Question 1

Is there a generic for Afamelanotide?

Accepted Answer

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

Question 2

What is the reference-listed drug for Afamelanotide?

Accepted Answer

SCENESSE (NDA 210797, CLIVUNEL INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Afamelanotide?

Accepted Answer

The Orange Book lists 1 patent against Afamelanotide products, with the earliest listed expiry in 2033. 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 Afamelanotide have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Afamelanotide is approved in the following dosage form: implant.

Afamelanotide

Brand (NDA) products · implant

Marketing exclusivity (1)

Listed patents (1)

Afamelanotide — frequently asked questions

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