RISPERDAL Drug Patent Profile
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When do Risperdal patents expire, and what generic alternatives are available?
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 15th, 2008.
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 |
Recent Clinical Trials for RISPERDAL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lyndra Inc. | Phase 3 |
| University of Chicago | Phase 4 |
| University of Texas Southwestern Medical Center | Phase 4 |
Pharmacology for RISPERDAL
| Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for RISPERDAL
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
| 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 | ||||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | RISPERDAL | risperidone | SOLUTION;ORAL | 020588-001 | Jun 10, 1996 | ⤷ 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, ORALLY DISINTEGRATING;ORAL | 021444-004 | Dec 23, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for RISPERDAL
| 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 3686341 | ⤷ Try a Trial | |
| Australia | 2927595 | ⤷ Try a Trial | |
| China | 1191824 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RISPERDAL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0196132 | SPC/GB93/036 | United Kingdom | ⤷ Try a Trial | SPC/GB93/036:, EXPIRES: 20071207 |
| 0368388 | 91362 | Luxembourg | ⤷ Try a Trial | 91362, EXPIRES: 20141030 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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