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RYKINDO

NDA

RISPERIDONE | N212849 | SHANDONG LUYE PHARMACEUTICAL CO LTD

4 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

2032

Today

Apr. 10, 2032

Apr. 10, 2032

Apr. 10, 2032

Apr. 10, 2032

Apr. 10, 2032

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
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

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

3 letters from Drugs@FDA

Date	Submission	Document
Jan 22, 2026	SUPPL -3	View Letter (PDF)
Feb 6, 2025	SUPPL -1	View Letter (PDF)
Jan 17, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 12.5MG

RLD

5 patents0 exclusivities▴

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Jan 13, 2023

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9446135	Apr 10, 2032	—	—	Yes		—
9532991	Apr 10, 2032	—	—	Yes		—
10098882	Apr 10, 2032	—	—	Yes		—
10406161	Apr 10, 2032	—	—	Yes		—
11110094	Apr 10, 2032	—	—	Yes	—	—

#002 — 25MG

RLD

5 patents0 exclusivities▾

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Jan 13, 2023

#003 — 37.5MG

RLD

5 patents0 exclusivities▾

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Jan 13, 2023

#004 — 50MG

RLD

5 patents0 exclusivities▾

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Jan 13, 2023