Artesunate Generic: When Will Generic Artesunate 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

Artesunate Generic at a Glance

Four quick answers from FDA records and our estimate.

When is the first generic expected? February 2044 About 17.5 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 2044 2 patents listed with the FDA
Can you buy a generic today? Not yet No company lists one for sale

Dr. Brian Staiger Explains

PharmD, BCPS · Clinical pharmacist Updated October 9, 2026

Generic artesunate is expected to be available in February 2044, about 17.5 years away. None is for sale yet.

Why February 2044?

It is when Artesunate’s patents 12,121,506 and 12,390,442 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 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 Artesunate 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.

Artesunate 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: $21M a yearSmaller seller

FDA approved 2020 May 2020 FDA Orange Book
Patents listed 2 last runs to February 2044 FDA Orange Book

Artesunate’s Road to a Generic

Artesunate has had the market to itself since the FDA approved it in May 2020 (Amivas Inc). Its FDA protection (orphan drug) runs to May 2027. Its 2 listed patents run to February 2044.

The first generic of Artesunate is expected in February 2044.

Why that month: patents 12,121,506 and 12,390,442, on the product’s formulation and a way of using it, end then.

Brand alone on the market Since FDA approval, May 2020

Orphan drug Ends May 2027

Patent 12,121,506 Expires February 2044 The patent behind the expected month of generic availability

Patent 12,390,442 Expires February 2044 The patent behind the expected month of generic availability

Brand alone on the market FDA exclusivity Patent on the formulation Patent on a use First generic expected Swipe the chart sideways to see every year.

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.

Artesunate Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Artesunate’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 12,121,506 and 12,390,442, which end in February 2044, the month the first generic is expected.

Patents listed with the FDA (2)
Patent	What it covers	Protects until	Status
12,121,506 Sets the expected month of generic availability	The product’s formulation	February 2044	Active
12,390,442 Sets the expected month of generic availability	A way of using it (U-4433)	February 2044	Active

FDA exclusivities (1)
Exclusivity	What it means	Ends	Status
Orphan drug ODE-290	Seven years of protection for a use in a rare disease.	May 2027	Active

Source: FDA Orange Book, application 213036. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Artesunate

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 Artesunate yet.

Approved by the FDA

Not yet. The FDA has not approved a generic artesunate. Final approval often comes close to the day a generic can be sold.

For Sale in Pharmacies

Not yet. No company lists a generic artesunate 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).

Artesunate 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 Artesunate, 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).

Brandbefore generics

1 makerabout 31% less

2 makersabout 44% less

4 makersabout 73% less

6+ makersover 95% less

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.

Artesunate Strengths and Forms

Strength	Form	How it is taken	Approved	Status
110MG/VIAL	Powder	Intravenous	May 2020	Prescription reference product

Source: FDA Orange Book, Amivas Inc. Listed for sale today by Amivas, Inc (FDA NDC Directory).

Artesunate NDC Codes and Packages

Each Artesunate 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.

Artesunate packages (2)
NDC	Product	Package	Company
73607-0011-11	kit	2 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL * 1 SOLUTION in 1 VIAL	Amivas, Inc
73607-0011-11	kit	2 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL * 1 SOLUTION in 1 VIAL	Amivas, Inc

Source: the FDA NDC Directory, current listings only. Only packages sold under Artesunate’s own FDA approval (NDA 213036) are listed, never a generic. Some codes belong to companies that repackage Artesunate: it is the same medicine in a different package.

What a Generic Artesunate Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Artesunate 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 Artesunate”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.

Ask a pharmacist about Artesunate

Questions people ask about Artesunate

Is there a generic for Artesunate right now?

No. As of October 9, 2026 no generic artesunate is listed for sale in the FDA NDC Directory.

When will Artesunate go generic?

February 2044 is the expected month, and that is probable but not certain. It is when Artesunate’s patents 12,121,506 and 12,390,442 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.

Will generic artesunate be the same as Artesunate?

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 Artesunate?

Not yet. The FDA Orange Book lists no approved generic version of Artesunate.

When does the Artesunate patent expire?

The FDA Orange Book lists 2 patents for Artesunate; the last runs to February 2044. The one behind the expected month is patents 12,121,506 and 12,390,442, which end in February 2044. 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 (February 2044) weighs all of that.

Changes to This Projection

October 2026First generic expected February 2044 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

All upcoming generics

About Artesunate

Generic name artesunate
How it is taken Into a vein (IV)
Company Amivas Inc
More drugs Brand-name drugs starting with A
Have a question? A pharmacist answers, free. Ask about Artesunate

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, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.