Question 1

Is there a generic for Baxdrostat?

Accepted Answer

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

Question 2

What is the reference-listed drug for Baxdrostat?

Accepted Answer

BAXFENDY (NDA 219878, ASTRAZENECA AB) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Baxdrostat?

Accepted Answer

The Orange Book lists 1 patent against Baxdrostat 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 Baxdrostat have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Baxdrostat is approved in the following dosage form: tablet.

Baxdrostat

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (1)

Baxdrostat — frequently asked questions

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