Question 1

Is there a generic for Daprodustat?

Accepted Answer

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

Question 2

What is the reference-listed drug for Daprodustat?

Accepted Answer

JESDUVROQ (NDA 216951, GLAXOSMITHKLINE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Daprodustat?

Accepted Answer

The Orange Book lists 6 patents against Daprodustat products, with the earliest listed expiry in 2027. 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 Daprodustat have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 5 marketing-exclusivity periods for Daprodustat. 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 Daprodustat are approved?

Accepted Answer

Daprodustat is approved in the following dosage form: tablet.

Patent	Expires	In	Type
8815884	Jun 22, 2027	in 1 yr	ProductU-1238
8557834	Jun 22, 2027	in 1 yr	U-1238
11643397	Jun 22, 2027	in 1 yr	SubstanceU-3535
8324208	Dec 11, 2028	in 2 yr 6 mo	SubstanceProduct
11117871	Mar 13, 2038	in 11 yr 11 mo	SubstanceProductU-3535
11649217	Mar 13, 2038	in 11 yr 11 mo	ProductU-3535

Daprodustat

Brand (NDA) products · tablet

Marketing exclusivity (5)

Listed patents (6)

Daprodustat — frequently asked questions

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