PERSERIS KIT Drug Patent Profile

Which patents cover Perseris Kit, and what generic alternatives are available?

Perseris Kit is a drug marketed by Indivior and is included in one NDA. There are ten patents protecting this drug.

This drug has thirty-eight patent family members in seventeen countries.

The generic ingredient in PERSERIS KIT is risperidone. There are thirty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the risperidone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Perseris Kit

A generic version of PERSERIS KIT was approved as risperidone by APOTEX INC on September 15^th, 2008.

Summary for PERSERIS KIT

International Patents:	38
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	1
Patent Applications:	3,982
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PERSERIS KIT
DailyMed Link:	PERSERIS KIT at DailyMed

Recent Clinical Trials for PERSERIS KIT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Indivior Inc.	Phase 4

See all PERSERIS KIT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for PERSERIS KIT

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for PERSERIS KIT

PERSERIS KIT is protected by ten US patents.

Patents protecting PERSERIS KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-002	Jul 27, 2018		RX	Yes	Yes			Y
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No			Y
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-002	Jul 27, 2018		RX	Yes	Yes			Y
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-002	Jul 27, 2018		RX	Yes	Yes			Y
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No			Y

EU/EMA Drug Approvals for PERSERIS KIT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Laboratorios Farmacéuticos Rovi, S.A.	Okedi	risperidone	EMEA/H/C/005406 Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.	Authorised	no	no	no	2022-02-14

International Patents for PERSERIS KIT

See the table below for patents covering PERSERIS KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1143731	利培酮類化合物的緩釋製劑 (SUSTAINED DELIVERY FORMULATIONS OF RISPERIDONE COMPOUNDS)
Denmark	2361609
Japan	2014012712	SUSTAINED RELEASE SMALL MOLECULE DRUG FORMULATION
World Intellectual Property Organization (WIPO)	2008153611
Mexico	354603	FORMULACIONES DE TRANSFERENCIA SOSTENIDA DE COMPUESTOS DE RISPERIDONA. (SUSTAINED DELIVERY FORMULATIONS OF RISPERIDONE COMPOUNDS.)
Argentina	056554	FORMULACION DE FARMACO DE MOLECULA PEQUENA DE LIBERACION SOSTENIDA
Japan	2016128411	小分子薬の持続放出製剤 (SUSTAINED RELEASE PREPARATION OF SMALL MOLECULE DRUG)

Supplementary Protection Certificates for PERSERIS KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208