Question 1

Is there a generic for Flibanserin?

Accepted Answer

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

Question 2

What is the reference-listed drug for Flibanserin?

Accepted Answer

ADDYI (NDA 022526, SPROUT PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Flibanserin?

Accepted Answer

The Orange Book lists 1 patent against Flibanserin products, with the earliest listed expiry in 2028. 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 Flibanserin have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Flibanserin is approved in the following dosage form: tablet.

Flibanserin

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (1)

Flibanserin — frequently asked questions

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