Risperdal Drug Patent Profile

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Which patents cover Risperdal, and when can generic versions of Risperdal launch?

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-six 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.

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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

Drug patent expirations by year for Risperdal

Recent Clinical Trials for Risperdal

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

Sponsor	Phase
Lyndra Inc.	Phase 3
University of Texas Southwestern Medical Center	Phase 4
Hartford Hospital	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

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Glossary

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

Expired US Patents for Risperdal

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-005	Dec 23, 2004	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-005	Dec 23, 2004	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-002	Apr 2, 2003	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-001	Apr 2, 2003	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-008	May 10, 1999	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-003	Apr 2, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for Risperdal

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for Risperdal

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

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Country	Patent Number	Title	Estimated Expiration
Canada	2046310	PREPARATION D'UN PRODUIT PHARMACEUTIQUE ET AUTRES SYSTEMES MATRICIELS PAR DISSOLUTION EN PHASE SOLIDE (PREPARATION OF PHARMACEUTICAL AND OTHER MATRIX SYSTEMS BY SOLID-STATE DISSOLUTION)	⤷ Try a Trial
Ireland	904520		⤷ Try a Trial
Canada	2257303	FORMES POSOLOGIQUES BICONVEXES A DESINTEGRATION RAPIDE (BICONVEX RAPIDLY DISINTEGRATING DOSAGE FORMS)	⤷ Try a Trial
Singapore	119294		⤷ Try a Trial
Turkey	9500778		⤷ Try a Trial
Hungary	9700082		⤷ Try a Trial
Israel	78250	1,2-BENZISOXAZOL-3-YL AND 1,2-BENZISOTHIAZOL-3-YL DERIVATIVES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for Risperdal

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0368388	78/2007	Austria	⤷ Try a Trial	PRODUCT NAME: PALIPERIDON, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625
0196132	94C0008	Belgium	⤷ Try a Trial	PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
0368388	07C0044	France	⤷ Try a Trial	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
0196132	SPC/GB93/036	United Kingdom	⤷ Try a Trial	SPC/GB93/036:, EXPIRES: 20071207
0368388	SPC/GB07/065	United Kingdom	⤷ Try a Trial	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
0368388	C300298	Netherlands	⤷ Try a Trial	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	⤷ Try a Trial	91362, EXPIRES: 20141030
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Summary for Risperdal

Recent Clinical Trials for Risperdal

Pharmacology for Risperdal

Anatomical Therapeutic Chemical (ATC) Classes for Risperdal

Paragraph IV (Patent) Challenges for RISPERDAL

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