Risperidone - Generic Drug Details

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

Risperidone is the generic ingredient in seven branded drugs marketed by Labs Farms Rovi Sa, Shandong Luye, Indivior, Janssen Pharms, Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sciegen Pharms Inc, Taro, Tris Pharma Inc, Wockhardt, Teva, Actavis Labs Fl Inc, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Endo Operations, Jubilant Generics, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Esjay Pharma, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, 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 fifty-four NDAs. There are thirty-eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has three hundred and thirty-two patent family members in forty-three 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:	332
US Patents:	38
Tradenames:	7
Applicants:	44
NDAs:	54
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	557
Patent Applications:	7,021
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

Drug Sales Revenue Trends for risperidone

See drug sales revenues for risperidone

Recent Clinical Trials for risperidone

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

Sponsor	Phase
Assiut University	Phase 4
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 4
Instituto de Salud Carlos III	Phase 4

See all risperidone clinical trials

Generic filers with tentative approvals for RISPERIDONE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for risperidone

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

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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
West Ward Pharms	RISPERIDONE	risperidone	TABLET;ORAL	078740-001	May 29, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Synthon Pharms	RISPERIDONE	risperidone	TABLET;ORAL	078187-004	Oct 22, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-005	Apr 28, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Indivior	PERSERIS KIT	risperidone	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	210655-001	Jul 27, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
West Ward Pharms	RISPERIDONE	risperidone	TABLET;ORAL	078740-004	May 29, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-001	Apr 28, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ipca Labs Ltd	RISPERIDONE	risperidone	TABLET;ORAL	205104-006	Jun 26, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 risperidone

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-003	Oct 29, 2003	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-004	Apr 12, 2007	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-008	May 10, 1999	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for risperidone

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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 risperidone

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Country	Patent Number	Title	Estimated Expiration
Japan	5882993		⤷ Sign Up
Chile	2012003350	Composicion farmaceutica inyectable de liberacion controlada que comprende risperidona, un copolimero de acido lactico y glicolico, un disolvente miscible en agua, una viscosidad y una relacion de masas de disolvente/farmaco y de farmaco/polimero especificas; kit farmaceutico; y uso para tratar esquizofrenia o trastornos bipolares.	⤷ Sign Up
European Patent Office	2575890	COMPOSITION RETARD INJECTABLE ANTIPSYCHOTIQUE (ANTIPSYCHOTIC INJECTABLE DEPOT COMPOSITION)	⤷ Sign Up
Eurasian Patent Organization	201390783	БИОРАЗЛАГАЕМЫЕ КОМПОЗИЦИИ ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ	⤷ Sign Up
South Africa	201501426	INJECTABLE COMPOSITIONS COMPRISING LETROZOLE OR ANASTROZOLE	⤷ Sign Up
South Korea	101539313		⤷ Sign Up
Slovenia	2879661		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for risperidone

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

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