cliffwatch

darolutamide · Bayer Healthcare · NDA 212099

Nubeqa

Earliest generic entry, as listed
17 Jun 2042

Blocked by patent: US 12329742.

Listed patents · 17 unexpired

PatentClaimsExpires
US 12329742product17 Jun 2042
US 12611397product2 Jul 2040
US 11168058substance, product27 Feb 2038
US 10010530substance28 Jan 2036
US 10383853substance28 Jan 2036
US 10835515product, use U-421028 Jan 2036
US 10835515product, use U-420828 Jan 2036
US 10835515product, use U-420928 Jan 2036
US 10835515product, use U-260528 Jan 2036
US 8975254substance, product, use U-420825 Mar 2033
US 8975254substance, product, use U-420925 Mar 2033
US 8975254substance, product, use U-421025 Mar 2033
US 10711013substance, product27 Oct 2030
US 11046713substance27 Oct 2030
US 9657003substance, product, use U-421027 Oct 2030
US 9657003substance, product, use U-420827 Oct 2030
US 9657003substance, product, use U-420927 Oct 2030

Exclusivities · 1 unexpired

I-971new 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 · productFormStrengthListed expiry
212099 · 001 · RLDtablet, oral300MG17 Jun 2042