cliffwatch

aripiprazole lauroxil · Alkermes Inc · NDA 207533

Aristada

Earliest generic entry, as listed · earliest of 4 marketed strengths
6 Apr 2039

Blocked by patent: US 11273158, US 12251381. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 19 unexpired

PatentClaimsExpires
US 11273158use U-5436 Apr 2039
US 12251381use U-5436 Apr 2039
US 10238651use U-240219 Mar 2035
US 10813928use U-240219 Mar 2035
US 10813928use U-298319 Mar 2035
US 11406632use U-240219 Mar 2035
US 12653822use U-240219 Mar 2035
US 9452131use U-240219 Mar 2035
US 9526726product19 Mar 2035
US 11969469product6 Apr 2034
US 9193685product, use U-54324 Oct 2033
US 11097006product, use U-76419 Sep 2033
US 12311027product, use U-54319 Sep 2033
US 12629366product, use U-7646 Dec 2032
US 9034867product, use U-5437 Nov 2032
US 10226458use U-54319 Mar 2032
US 8431576substance26 Oct 2030
US 10112903substance, use U-54324 Jun 2030
US 8796276use U-54324 Jun 2030

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

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 · 4

NDA · productFormStrengthListed expiry
207533 · 001 · RLDsuspension, extended release, intramuscular441MG/1.6ML (275.63MG/ML)6 Apr 2039
207533 · 002 · RLDsuspension, extended release, intramuscular662MG/2.4ML (275.83MG/ML)6 Apr 2039
207533 · 003 · RLDsuspension, extended release, intramuscular882MG/3.2ML (275.63MG/ML)6 Apr 2039
207533 · 004 · RLDsuspension, extended release, intramuscular1064MG/3.9ML (272.82MG/ML)6 Apr 2039