2020 | June 2021 |
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 Deferiprone
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
No application count is on record for Ferriprox, but the FDA has already approved 3 companies (step 2), and every approval starts with an application.
Generic companies have challenged Ferriprox’s patents with the FDA since January 2016: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 3 companies, the first in February 2019. 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 deferiprone is listed for sale by 5 companies. Ask your pharmacy whether it can fill your prescription with it.
AvKARE, DR. REDDY'S LABORATORIES, INC., Hikma Pharmaceuticals USA Inc., Sun Pharmaceutical Industries, Inc. and Taro Pharmaceuticals U.S.A., Inc.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Taro Pharmaceutical Industries Ltd | February 2019 | 1GM, 500MG | AB |
| Hikma Pharmaceuticals USA Inc | March 2021 | 1GM, 500MG | AB |
| Senores Pharmaceuticals Inc | December 2025 | 1GM, 500MG | AB |
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).
Ferriprox 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 Ferriprox, 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 Ferriprox
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 Ferriprox, before manufacturer rebates.
- $205.8K
- January to March 2026, the latest CMS has posted
About $15,834 per prescription fill - $3M
- 2025, the whole year
For 29 people, about $15,088 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $205,836 | – | $15,833.55 |
| 2025 | $2,987,494 | 29 | $15,088.36 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ferriprox only, so no generic is counted in it. What CMS says it is used for: This medication is used by people with certain blood disorders (such as thalassemia, sickle cell anemia) who have too much iron in the body, caused by repeated blood transfusions. Blood transfusions help people with blood disorders but they also bring extra iron into the body.
Medicaid Prescriptions by Quarter
2,342 prescriptions in the four quarters to Q1 2026, $57.3M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 569 | $14,462,245 |
| Q4 2025 | 578 | $14,122,781 |
| Q3 2025 | 638 | $15,569,491 |
| Q2 2025 | 557 | $13,098,822 |
| Q1 2025 | 530 | $12,180,436 |
Source: CMS Medicaid State Drug Utilization Data, over Ferriprox’s own package codes.
Ferriprox Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG/ML | Solution | Oral | September 2015 | Prescription reference product |
| 1GM | Tablet | Oral | July 2019 | Prescription reference product |
| 500MG | Tablet | Oral | October 2011 | Discontinued reference product |
| 80MG/ML | Solution | Oral | April 2018 | Discontinued reference product |
Source: FDA Orange Book, Chiesi USA Inc. Listed for sale today by Chiesi USA, Inc. and ApoPharma USA, Inc. (FDA NDC Directory).
Ferriprox NDC Codes and Packages
Each Ferriprox 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 |
|---|---|---|---|
| 52609-4502-07 | 100 mg/mL solution | bottle of 500 mL | ApoPharma USA, Inc. |
| 10122-0100-10 | 500 mg tablet, film coated | bottle of 100 tablets | Chiesi USA, Inc. |
| 10122-0101-50 | DEFERIPRONE 100 mg/mL solution | bottle of 500 mL | Chiesi USA, Inc. |
| 10122-0101-50 | DEFERIPRONE 100 mg/mL solution | bottle of 500 mL | Chiesi USA, Inc. |
| 10122-0104-01 | DEFERIPRONE 1000 mg/1 tablet | blister pack of 50 tablets | Chiesi USA, Inc. |
| 10122-0104-01 | DEFERIPRONE 1000 mg/1 tablet | blister pack of 50 tablets | Chiesi USA, Inc. |
| 10122-0104-05 | DEFERIPRONE 1000 mg/1 tablet | bottle of 50 tablets | Chiesi USA, Inc. |
| 10122-0104-05 | DEFERIPRONE 1000 mg/1 tablet | bottle of 50 tablets | Chiesi USA, Inc. |
| 10122-0103-05 | DEFERIPRONE 1000 mg/1 tablet, film coated | bottle of 50 tablets | Chiesi USA, Inc. |
| 10122-0103-05 | DEFERIPRONE 1000 mg/1 tablet, film coated | bottle of 50 tablets | Chiesi USA, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Ferriprox’s own FDA approval (NDA 208030, NDA 21825, NDA 212269) are listed, never a generic. Some codes belong to companies that repackage Ferriprox: it is the same medicine in a different package.
What a Generic Ferriprox 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 Ferriprox
Is there a generic for Ferriprox right now?
Yes. The FDA NDC Directory lists a generic deferiprone from 5 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Ferriprox go generic?
It already has. The FDA NDC Directory lists a generic deferiprone from 5 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic deferiprone be the same as Ferriprox?
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. The FDA has already approved 3 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Ferriprox?
Yes. The FDA Orange Book lists approved generic versions from 3 companies, the first approved in February 2019: Taro Pharmaceutical Industries Ltd, Hikma Pharmaceuticals USA Inc and Senores Pharmaceuticals 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 Ferriprox patent expire?
The FDA Orange Book lists 7 patents for Ferriprox; the last runs to October 2038. The one behind the expected month is patents 10,780,055, 10,940,115, 10,940,116, 11,357,731 and 2 more, which end in October 2038. 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 (October 2038) weighs all of that.
Has anyone challenged the Ferriprox patents?
Yes. The first patent challenge to Ferriprox reached the FDA in January 2016, from one company on that first day. A first challenger began selling its generic in September 2020. 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 October 2038 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
- Norepinephrine Bitartrate in DextroseDextrose and Norepinephrine Bitartrate2026 to 2027
- VerdesoDesonideNovember 2028
- DesmodaDesmopressin AcetateFebruary 2029
- RykindoRisperidoneApril 2032
- AkeegaAbiraterone Acetate and Niraparib TosylateJuly 2037
- InluriyoImlunestrantSeptember 2039
About Ferriprox
- Generic name deferiprone
- How it is taken By mouth
- Company Chiesi USA Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since January 2016 (FDA)
- More drugs Brand-name drugs starting with F
- Have a question? A pharmacist answers, free. Ask about Ferriprox
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, 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.