➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Merck
Baxter
Medtronic
Moodys

Last Updated: August 4, 2020

DrugPatentWatch Database Preview

RISPERIDONE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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, Apotex Inc, Celltrion, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, 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.

Drug Prices for RISPERIDONE

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

SponsorPhase
Alen GrešEarly Phase 1
Shanghai Jiao Tong University School of MedicinePhase 4
University of RochesterPhase 2

See all RISPERIDONE clinical trials

Generic filers with tentative approvals for RISPERIDONE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1MG/MLSOLUTION; 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
Medical Subject Heading (MeSH) Categories for RISPERIDONE
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc RISPERIDONE risperidone TABLET;ORAL 077953-002 Sep 15, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 076996-004 Apr 19, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc RISPERIDONE risperidone SOLUTION;ORAL 202386-001 Jan 12, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Jubilant Cadista RISPERIDONE risperidone TABLET;ORAL 078828-002 Mar 23, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Synthon Pharms RISPERIDONE risperidone TABLET;ORAL 078187-006 Oct 22, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharma RISPERIDONE risperidone TABLET;ORAL 077769-004 Oct 16, 2008 DISCN 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007   Start Trial   Start Trial
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-003 Apr 2, 2003   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007   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 021346-004 Apr 12, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for RISPERIDONE

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Baxter
Moodys
Dow
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.