Risperidone - Generic Drug Details

What are the generic drug sources for risperidone and what is the scope of freedom to operate?

Risperidone is the generic ingredient in four branded drugs marketed by Indivior Inc, Janssen Pharms, Amneal Pharms, Ani Pharms, Atlantide, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Torrent, Tris Pharma Inc, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Heritage Pharma Avet, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Celltrion, Jubilant Cadista, Mylan, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-nine NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has thirty-eight patent family members in seventeen countries.

There are thirty drug master file entries for risperidone. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for risperidone

International Patents:	38
US Patents:	9
Tradenames:	4
Applicants:	39
NDAs:	49
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	548
Patent Applications:	7,082
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for risperidone
Drug Sales Revenues:	Drug sales revenues for risperidone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for risperidone
What excipients (inactive ingredients) are in risperidone?	risperidone excipients list
DailyMed Link:	risperidone at DailyMed

See drug prices for risperidone

See drug sales revenues for risperidone

Recent Clinical Trials for risperidone

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

Sponsor	Phase
University of Minho	Phase 2
Clinical Academic Center (2CA-Braga)	Phase 2
University of Georgia	Phase 4

See all risperidone clinical trials

Generic filers with tentative approvals for RISPERIDONE

Applicant	Application No.	Strength	Dosage Form
		1MG/ML	SOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for risperidone

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for risperidone

Antipsychotic Agents

Dopamine Antagonists

Serotonin Antagonists

Paragraph IV (Patent) Challenges for RISPERIDONE

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 risperidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	RISPERIDONE	risperidone	TABLET;ORAL	077860-004	Dec 5, 2008		DISCN	No	No
Mylan	RISPERIDONE	risperidone	TABLET;ORAL	076288-003	Sep 15, 2008		DISCN	No	No
Zydus Pharms Usa Inc	RISPERIDONE	risperidone	TABLET;ORAL	078040-003	Oct 16, 2008	AB	RX	No	No
Mylan Pharms Inc	RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	091537-006	Feb 12, 2013		DISCN	No	No
Synthon Pharms	RISPERIDONE	risperidone	TABLET;ORAL	078187-002	Oct 22, 2009		DISCN	No	No

Expired US Patents for risperidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-008	May 10, 1999
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-002	Apr 2, 2003
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003

EU/EMA Drug Approvals for risperidone

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 risperidone

Country	Patent Number	Title	Estimated Expiration
Canada	2624088	FORMULATION DE MEDICAMENTS A PETITES MOLECULES A LIBERATION PROLONGEE (SUSTAINED RELEASE SMALL MOLECULE DRUG FORMULATION)
Mexico	2009012781	FORMULACIONES DE TRANSFERENCIA SOSTENIDA DE COMPUESTOS DE RISPERIDONA. (SUSTAINED DELIVERY FORMULATIONS OF RISPERIDONE COMPOUNDS.)
Japan	2014240436	リスペリドン化合物の徐放送達製剤 (SUSTAINED RELEASE DELIVERY FORMULATION OF RISPERIDONE COMPOUND)
Japan	2010531807
Mexico	354603	FORMULACIONES DE TRANSFERENCIA SOSTENIDA DE COMPUESTOS DE RISPERIDONA. (SUSTAINED DELIVERY FORMULATIONS OF RISPERIDONE COMPOUNDS.)

Supplementary Protection Certificates for risperidone

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