Procysbi Generic: When Will Generic Cysteamine 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
Procysbi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? March 2030 About 3.5 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? February 2037 12 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 cysteamine bitartrate is expected to be available in March 2030, about 3.5 years away, first for Procysbi capsules. None is for sale yet. Each product has its own month below.
Why March 2030?
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 Procysbi’s last patent runs to February 2037, how can a generic come sooner?
The 6 patents that run past the expected month, to February 2037 (9,173,851, 9,233,077, 10,143,665, 10,328,037 and 2 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. Here, a settlement between the companies sets the date. Generic companies have been challenging Procysbi’s patents with the FDA since May 2020. 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. See the price pattern
What should I do now?
Keep taking Procysbi 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
- capsulesMarch 2030Probable · settlement between companies
- granules2031 to 2032Probable · settlement expected
Our month is only an estimate based on available information, so we never name a day.
Procysbi 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
- Moderate 2 companies have filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2013 April 2013 FDA Orange Book
- Patents listed 12 last runs to February 2037 A generic is expected sooner, in March 2030. See why FDA Orange Book
- Medicare Part D spent $40.9M in 2025, for 55 people CMS Part D Spending by Drug
- Medicaid prescriptions 444 in the last four reported quarters, $30.7M CMS Medicaid drug utilization, to Q1 2026
Procysbi’s Road to a Generic
Procysbi has had the market to itself since the FDA approved it in April 2013 (Horizon Therapeutics USA Inc). Its 12 listed patents run to February 2037. Generic companies have challenged its patents with the FDA since May 2020.
The first generic of Procysbi is expected in March 2030.
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 7 years before the last listed patent runs out, in February 2037.
Why a Generic Can Come Before February 2037
The last listed patent runs to February 2037, 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.
Procysbi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Procysbi’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 |
|---|---|---|---|
| 9,192,590 | A way of using it (U-1399) | July 2027 with the pediatric extension | Active |
| 9,198,882 | A way of using it (U-1399) | July 2027 with the pediatric extension | Active |
| 9,925,156 | The active ingredient; the product’s formulation; a way of using it (U-1399) | July 2027 with the pediatric extension | Active |
| 9,925,157 | The active ingredient; the product’s formulation; a way of using it (U-1399) | July 2027 with the pediatric extension | Active |
| 9,925,158 | The active ingredient; the product’s formulation; a way of using it (U-1399) | July 2027 with the pediatric extension | Active |
| 8,026,284 | A way of using it (U-1399) | March 2028 with the pediatric extension | Active |
| 9,173,851 | The product’s formulation | December 2034 with the pediatric extension | Active |
| 9,233,077 | The product’s formulation | December 2034 with the pediatric extension | Active |
| 10,143,665 | A way of using it (U-1399) | February 2037 with the pediatric extension | Active |
| 10,328,037 | A way of using it (U-1399) | February 2037 with the pediatric extension | Active |
| 10,548,859 | A way of using it (U-1399) | February 2037 with the pediatric extension | Active |
| 10,905,662 | A way of using it (U-1399) | February 2037 with the pediatric extension | Active |
Source: FDA Orange Book, application 203389, 213491. Patent numbers open the patent on Google Patents.
Patent Challenges to Procysbi
The first patent challenge to Procysbi reached the FDA in May 2020, from one company on that first day. The FDA’s list has 2 entries for Procysbi, by form and strength. 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 Procysbi’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 | |||||
| Delayed-release capsules, 25 mg and 75 mg | May 2020 | 1 company | Head start no longer applies decided March 2025 | Not yet | Not yet | August 2036 |
| Delayed-release granules, 75 mg/Packet and 300 mg/Packet | December 2021 | 1 company | No decision yet | Not yet | Not yet | August 2036 |
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 Cysteamine Bitartrate
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 cysteamine bitartrate.
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 Procysbi’s patents with the FDA since May 2020: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic cysteamine bitartrate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic cysteamine bitartrate 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).
Procysbi 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 Procysbi, 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 Procysbi
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 Procysbi, before manufacturer rebates.
- $9M
- January to March 2026, the latest CMS has posted
For 43 people, about $74,836 per prescription fill - $40.9M
- 2025, the whole year
For 55 people, about $75,635 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $8,980,298 | 43 | $74,835.82 |
| 2025 | $40,918,571 | 55 | $75,635.07 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Procysbi only, so no generic is counted in it. What CMS says it is used for: This medication is used to help preserve kidney function and manage kidney damage and other problems in people with an inherited disorder that causes build-up of a certain natural substance (cystine) in the body (nephropathic cystinosis).
Medicaid Prescriptions by Quarter
444 prescriptions in the four quarters to Q1 2026, $30.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 99 | $7,644,972 |
| Q4 2025 | 105 | $7,390,786 |
| Q3 2025 | 129 | $8,469,433 |
| Q2 2025 | 111 | $7,204,665 |
| Q1 2025 | 57 | $3,811,873 |
Source: CMS Medicaid State Drug Utilization Data, over Procysbi’s own package codes.
Procysbi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 25MG BASE | Capsule, delayed release | Oral | April 2013 | Prescription reference product |
| EQ 75MG BASE | Capsule, delayed release | Oral | April 2013 | Prescription reference product |
| EQ 300MG BASE/PACKET | Granule, delayed release | Oral | February 2020 | Prescription reference product |
| EQ 75MG BASE/PACKET | Granule, delayed release | Oral | February 2020 | Prescription reference product |
Source: FDA Orange Book, Horizon Therapeutics USA Inc. Listed for sale today by Horizon Therapeutics USA, Inc. (FDA NDC Directory).
Procysbi NDC Codes and Packages
Each Procysbi 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 |
|---|---|---|---|
| 75987-0100-04 | CYSTEAMINE BITARTRATE 25 mg/1 capsule, delayed release pellets | bottle of 60 capsules | Horizon Therapeutics USA, Inc. |
| 75987-0100-04 | CYSTEAMINE BITARTRATE 25 mg/1 capsule, delayed release pellets | bottle of 60 capsules | Horizon Therapeutics USA, Inc. |
| 75987-0145-13 | CYSTEAMINE BITARTRATE 300 mg/1 granule, delayed release | carton of 60 packets of 1 granule | Horizon Therapeutics USA, Inc. |
| 75987-0145-13 | CYSTEAMINE BITARTRATE 300 mg/1 granule, delayed release | carton of 60 packets of 1 granule | Horizon Therapeutics USA, Inc. |
| 75987-0145-14 | CYSTEAMINE BITARTRATE 300 mg/1 granule, delayed release | carton of 120 packets of 1 granule | Horizon Therapeutics USA, Inc. |
| 75987-0145-14 | CYSTEAMINE BITARTRATE 300 mg/1 granule, delayed release | carton of 120 packets of 1 granule | Horizon Therapeutics USA, Inc. |
| 75987-0101-08 | CYSTEAMINE BITARTRATE 75 mg/1 capsule, delayed release pellets | bottle of 250 capsules | Horizon Therapeutics USA, Inc. |
| 75987-0101-08 | CYSTEAMINE BITARTRATE 75 mg/1 capsule, delayed release pellets | bottle of 250 capsules | Horizon Therapeutics USA, Inc. |
Show the other 4 Procysbi packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 75987-0140-13 | CYSTEAMINE BITARTRATE 75 mg/1 granule, delayed release | carton of 60 packets of 1 granule | Horizon Therapeutics USA, Inc. |
| 75987-0140-13 | CYSTEAMINE BITARTRATE 75 mg/1 granule, delayed release | carton of 60 packets of 1 granule | Horizon Therapeutics USA, Inc. |
| 75987-0140-14 | CYSTEAMINE BITARTRATE 75 mg/1 granule, delayed release | carton of 120 packets of 1 granule | Horizon Therapeutics USA, Inc. |
| 75987-0140-14 | CYSTEAMINE BITARTRATE 75 mg/1 granule, delayed release | carton of 120 packets of 1 granule | Horizon Therapeutics USA, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Procysbi’s own FDA approval (NDA 203389, NDA 213491) are listed, never a generic. Some codes belong to companies that repackage Procysbi: it is the same medicine in a different package.
What a Generic Procysbi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Procysbi 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 Procysbi”. 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 Procysbi
Is there a generic for Procysbi right now?
No. As of October 9, 2026 no generic cysteamine bitartrate is listed for sale in the FDA NDC Directory.
When will Procysbi go generic?
March 2030 is the expected month, 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 February 2037, 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 cysteamine bitartrate be the same as Procysbi?
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. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Procysbi?
Not yet. The FDA Orange Book lists no approved generic version of Procysbi.
When does the Procysbi patent expire?
The FDA Orange Book lists 12 patents for Procysbi; the last runs to February 2037, 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 month on this page (March 2030) weighs all of that.
Has anyone challenged the Procysbi patents?
Yes. The first patent challenge to Procysbi reached the FDA in May 2020, 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 March 2030 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
- IzbaTravoprostDuring 2026
- EdarbyclorAzilsartan Kamedoxomil and Chlorthalidone2027 to 2028
- SirturoBedaquiline FumarateMarch 2029
- AponvieAprepitantJune 2032
- Voquezna Triple PakAmoxicillin, Clarithromycin, and Vonoprazan Fumarate2033 to 2034
- OleptroTrazodone HydrochlorideTBD no date yet
About Procysbi
- Generic name cysteamine bitartrate
- How it is taken By mouth
- Company Horizon Therapeutics USA Inc
- Patent challenges Since May 2020 (FDA)
- More drugs Brand-name drugs starting with P
- Have a question? A pharmacist answers, free. Ask about Procysbi
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.