Viewing data from:

UZEDY

NDA

RISPERIDONE | N213586 | TEVA NEUROSCIENCE INC

7 strengths6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Nov. 12, 2027

Nov. 12, 2027

Apr. 5, 2033

Sep. 11, 2040

Mar. 17, 2042

Sep. 11, 2040

Apr. 28, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Uzedy (2023)

Total Spending

$9.8M

Total Claims

3,121

Beneficiaries

1,164

Avg Cost/Unit

$9214.19

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain18 active DMFs14 inactive

17 active API suppliers hold Drug Master Files for this ingredient.

JANSSEN PHARMACEUTICA NVRISPERIDONE (R064766) DRUG SUBSTANCE

DMF 114381995

TAPI NL BVRISPERIDONE USP

DMF 156042001

INKE SARISPERIDONE

DMF 156822001

DR REDDYS LABORATORIES LTDRISPERIDONE FORM-1 USP

DMF 169022003

CIPLA LTDRISPERIDONE USP

DMF 169632003

MATRIX PHARMACORP PRIVATE LTDRISPERIDONE USP

DMF 175202004

ZYDUS LIFESCIENCES LTDRISPERIDONE USP

DMF 180682005

APITORIA PHARMA PRIVATE LTDRISPERIDONE USP

DMF 181202005

INTERQUIM SARISPERIDONE

DMF 182572005

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDRISPERIDONE USP

DMF 205182007

SUN PHARMACEUTICAL INDUSTRIES LTDRISPERIDONE USP

DMF 214462008

TORRENT PHARMACEUTICALS LTDRISPERIDONE

DMF 216302008

IPCA LABORATORIES LTDRISPERIDONE USP

DMF 229112009

WUXI JIDA PHARMACEUTICAL CO LTDRISPERIDONE

DMF 256052011

TAPI NL BVRISPERIDONE STERILE

DMF 354342021

CHIERON ACTIVE INGREDIENTS PRIVATE LTDRISPERIDONE

DMF 356462021

ICROM SRLRISPERIDONE

DMF 359742021

STHREE CHEMICALS PRIVATE LTDRISPERIDONE USP

DMF 415792025

DR REDDYS LABORATORIES LTDInactiveRISPERIDONE EP

DMF 160232002

MEDICHEM SAInactiveRISPERIDONE

DMF 165162003

CATALENT PHARMA SOLUTIONS LLCInactiveRISPERIDONE 0.5 MG AND 1.0 MG ORALLY DISINTEGRATING TABLETS

DMF 169782003

CATALENT PHARMA SOLUTIONS LLCInactiveRISPERIDONE 2.0 MG ORALLY DISINTEGRATING TABLETS

DMF 172602004

GEDEON RICHTER LTDInactiveRISPERIDONE

DMF 184462005

LUPIN LTDInactiveRISPERIDONE USP

DMF 192672006

ERREGIERRE SPAInactiveRISPERIDONE PH. EUR.

DMF 193702006

WANBURY LTDInactiveRISPERIDONE

DMF 204092007

JIANGSU JIWA RINTECH PHARMACEUTICAL CO LTDInactiveRISPERIDONE EP, NON-STERILE DRUG SUBSTANCE

DMF 206562007

RPG LIFE SCIENCES LTDInactiveRISPERIDONE USP

DMF 224322009

APOTEX PHARMACHEM INDIA PVT LTDInactiveRISPERIDONE USP

DMF 228532009

QILU PHARMACEUTICAL CO LTDInactiveRISPERIDONE (NON STERILE, API)

DMF 242902010

QILU PHARMACEUTICAL CO LTDInactiveRISPERIDONE PROCESS II (NON STERILE, API)

DMF 252022011

ICROM SPAInactiveRISPERIDONE

DMF 256832011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Oct 15, 2025	SUPPL -8	View Letter (PDF)
Oct 15, 2025	SUPPL -9	View Letter (PDF)
Feb 7, 2025	SUPPL -7	View Letter (PDF)
Nov 2, 2023	SUPPL -1	View Letter (PDF)
May 1, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — 50MG/0.14ML (50MG/0.14ML)

RLD

6 patents1 exclusivity▴

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: Apr 28, 2023

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8221778	Nov 12, 2027	—	—	Yes		—
8741327	Nov 12, 2027	—	—	Yes		—
9023897	Apr 5, 2033	—	—	Yes	—	—
12128132	Sep 11, 2040	—	—	Yes		—
12329851	Mar 17, 2042	—	—	—		—
12383493	Sep 11, 2040	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
NP	Apr 28, 2026	Expired

#002 — 75MG/0.21ML (75MG/0.21ML)

RLD

6 patents1 exclusivity▾

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: Apr 28, 2023

#003 — 100MG/0.28ML (100MG/0.28ML)

RLD

6 patents1 exclusivity▾

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: Apr 28, 2023

#004 — 125MG/0.35ML (125MG/0.35ML)

RLD

6 patents1 exclusivity▾

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: Apr 28, 2023

#005 — 150MG/0.42ML (150MG/0.42ML)

RLD

6 patents1 exclusivity▾

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: Apr 28, 2023

#006 — 200MG/0.56ML (200MG/0.56ML)

RLD

6 patents1 exclusivity▾

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: Apr 28, 2023

#007 — 250MG/0.7ML (250MG/0.7ML)

RLD

6 patents1 exclusivity▾

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | Approved: Apr 28, 2023