Question 1

Is there a generic for Darolutamide?

Accepted Answer

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

Question 2

What is the reference-listed drug for Darolutamide?

Accepted Answer

NUBEQA (NDA 212099, BAYER HEALTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Darolutamide?

Accepted Answer

The Orange Book lists 10 patents against Darolutamide products, with the earliest listed expiry in 2030. 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 Darolutamide have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Darolutamide is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9657003	Oct 27, 2030	in 4 yr 5 mo	SubstanceProductU-4209
11046713	Oct 27, 2030	in 4 yr 5 mo	Substance
10711013	Oct 27, 2030	in 4 yr 5 mo	SubstanceProduct
8975254	Mar 25, 2033	in 6 yr 10 mo	SubstanceProductU-4208
10835515	Jan 28, 2036	in 9 yr 9 mo	ProductU-4210
10010530	Jan 28, 2036	in 9 yr 9 mo	Substance
10383853	Jan 28, 2036	in 9 yr 9 mo	Substance
11168058	Feb 27, 2038	in 11 yr 10 mo	SubstanceProduct
12611397	Jul 02, 2040	in 14 yr 3 mo	Product
12329742	Jun 17, 2042	in 16 yr 3 mo	Product

Darolutamide

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (10)

Darolutamide — frequently asked questions

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