RISPERDAL Drug Patent Profile

When do Risperdal patents expire, and what generic alternatives are available?

Risperdal is a drug marketed by Janssen Pharms and is included in four NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Risperdal

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

Summary for RISPERDAL

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	157
Patent Applications:	1,008
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RISPERDAL
Drug Sales Revenues:	Drug sales revenues for RISPERDAL
What excipients (inactive ingredients) are in RISPERDAL?	RISPERDAL excipients list
DailyMed Link:	RISPERDAL at DailyMed

See drug prices for RISPERDAL

See drug sales revenues for RISPERDAL

Recent Clinical Trials for RISPERDAL

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

Sponsor	Phase
Lyndra Inc.	Phase 3
Beth Israel Deaconess Medical Center	Phase 4
University of Chicago	Phase 4

See all RISPERDAL clinical trials

Pharmacology for RISPERDAL

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for RISPERDAL

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for RISPERDAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RISPERDAL	Orally Disintegrating Tablets	risperidone	0.25 mg	021444	1	2005-04-11
RISPERDAL	Orally Disintegrating Tablets	risperidone	3 mg and 4 mg	021444	1	2005-03-23

US Patents and Regulatory Information for RISPERDAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996	AA	RX	Yes	Yes
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-008	May 10, 1999	AB	RX	Yes	No
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-003	Apr 2, 2003		DISCN	Yes	No
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-004	Dec 29, 1993	AB	RX	Yes	No
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-007	Jan 27, 1999	AB	RX	Yes	No
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003	AB	RX	Yes	No
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-004	Apr 12, 2007	AB	RX	Yes	No

Expired US Patents for RISPERDAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-004	Dec 29, 1993
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-008	May 10, 1999
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-001	Dec 29, 1993
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-005	Dec 23, 2004
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-002	Apr 2, 2003
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996

EU/EMA Drug Approvals for RISPERDAL

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 RISPERDAL

See the table below for patents covering RISPERDAL around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	893564
Ireland	860801
South Korea	910000165
Spain	2075036
Japan	3107566
Denmark	0910345
Canada	2257303	FORMES POSOLOGIQUES BICONVEXES A DESINTEGRATION RAPIDE (BICONVEX RAPIDLY DISINTEGRATING DOSAGE FORMS)

Supplementary Protection Certificates for RISPERDAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0368388	07C0044	France		PRODUCT NAME: PALIPERIDONE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/395/01 DU 20070626; REGISTRATION NO/DATE AT EEC: EU/1/07/395/01 DU 20070625
0368388	78/2007	Austria		PRODUCT NAME: PALIPERIDON, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625
0196132	SPC/GB93/036	United Kingdom		SPC/GB93/036:, EXPIRES: 20071207
0368388	C300298	Netherlands		PRODUCT NAME: PALIPERIDON, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIE ZOUT; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625
0368388	91362	Luxembourg		91362, EXPIRES: 20141030
0368388	SPC/GB07/065	United Kingdom		PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208