Zilbrysq Generic: When Will Generic Zilucoplan 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
Zilbrysq Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? October 2039 About 13 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? June 2035 9 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic zilucoplan sodium is expected to be available in October 2039, about 13 years away. None is for sale yet.
Why October 2039?
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early. We rate it probable: more likely than not, but it can still move.
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 Zilbrysq 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.
Zilbrysq by the Numbers
- Reason
- Not yet clearNo generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $212M a yearBig seller
- FDA approved 2023 October 2023 FDA Orange Book
- Patents listed 9 last runs to June 2035 FDA Orange Book
- Medicare Part D spent $125.4M in 2025, for 395 people CMS Part D Spending by Drug
- Medicaid prescriptions 15 in the last four reported quarters, $489.1K CMS Medicaid drug utilization, to Q1 2026
Zilbrysq’s Road to a Generic
Zilbrysq has had the market to itself since the FDA approved it in October 2023 (Ucb Inc). Its FDA protection (orphan drug) runs to October 2030. Its 9 listed patents run to June 2035.
The first generic of Zilbrysq is expected in October 2039.
No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
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.
Zilbrysq Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Zilbrysq’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 |
|---|---|---|---|
| 10,106,579 | The active ingredient; the product’s formulation; a way of using it (U-3735) | June 2035 | Active |
| 10,208,089 | The active ingredient; a way of using it (U-3735) | June 2035 | Active |
| 10,435,438 | The active ingredient; a way of using it (U-3735) | June 2035 | Active |
| 10,562,934 | The active ingredient | June 2035 | Active |
| 10,835,574 | The product’s formulation | June 2035 | Active |
| 11,014,965 | The active ingredient; a way of using it (U-3735) | June 2035 | Active |
| 11,535,650 | The product’s formulation | June 2035 | Active |
| 11,752,190 | The product’s formulation; a way of using it (U-3735) | June 2035 | Active |
| 11,965,040 | The product’s formulation | June 2035 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | October 2028 | Active |
| Orphan drug ODE-446 | Seven years of protection for a use in a rare disease. | October 2030 | Active |
Source: FDA Orange Book, application 216834. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Zilucoplan sodium
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 Zilbrysq yet.
Approved by the FDA
Not yet. The FDA has not approved a generic zilucoplan sodium. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic zilucoplan sodium 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).
Zilbrysq 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 Zilbrysq, 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 Zilbrysq
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 Zilbrysq, before manufacturer rebates.
- $43.9M
- January to March 2026, the latest CMS has posted
For 371 people, about $43,125 per prescription fill - $125.4M
- 2025, the whole year
For 395 people, about $40,779 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $43,901,189 | 371 | $43,124.94 |
| 2025 | $125,394,092 | 395 | $40,778.57 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Zilbrysq only, so no generic is counted in it. What CMS says it is used for: Zilucoplan is used to treat a certain muscle condition (generalized myasthenia gravis). It may help to improve symptoms of muscle weakness.
Medicaid Prescriptions by Quarter
15 prescriptions in the four quarters to Q1 2026, $489.1K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 15 | $489,058 |
| Q4 2025 | 0 | $0 |
| Q3 2025 | 0 | $0 |
| Q2 2025 | 0 | $0 |
| Q1 2025 | 0 | $0 |
Source: CMS Medicaid State Drug Utilization Data, over Zilbrysq’s own package codes.
Zilbrysq Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | Solution | Subcutaneous | October 2023 | Prescription reference product |
| EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | Solution | Subcutaneous | October 2023 | Prescription reference product |
| EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | Solution | Subcutaneous | October 2023 | Prescription reference product |
Source: FDA Orange Book, Ucb Inc. Listed for sale today by UCB, Inc. (FDA NDC Directory).
Zilbrysq NDC Codes and Packages
Each Zilbrysq 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 |
|---|---|---|---|
| 50474-0990-80 | ZILUCOPLAN 40 mg/mL injection, solution | box of 4 cartons of 7 syringes of .416 mL | UCB, Inc. |
| 50474-0991-80 | ZILUCOPLAN 40 mg/mL injection, solution | box of 4 cartons of 7 syringes of .574 mL | UCB, Inc. |
| 50474-0991-80 | ZILUCOPLAN 40 mg/mL injection, solution | box of 4 cartons of 7 syringes of .574 mL | UCB, Inc. |
| 50474-0992-80 | ZILUCOPLAN 40 mg/mL injection, solution | box of 4 cartons of 7 syringes of .81 mL | UCB, Inc. |
| 50474-0992-80 | ZILUCOPLAN 40 mg/mL injection, solution | box of 4 cartons of 7 syringes of .81 mL | UCB, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Zilbrysq’s own FDA approval (NDA 216834) are listed, never a generic. Some codes belong to companies that repackage Zilbrysq: it is the same medicine in a different package.
What a Generic Zilbrysq Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Zilbrysq 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 Zilbrysq”. 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 Zilbrysq
Is there a generic for Zilbrysq right now?
No. As of October 9, 2026 no generic zilucoplan sodium is listed for sale in the FDA NDC Directory.
When will Zilbrysq go generic?
October 2039 is the expected month, and that is probable but not certain. No generic application is on record yet. The month follows the patents and protections on record, which a challenge or a deal can end early.
Will generic zilucoplan sodium be the same as Zilbrysq?
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 Zilbrysq?
Not yet. The FDA Orange Book lists no approved generic version of Zilbrysq.
When does the Zilbrysq patent expire?
The FDA Orange Book lists 9 patents for Zilbrysq; the last runs to June 2035. 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 2039) weighs all of that.
Changes to This Projection
- First generic expected October 2039 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
- Arymo ERMorphine Sulfate2026 to 2027
- EmerphedEphedrine Sulfate2027 to 2028
- SpinrazaNusinersen2033 to 2034
- VyleesiBremelanotide AcetateNovember 2033
- JoenjaLeniolisib PhosphateJuly 2036
- Onyda XRClonidine HydrochlorideJuly 2041
About Zilbrysq
- Generic name zilucoplan sodium
- How it is taken Injection under the skin
- Company Ucb Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with Z
- Have a question? A pharmacist answers, free. Ask about Zilbrysq
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.