RISPERIDONE Drug Patent Profile
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When do Risperidone patents expire, and what generic alternatives are available?
Risperidone is a drug marketed by 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, 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, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Novitium Pharma, 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-six NDAs.
The generic ingredient in RISPERIDONE 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 Risperidone
A generic version of RISPERIDONE was approved as risperidone by APOTEX INC on September 15th, 2008.
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Questions you can ask:
- What is the 5 year forecast for RISPERIDONE?
- What are the global sales for RISPERIDONE?
- What is Average Wholesale Price for RISPERIDONE?
Summary for RISPERIDONE
| US Patents: | 0 |
| Applicants: | 39 |
| NDAs: | 46 |
| Finished Product Suppliers / Packagers: | 33 |
| Raw Ingredient (Bulk) Api Vendors: | 143 |
| Clinical Trials: | 557 |
| Patent Applications: | 977 |
| Drug Prices: | Drug price information 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
Recent Clinical Trials for RISPERIDONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Consorcio Centro de Investigación Biomédica en Red (CIBER) | Phase 4 |
| Instituto de Salud Carlos III | Phase 4 |
| Assiut University | Phase 4 |
Pharmacology for RISPERIDONE
| Drug Class | Atypical Antipsychotic |
Medical Subject Heading (MeSH) Categories for RISPERIDONE
Anatomical Therapeutic Chemical (ATC) Classes for RISPERIDONE
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | RISPERIDONE | risperidone | TABLET;ORAL | 078071-003 | Jun 17, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Heritage Pharma Avet | RISPERIDONE | risperidone | TABLET;ORAL | 077769-001 | Oct 16, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 077494-006 | Apr 30, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Ltd | RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 077328-002 | Oct 5, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Synthon Pharms | RISPERIDONE | risperidone | TABLET;ORAL | 078187-003 | Oct 22, 2009 | DISCN | 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 |
EU/EMA Drug Approvals for RISPERIDONE
| 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 |
