Question 1

Is there a generic for Lurbinectedin?

Accepted Answer

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

Question 2

What is the reference-listed drug for Lurbinectedin?

Accepted Answer

ZEPZELCA (NDA 213702, JAZZ) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Lurbinectedin?

Accepted Answer

The Orange Book lists 4 patents against Lurbinectedin products, with the earliest listed expiry in 2029. 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 Lurbinectedin have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Lurbinectedin is approved in the following dosage form: powder.

Patent	Expires	In	Type
7763615	Dec 13, 2029	in 3 yr 6 mo	SubstanceProductU-4299
12324806	May 29, 2040	in 14 yr 2 mo	U-4212
12433890	May 29, 2040	in 14 yr 2 mo	U-4305
12440490	May 29, 2040	in 14 yr 2 mo	U-4252

Lurbinectedin

Brand (NDA) products · powder

Marketing exclusivity (2)

Listed patents (4)

Lurbinectedin — frequently asked questions

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