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 four branded drugs marketed by Indivior Inc, Janssen Pharms, Amneal Pharms, Ani Pharms Inc, Aurobindo Pharma Ltd, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Torrent, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Heritage Pharma, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Celltrion, Chartwell Molecular, 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 eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has ninety patent family members in twenty-eight countries.

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

Summary for risperidone

International Patents:	90
US Patents:	8
Tradenames:	4
Applicants:	39
NDAs:	49
Drug Master File Entries:	30
Suppliers / Packagers:	37
Bulk Api Vendors:	125
Clinical Trials:	507
Patent Applications:	6,958
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

Drug Sales Revenue Trends for risperidone

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Recent Clinical Trials for risperidone

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

Sponsor	Phase
Beth Israel Deaconess Medical Center	Phase 4
University of Georgia	Phase 4
Hartford Hospital	Phase 4

See all risperidone clinical trials

Generic filers with tentative approvals for RISPERIDONE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	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	NDA	Submissiondate
RISPERDAL	TABLET, ORALLY DISINTEGRATING;ORAL	risperidone	021444	2005-04-11
RISPERDAL	TABLET, ORALLY DISINTEGRATING;ORAL	risperidone	021444	2005-03-23
RISPERDAL	TABLET;ORAL	risperidone	020272
RISPERDAL	SOLUTION;ORAL	risperidone	020588

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
Ajanta Pharma Ltd	RISPERIDONE	risperidone	TABLET;ORAL	201003-005	Aug 24, 2011	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Heritage Pharma	RISPERIDONE	risperidone	TABLET;ORAL	076228-003	Jun 30, 2008		DISCN	No	No	Start Trial	Start Trial				Start Trial
Zydus Pharms Usa Inc	RISPERIDONE	risperidone	TABLET;ORAL	078040-002	Oct 16, 2008	AB	RX	No	No	Start Trial	Start Trial				Start 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 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	Start Trial	Start Trial
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003	Start Trial	Start Trial
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003	Start Trial	Start Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-007	Jan 27, 1999	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for risperidone

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Country	Patent Number	Estimated Expiration
Mexico	337286	Start Trial
Hong Kong	1054319	Start Trial
Canada	2624088	Start Trial
Denmark	1940351	Start Trial
>Country	>Patent Number	>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	Start Trial	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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