cliffwatch

osimertinib mesylate · Astrazeneca · NDA 208065

Tagrisso

Earliest generic entry, as listed · earliest of 2 marketed strengths
26 Nov 2042

Blocked by patent: US 12465608. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 17 unexpired

PatentClaimsExpires
US 12465608use U-382326 Nov 2042
US 10183020product, use U-17772 Jan 2035
US 10183020product, use U-22892 Jan 2035
US 10183020product, use U-38232 Jan 2035
US 10183020product, use U-40102 Jan 2035
US 10183020product, use U-30162 Jan 2035
US 8946235substance, product, use U-38238 Aug 2032
US 8946235substance, product, use U-17778 Aug 2032
US 8946235substance, product, use U-30168 Aug 2032
US 8946235substance, product, use U-40108 Aug 2032
US 8946235substance, product, use U-22898 Aug 2032
US 11524951substance, product25 Jul 2032
US 9732058substance, product, use U-401025 Jul 2032
US 9732058substance, product, use U-301625 Jul 2032
US 9732058substance, product, use U-228925 Jul 2032
US 9732058substance, product, use U-382325 Jul 2032
US 9732058substance, product, use U-177725 Jul 2032

Exclusivities · 3 unexpired

ODE-337orphan drug (7 years)18 Dec 2027
I-952new indication (3 years)25 Sep 2027
I-941new indication (3 years)16 Feb 2027

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
208065 · 001 · RLDtablet, oralEQ 40MG BASE26 Nov 2042
208065 · 002 · RLDtablet, oralEQ 80MG BASE26 Nov 2042