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 (pediatric extension).

FDA has approved 1 generic application (ANDA) for Vraylar, though its earliest generic-entry date is 17 Mar 2030 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 5 unexpired

26 Orange Book listing rows for 5 patents, including 6 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 7737142drug substance, drug product, use U-1750, U-2543, U-2544, U-2545, U-350317 Mar 2030
US 7737142 listing rowdrug substance, drug product, use U-175017 Sep 2029
US 7737142 listing rowdrug substance, drug product, use U-254317 Sep 2029
US 7737142 listing rowdrug substance, drug product, use U-254417 Sep 2029
US 7737142 listing rowdrug substance, drug product, use U-254517 Sep 2029
US 7737142 listing rowdrug substance, drug product, use U-350317 Sep 2029
US 7737142 listing rowpediatric extension · sets the listed date17 Mar 2030
US RE47350use U-1750, U-2543, U-2544, U-2545, U-350316 Jan 2030
US RE47350 listing rowuse U-175016 Jul 2029
US RE47350 listing rowuse U-254316 Jul 2029
US RE47350 listing rowuse U-254416 Jul 2029
US RE47350 listing rowuse U-254516 Jul 2029
US RE47350 listing rowuse U-350316 Jul 2029
US RE47350 listing rowpediatric extension16 Jan 2030
US RE49110use U-2543, U-2544, U-2545, U-350316 Jan 2030
US RE49110 listing rowuse U-254316 Jul 2029
US RE49110 listing rowuse U-254416 Jul 2029
US RE49110 listing rowuse U-254516 Jul 2029
US RE49110 listing rowuse U-350316 Jul 2029
US RE49110 listing rowpediatric extension16 Jan 2030
US RE49302use U-2543, U-2544, U-2545, U-350316 Jan 2030
US RE49302 listing rowuse U-254316 Jul 2029
US RE49302 listing rowuse U-254416 Jul 2029
US RE49302 listing rowuse U-254516 Jul 2029
US RE49302 listing rowuse U-350316 Jul 2029
US RE49302 listing rowpediatric extension16 Jan 2030
US 7943621drug substance, drug product20 Jun 2029
US 7943621 listing rowdrug substance, drug product16 Dec 2028
US 7943621 listing rowdrug substance, drug product20 Dec 2028
US 7943621 listing rowpediatric extension16 Jun 2029
US 7943621 listing rowpediatric extension20 Jun 2029

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

  • Generic approved · ANDA 213982, Aurobindo Pharma Ltd · 204370-001Approved 16 Dec 2025Detected 25 Oct 2026Historical import

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