Fabhalta Generic: When Will Generic Iptacopan 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
Fabhalta Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? August 2038 About 12 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 2041 8 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 iptacopan hydrochloride is expected to be available in August 2038, about 12 years away. None is for sale yet.
Why August 2038?
It is when Fabhalta’s patent 11,723,901 ends. That patent covers a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Fabhalta’s last patent runs to July 2041, how can a generic come sooner?
The 4 patents that run past the expected month, to July 2041 (12,384,758, 11,603,363, 11,951,101 and 12,453,726), cover a way of using it, the active ingredient and the product’s formulation. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier 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, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Fabhalta 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.
Fabhalta by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $377M a yearBig seller
- FDA approved 2023 December 2023 FDA Orange Book
- Patents listed 8 last runs to July 2041 A generic is expected sooner, in August 2038. See why FDA Orange Book
- Medicare Part D spent $86.7M in 2025, for 263 people CMS Part D Spending by Drug
- Medicaid prescriptions 538 in the last four reported quarters, $24.9M CMS Medicaid drug utilization, to Q1 2026
Fabhalta’s Road to a Generic
Fabhalta has had the market to itself since the FDA approved it in December 2023 (Novartis Pharmaceuticals Corp). Its FDA protection (orphan drug) runs to March 2032. Its 8 listed patents run to July 2041.
The first generic of Fabhalta is expected in August 2038.
Why that month: patent 11,723,901, on a way of using it, ends then. That is about 3 years before the last listed patent runs out, in July 2041.
Why a Generic Can Come Before July 2041
The last listed patent runs to July 2041; a court ruling or a settlement can bring a generic sooner. 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.
Fabhalta Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Fabhalta’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: patent 11,723,901, which ends in August 2038, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,682,968 | The active ingredient; the product’s formulation | July 2034 | Active |
| 10,093,663 | A way of using it (U-4161, U-3980) | July 2034 | Active |
| 11,723,901 Sets the expected month of generic availability | A way of using it (U-3980) | August 2038 | Active |
| 12,285,422 | A way of using it (U-4181) | August 2038 | Active |
| 12,384,758 | A way of using it (U-3980, U-4161) | May 2041 | Active |
| 11,603,363 | The active ingredient; the product’s formulation | May 2041 | Active |
| 11,951,101 | A way of using it (U-3895) | July 2041 | Active |
| 12,453,726 | A way of using it (U-4300) | July 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-949 | Three years of protection for a newly approved use (indication). | August 2027 | Active |
| New use I-963 | Three years of protection for a newly approved use (indication). | March 2028 | Active |
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | December 2028 | Active |
| Orphan drug ODE-456 | Seven years of protection for a use in a rare disease. | December 2030 | Active |
| Orphan drug ODE-524 | Seven years of protection for a use in a rare disease. | March 2032 | Active |
Source: FDA Orange Book, application 218276. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Iptacopan Hydrochloride
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 company is recorded as having applied to the FDA to make a generic Fabhalta yet.
Approved by the FDA
Not yet. The FDA has not approved a generic iptacopan hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic iptacopan hydrochloride 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).
Fabhalta 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 Fabhalta, 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 Fabhalta
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 Fabhalta, before manufacturer rebates.
- $29.7M
- January to March 2026, the latest CMS has posted
For 258 people, about $47,569 per prescription fill - $86.7M
- 2025, the whole year
For 263 people, about $46,385 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $29,682,922 | 258 | $47,568.79 |
| 2025 | $86,740,474 | 263 | $46,385.28 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Fabhalta only, so no generic is counted in it. What CMS says it is used for: Iptacopan is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria - PNH). This disorder causes your body's immune system to break down red blood cells, which results in anemia.
Medicaid Prescriptions by Quarter
538 prescriptions in the four quarters to Q1 2026, $24.9M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 166 | $7,737,363 |
| Q4 2025 | 154 | $7,057,221 |
| Q3 2025 | 140 | $6,504,629 |
| Q2 2025 | 78 | $3,610,061 |
| Q1 2025 | 30 | $1,389,009 |
Source: CMS Medicaid State Drug Utilization Data, over Fabhalta’s own package codes.
Fabhalta Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 200MG BASE | Capsule | Oral | December 2023 | Prescription reference product |
Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Fabhalta NDC Codes and Packages
Each Fabhalta 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 |
|---|---|---|---|
| 00078-1189-20 | IPTACOPAN HYDROCHLORIDE 200 mg/1 capsule | bottle of 60 capsules | Novartis Pharmaceuticals Corporation |
| 00078-1189-20 | IPTACOPAN HYDROCHLORIDE 200 mg/1 capsule | bottle of 60 capsules | Novartis Pharmaceuticals Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Fabhalta’s own FDA approval (NDA 218276) are listed, never a generic. Some codes belong to companies that repackage Fabhalta: it is the same medicine in a different package.
What a Generic Fabhalta Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Fabhalta 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 Fabhalta”. 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 Fabhalta
Is there a generic for Fabhalta right now?
No. As of October 9, 2026 no generic iptacopan hydrochloride is listed for sale in the FDA NDC Directory.
When will Fabhalta go generic?
August 2038 is the expected month, and that is probable but not certain. It is when Fabhalta’s patent 11,723,901 ends. That patent covers a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to July 2041; a court ruling or a settlement can bring a generic sooner.
Will generic iptacopan hydrochloride be the same as Fabhalta?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Fabhalta?
Not yet. The FDA Orange Book lists no approved generic version of Fabhalta.
When does the Fabhalta patent expire?
The FDA Orange Book lists 8 patents for Fabhalta; the last runs to July 2041. The one behind the expected month is patent 11,723,901, which ends in August 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 (August 2038) weighs all of that.
Changes to This Projection
- First generic expected August 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
- VentavisIloprostJuly to December 2026
- DefitelioDefibrotide SodiumJune 2032
- AgamreeVamoroloneApril 2034
- NityrNitisinoneJanuary 2035
- IngrezzaValbenazine TosylateMarch 2038
- RyaltrisMometasone Furoate and Olopatadine HydrochlorideNovember 2044
About Fabhalta
- Generic name iptacopan hydrochloride
- How it is taken By mouth
- Company Novartis Pharmaceuticals Corp
- More drugs Brand-name drugs starting with F
- Have a question? A pharmacist answers, free. Ask about Fabhalta
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, 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.