Viewing data from:

RISPERDAL CONSTA

NDA

RISPERIDONE | N021346 | JANSSEN PHARMACEUTICALS INC

4 strengths0 unique patents0 unique exclusivities

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Alkermes Pharma Ireland Limited et al v. Luye Pharma Group LTD. et al 3:2019cv02227 1 patentrisperidone	CASD	2019-11-22	Terminated 2019-11-25	—
Alkermes Pharma Ireland Limited et al v. Luye Pharma Group Ltd. et al 1:2019cv01340 1 patentrisperidone	D. Del.	2019-07-17	Terminated 2019-12-03	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Risperdal Consta (2023)

Total Spending

$181.8M

Total Claims

132,766

Beneficiaries

11,151

Avg Cost/Unit

$968.00

Spending Trend

$229.6M(2019)→$212.8M(2020)→$201.6M(2021)→$191.2M(2022)→$181.8M(2023)

YoY Change:+5.5%

5yr CAGR:+5.3%

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

Medicare Part B Spending

CMS physician-administered drug spending for Risperdal Consta (2023)

Total Spending

$2.6M

Total Claims

3,316

Beneficiaries

335

ASP Price

—

HCPCS: J2794 — Injection, risperidone (risperdal consta), 0.5 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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

36 letters from Drugs@FDA

Date	Submission	Document
Feb 7, 2025	SUPPL -65	View Letter (PDF)
Feb 17, 2021	SUPPL -61	View Letter (PDF)
Jan 8, 2021	SUPPL -64	View Letter (PDF)
Feb 6, 2020	SUPPL -63	View Letter (PDF)
Feb 13, 2019	SUPPL -60	View Letter (PDF)
Jul 30, 2018	SUPPL -58	View Letter (PDF)
Mar 2, 2017	SUPPL -56	View Letter (PDF)
Mar 3, 2016	SUPPL -55	View Letter (PDF)
May 9, 2014	SUPPL -51	View Letter (PDF)
Mar 13, 2012	SUPPL -44	View Letter (PDF)
Dec 13, 2011	SUPPL -41	View Letter (PDF)
Dec 13, 2011	SUPPL -32	View Letter (PDF)
Sep 28, 2011	SUPPL -43	View Letter (PDF)
Sep 28, 2011	SUPPL -37	View Letter (PDF)
Aug 26, 2011	SUPPL -36	View Letter (PDF)
Jun 17, 2011	SUPPL -42	View Letter (PDF)
Dec 6, 2010	SUPPL -40	View Letter (PDF)
Sep 1, 2010	SUPPL -38	View Letter (PDF)
Sep 1, 2010	SUPPL -35	View Letter (PDF)
Sep 1, 2010	SUPPL -31	View Letter (PDF)
Sep 1, 2010	SUPPL -39	View Letter (PDF)
Aug 6, 2009	SUPPL -33	View Letter (PDF)
May 20, 2009	SUPPL -28	View Letter (PDF)
May 20, 2009	SUPPL -25	View Letter (PDF)
Oct 14, 2008	SUPPL -22	View Letter (PDF)
Oct 14, 2008	SUPPL -21	View Letter (PDF)
Oct 14, 2008	SUPPL -23	View Letter (PDF)
Oct 14, 2008	SUPPL -26	View Letter (PDF)
Aug 19, 2008	SUPPL -27	View Letter (PDF)
Apr 20, 2007	SUPPL -15	View Letter (PDF)
Mar 15, 2007	SUPPL -20	View Letter (PDF)
Oct 23, 2006	SUPPL -9	View Letter (PDF)
Sep 25, 2006	SUPPL -13	View Letter (PDF)
Aug 4, 2006	SUPPL -11	View Letter (PDF)
Aug 19, 2005	SUPPL -10	View Letter (PDF)
Nov 28, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 25MG/VIAL

RLDAB

0 patents0 exclusivities▴

POWDER;INTRAMUSCULAR | Approved: Oct 29, 2003

No patent or exclusivity listings for this strength.

#002 — 37.5MG/VIAL

RLDAB

0 patents0 exclusivities▾

POWDER;INTRAMUSCULAR | Approved: Oct 29, 2003

#003 — 50MG/VIAL

RLDAB

0 patents0 exclusivities▾

POWDER;INTRAMUSCULAR | Approved: Oct 29, 2003

#004 — 12.5MG/VIAL

RLDAB

0 patents0 exclusivities▾

POWDER;INTRAMUSCULAR | Approved: Apr 12, 2007