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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 |
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 |
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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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
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
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
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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