Question 1

Is there a generic for Delgocitinib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Delgocitinib?

Accepted Answer

ANZUPGO (NDA 219155, LEO PHARMA AS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Delgocitinib?

Accepted Answer

The Orange Book lists 1 patent against Delgocitinib products, with the earliest listed expiry in 2031. 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 Delgocitinib have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Delgocitinib is approved in the following dosage form: cream.

Delgocitinib

Brand (NDA) products · cream

Marketing exclusivity (1)

Listed patents (1)

Delgocitinib — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.