Acthar Generic: When Will Generic Corticotropin 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
Acthar Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? Not yet None in the FDA’s records yet
- When does the brand’s protection end? None listed No patent or exclusivity on file
- Can you buy a generic today? Not yet No company lists one for sale
There is no expected month yet for generic corticotropin. None is for sale yet.
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 Acthar 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.
Acthar 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
- Not rated Too early to rate.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- Patents listed 0 none listed FDA Orange Book
- Medicare Part D spent $285.8M in 2025, for 604 people CMS Part D Spending by Drug
Who Is Lined Up to Make Generic Corticotropin
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 Acthar yet.
Approved by the FDA
Not yet. The FDA has not approved a generic corticotropin. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic corticotropin 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).
Acthar 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 Acthar, 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 Acthar
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 Acthar, before manufacturer rebates.
- $51.1M
- January to March 2026, the latest CMS has posted
For 318 people, about $74,212 per prescription fill - $285.8M
- 2025, the whole year
For 604 people, about $72,495 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $51,057,904 | 318 | $74,212.07 |
| 2025 | $285,848,065 | 604 | $72,495.07 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Acthar only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain type of seizure in children (infantile spasms). This medication is also used to treat conditions such as multiple sclerosis, arthritis, lupus, eye conditions, skin/kidney/lung diseases, and immune system disorders.
Acthar Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 25 UNITS/VIAL | Injectable | Injection | Approved Prior to Jan 1, 1982 | Discontinued |
| 40 UNITS/VIAL | Injectable | Injection | Approved Prior to Jan 1, 1982 | Discontinued |
Source: FDA Orange Book, Sanofi Aventis US LLC.
What a Generic Acthar Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Acthar 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 Acthar”. 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 Acthar
Is there a generic for Acthar right now?
No. As of October 9, 2026 no generic corticotropin is listed for sale in the FDA NDC Directory.
When will Acthar go generic?
There is no expected month yet. 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 corticotropin be the same as Acthar?
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 Acthar?
Not yet. The FDA Orange Book lists no approved generic version of Acthar.
When does the Acthar patent expire?
No patents are listed for Acthar in the FDA Orange Book. 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.
Changes to This Projection
- First generic expected a date that is not known yet 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
- BelsomraSuvorexantNovember 2029
- TafinlarDabrafenib MesylateJuly 2030
- ExxuaGepirone HydrochlorideSeptember 2030
- ParsabivEtelcalcetide2033 to 2034
- XhanceFluticasone PropionateFebruary 2036
- KyzatrexTestosterone UndecanoateOctober 2041
About Acthar
- Generic name corticotropin
- How it is taken Injection into a muscle or injection under the skin
- Company Sanofi Aventis US LLC
- 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 A
- Have a question? A pharmacist answers, free. Ask about Acthar
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.