Question 1

Is there a generic for Levacetylleucine?

Accepted Answer

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

Question 2

What is the reference-listed drug for Levacetylleucine?

Accepted Answer

AQNEURSA (NDA 219132, INTRABIO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Levacetylleucine?

Accepted Answer

The Orange Book lists 3 patents against Levacetylleucine products, with the earliest listed expiry in 2037. 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 Levacetylleucine have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Levacetylleucine. 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 Levacetylleucine are approved?

Accepted Answer

Levacetylleucine is approved in the following dosage form: for suspension.

Patent	Expires	In	Type
11400067	Apr 19, 2037	in 11 yr	U-4170
12433862	Apr 19, 2037	in 11 yr	U-4284
12433863	Apr 19, 2037	in 11 yr	U-4285

Levacetylleucine

Brand (NDA) products · for suspension

Marketing exclusivity (2)

Listed patents (3)

Levacetylleucine — frequently asked questions

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