cliffwatch

pirtobrutinib · Loxo Oncol · NDA 216059

Jaypirca

Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Sep 2041

Blocked by patent: US 12109193.

Listed patents · 7 unexpired

11 Orange Book listing rows for 7 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 12109193drug product · sets the listed date14 Sep 2041
US 12268666drug product29 Jul 2039
US 10342780drug substance, drug product16 Dec 2036
US 10464905use U-3518, U-436216 Dec 2036
US 10464905 listing rowuse U-351816 Dec 2036
US 10464905 listing rowuse U-436216 Dec 2036
US 10695323drug substance, drug product, use U-3518, U-436216 Dec 2036
US 10695323 listing rowdrug substance, drug product, use U-351816 Dec 2036
US 10695323 listing rowdrug substance, drug product, use U-436216 Dec 2036
US 10918622use U-3518, U-436216 Dec 2036
US 10918622 listing rowuse U-351816 Dec 2036
US 10918622 listing rowuse U-436216 Dec 2036
US 12220401drug substance, drug product, use U-3518, U-436216 Dec 2036
US 12220401 listing rowdrug substance, drug product, use U-351816 Dec 2036
US 12220401 listing rowdrug substance, drug product, use U-436216 Dec 2036

Exclusivities · 5 unexpired

ODE-518orphan drug (7 years)3 Dec 2032
ODE-451orphan drug (7 years)1 Dec 2030
ODE-424orphan drug (7 years)27 Jan 2030
I-981new indication (3 years)2 Dec 2028
NCEnew chemical entity (5 years)27 Jan 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 · 2

NDA · productFormStrengthListed expiry
216059 · 001 · RLDtablet, oral50MG14 Sep 2041
216059 · 002 · RLDtablet, oral100MG14 Sep 2041