aripiprazole · Otsuka · NDA 021436, 021713, 021729, 021866

Abilify

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

2 Mar 2027

Blocked by patent: US 8759350. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 1 unexpired

Patent	Claims	Expires	Notes
US 8759350	use U-1529	2 Mar 2027	9 strengths · listed 22 Jul 2014

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

25 Oct 2026Generic approved · 021713-00122 Oct 2025
25 Oct 2026Generic approved · 021729-00218 Feb 2026
24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021436-0042 Mar 2027
24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021436-0032 Mar 2027
24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021436-0022 Mar 2027
24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021436-0012 Mar 2027
24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021436-0052 Mar 2027
24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021436-0062 Mar 2027
24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021729-0032 Mar 2027
24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021729-0022 Mar 2027
24 Oct 2026Enters 12-month window basis: patent, carve-out possible · 021713-0012 Mar 2027

Products covered · 12

NDA · product	Form	Strength	Approved	Listed expiry
021436 · 001 · RLD	tablet, oral	10MG	15 Nov 2002	2 Mar 2027
021436 · 002 · RLD	tablet, oral	15MG	15 Nov 2002	2 Mar 2027
021436 · 003 · RLD	tablet, oral	20MG	15 Nov 2002	2 Mar 2027
021436 · 004 · RLD	tablet, oral	30MG	15 Nov 2002	2 Mar 2027
021436 · 005 · RLD	tablet, oral	5MG	15 Nov 2002	2 Mar 2027
021436 · 006 · RLD	tablet, oral	2MG	15 Nov 2002	2 Mar 2027
021713 · 001 · RLD · discontinued	solution, oral	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	10 Dec 2004	2 Mar 2027
021729 · 002 · RLD · discontinued	tablet, orally disintegrating, oral	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	7 Jun 2006	2 Mar 2027
021729 · 003 · RLD · discontinued	tablet, orally disintegrating, oral	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	7 Jun 2006	2 Mar 2027
021729 · 004 · RLD · discontinued	tablet, orally disintegrating, oral	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	7 Jun 2006	open
021729 · 005 · RLD · discontinued	tablet, orally disintegrating, oral	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	7 Jun 2006	open
021866 · 001 · discontinued	injectable, intramuscular	9.75MG/1.3ML (7.5MG/ML)	20 Sep 2006	open

Expired or delisted (1)

US 9125939 · use U-1749 · 28 Jul 2026