Question 1

Is there a generic for Artesunate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Artesunate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Artesunate?

Accepted Answer

ARTESUNATE (NDA 213036, AMIVAS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Artesunate?

Accepted Answer

The Orange Book lists 2 patents against Artesunate products, with the earliest listed expiry in 2044. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Artesunate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Artesunate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Artesunate are approved?

Accepted Answer

Artesunate is approved in the following dosage form: powder.

Patent	Expires	In	Type
12390442	Feb 16, 2044	in 17 yr 11 mo	U-4433
12121506	Feb 16, 2044	in 17 yr 11 mo	Product

Artesunate

Brand (NDA) products · powder

Marketing exclusivity (1)

Listed patents (2)

Artesunate — frequently asked questions

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