RISPERDAL CONSTA Drug Patent Profile
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When do Risperdal Consta patents expire, and when can generic versions of Risperdal Consta launch?
Risperdal Consta is a drug marketed by Janssen Pharms and is included in one NDA.
The generic ingredient in RISPERDAL CONSTA is risperidone. There are thirty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the risperidone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Risperdal Consta
A generic version of RISPERDAL CONSTA was approved as risperidone by APOTEX INC on September 15th, 2008.
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Questions you can ask:
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Summary for RISPERDAL CONSTA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 143 |
| Clinical Trials: | 45 |
| Patent Applications: | 4,067 |
| Drug Prices: | Drug price information for RISPERDAL CONSTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RISPERDAL CONSTA |
| What excipients (inactive ingredients) are in RISPERDAL CONSTA? | RISPERDAL CONSTA excipients list |
| DailyMed Link: | RISPERDAL CONSTA at DailyMed |
Recent Clinical Trials for RISPERDAL CONSTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gazda, Thomas D., M.D., PC | Phase 4 |
| Otsuka America Pharmaceutical | Phase 4 |
| Zogenix, Inc. | Phase 1 |
US Patents and Regulatory Information for RISPERDAL CONSTA
| 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 CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-004 | Apr 12, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-003 | Oct 29, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-001 | Oct 29, 2003 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-002 | Oct 29, 2003 | AB | RX | Yes | 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 RISPERDAL CONSTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-004 | Apr 12, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-003 | 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 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 | 021346-001 | Oct 29, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-002 | Oct 29, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for RISPERDAL CONSTA
| 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 CONSTA
See the table below for patents covering RISPERDAL CONSTA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 046034 | UN MATERIAL PARTICULADO, MICROPARTICULAS DE UNA MATRIZ BIODEGRADABLE Y BIOCOMPATIBLE, UNA COMPOSICION FARMACEUTICA Y EL USO DE PARTICULAS PARA LA FABRICACION DE UN MEDICAMENTO | ⤷ Sign Up |
| Slovenia | 1210942 | ⤷ Sign Up | |
| Spain | 2251850 | ⤷ Sign Up | |
| Poland | 329720 | ⤷ Sign Up | |
| Brazil | PI0111060 | composição adequada para injeção através de uma agulha em um hospedeiro e métodos para sua preparação | ⤷ Sign Up |
| Cyprus | 1801 | 1,2-Benzisoxazol-3-yl and 1,2-benzisothiazol-3-yl derivatives | ⤷ Sign Up |
| Norway | 861230 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RISPERDAL CONSTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0196132 | SPC/GB93/036 | United Kingdom | ⤷ Sign Up | SPC/GB93/036:, EXPIRES: 20071207 |
| 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 |
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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