darolutamide · Bayer Healthcare · NDA 212099

Nubeqa

Earliest generic entry, as listed

17 Jun 2042

Blocked by patent: US 12329742.

Listed patents · 10 unexpired

17 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 12329742	drug product · sets the listed date	17 Jun 2042	listed 2 Jul 2025
US 12611397	drug product	2 Jul 2040	listed 15 May 2026
US 11168058	drug substance, drug product	27 Feb 2038	listed 27 Jan 2022
US 10010530	drug substance	28 Jan 2036	listed 27 Aug 2019
US 10383853	drug substance	28 Jan 2036	listed 27 Aug 2019
US 10835515	drug product, use U-2605, U-4208, U-4209, U-4210	28 Jan 2036	4 listing rows
US 10835515 listing row	drug product, use U-2605	28 Jan 2036	listed 11 Dec 2020
US 10835515 listing row	drug product, use U-4208	28 Jan 2036	listed 11 Dec 2020
US 10835515 listing row	drug product, use U-4209	28 Jan 2036	listed 11 Dec 2020
US 10835515 listing row	drug product, use U-4210	28 Jan 2036	listed 11 Dec 2020
US 8975254	drug substance, drug product, use U-4208, U-4209, U-4210	25 Mar 2033	3 listing rows
US 8975254 listing row	drug substance, drug product, use U-4208	25 Mar 2033	listed 27 Aug 2019
US 8975254 listing row	drug substance, drug product, use U-4209	25 Mar 2033	listed 27 Aug 2019
US 8975254 listing row	drug substance, drug product, use U-4210	25 Mar 2033	listed 27 Aug 2019
US 10711013	drug substance, drug product	27 Oct 2030	listed 11 Aug 2020
US 11046713	drug substance	27 Oct 2030	listed 28 Jul 2021
US 9657003	drug substance, drug product, use U-4208, U-4209, U-4210	27 Oct 2030	3 listing rows
US 9657003 listing row	drug substance, drug product, use U-4208	27 Oct 2030	listed 27 Aug 2019
US 9657003 listing row	drug substance, drug product, use U-4209	27 Oct 2030	listed 27 Aug 2019
US 9657003 listing row	drug substance, drug product, use U-4210	27 Oct 2030	listed 27 Aug 2019

Exclusivities · 1 unexpired

I-971

new indication (3 years)

3 Jun 2028

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · product	Form	Strength	Approved	Listed expiry
212099 · 001 · RLD	tablet, oral	300MG	30 Jul 2019	17 Jun 2042