cliffwatch

cariprazine hydrochloride · Abbvie · NDA 204370

Vraylar

Earliest generic entry, as listed · earliest of 6 marketed strengths
17 Mar 2030

Blocked by patent: US 7737142.

Listed patents · 26 unexpired

PatentClaimsExpires
US 7737142—17 Mar 2030
US RE47350—16 Jan 2030
US RE49110—16 Jan 2030
US RE49302—16 Jan 2030
US 7737142substance, product, use U-350317 Sep 2029
US 7737142substance, product, use U-254517 Sep 2029
US 7737142substance, product, use U-254417 Sep 2029
US 7737142substance, product, use U-175017 Sep 2029
US 7737142substance, product, use U-254317 Sep 2029
US RE47350use U-254316 Jul 2029
US RE47350use U-175016 Jul 2029
US RE47350use U-254516 Jul 2029
US RE47350use U-254416 Jul 2029
US RE47350use U-350316 Jul 2029
US RE49110use U-254416 Jul 2029
US RE49110use U-350316 Jul 2029
US RE49110use U-254516 Jul 2029
US RE49110use U-254316 Jul 2029
US RE49302use U-350316 Jul 2029
US RE49302use U-254316 Jul 2029
US RE49302use U-254416 Jul 2029
US RE49302use U-254516 Jul 2029
US 7943621—20 Jun 2029
US 7943621—16 Jun 2029
US 7943621substance, product20 Dec 2028
US 7943621substance, product16 Dec 2028

Exclusivities · 3 unexpired

PEDpediatric (6 months added)18 Jun 2029
M-14miscellaneous (3 years)18 Dec 2028
NPPnew patient population18 Dec 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

  • 25 Oct 2026Generic approved · 204370-001

Products covered · 6

NDA · productFormStrengthListed expiry
204370 · 001 · RLDcapsule, oralEQ 1.5MG BASE17 Mar 2030
204370 · 002 · RLDcapsule, oralEQ 3MG BASE17 Mar 2030
204370 · 003 · RLDcapsule, oralEQ 4.5MG BASE17 Mar 2030
204370 · 004 · RLDcapsule, oralEQ 6MG BASE17 Mar 2030
204370 · 005 · RLDcapsule, oralEQ 0.5MG BASE17 Mar 2030
204370 · 006 · RLDcapsule, oralEQ 0.75MG BASE17 Mar 2030