Question 1

Is there a generic for Pegulicianine acetate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Pegulicianine acetate?

Accepted Answer

LUMISIGHT (NDA 214511, LUMICELL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Pegulicianine acetate?

Accepted Answer

The Orange Book lists 6 patents against Pegulicianine acetate products, with the earliest listed expiry in 2030. 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 Pegulicianine acetate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Pegulicianine acetate. 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 Pegulicianine acetate are approved?

Accepted Answer

Pegulicianine acetate is approved in the following dosage form: powder.

Patent	Expires	In	Type
11592396	Sep 01, 2030	in 4 yr 3 mo	Substance
9155471	Oct 12, 2031	in 5 yr 5 mo	U-3890
10285759	Dec 08, 2031	in 5 yr 7 mo	U-3890
9532835	Dec 08, 2031	in 5 yr 7 mo	U-3890
9032965	Dec 08, 2031	in 5 yr 7 mo	U-3890
9763577	Sep 14, 2034	in 8 yr 4 mo	SubstanceProductU-3890

Pegulicianine acetate

Brand (NDA) products · powder

Marketing exclusivity (1)

Listed patents (6)

Pegulicianine acetate — frequently asked questions

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