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Risperidone - Generic Drug Details
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This ingredient has one hundred and thirty-one patent family members in thirty-four countries.
There are twenty-nine drug master file entries for risperidone. Sixty-three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for Generic Name: risperidone
| Tradenames: | 3 |
| Patents: | 8 |
| Applicants: | 36 |
| NDAs: | 48 |
| Drug Master File Entries: see list | 29 |
| Suppliers / Packaging: see list | 63 |
| Therapeutic Class: | Antipsychotics Bipolar Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: risperidone
| Drug Class | Atypical Antipsychotic |
Tentative approvals for RISPERIDONE
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | SOLUTION; ORAL | 1MG/ML |
Clinical Trials for: risperidone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Par Pharm | RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 077494-003 | Oct 26, 2009 | RX | No | ||||||||||||||||||||||
Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-002 | Oct 29, 2003 | RX | No | 6,379,703*PED | Jun 30, 2019 | Y | |||||||||||||||||||
Cipla | RISPERIDONE | risperidone | TABLET;ORAL | 077543-006 | May 18, 2011 | RX | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: risperidone
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-003 | Oct 29, 2003 | 4,804,663*PED | <disabled> | ||||||||||||||||||||||
Janssen Pharms | RISPERDAL | risperidone | TABLET;ORAL | 020272-005 | Dec 29, 1993 | 5,158,952*PED | <disabled> | ||||||||||||||||||||||
Janssen Pharms | RISPERDAL CONSTA | risperidone | INJECTABLE;INTRAMUSCULAR | 021346-003 | Oct 29, 2003 | 5,688,801*PED | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: risperidone
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,799,345 | Preparation of injectable suspensions having improved injectability | <disabled in preview> | |||||||||||||||||||||||||||
| 6,290,983 | Preparation of biodegradable, biocompatible microparticles containing a biologically active agent | <disabled in preview> | |||||||||||||||||||||||||||
| 6,495,164 | Preparation of injectable suspensions having improved injectability | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Ingredient: risperidone
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Slovakia | 173798 | <disabled in preview> | |||||||||||||||||||||||||||
| Brazil | 0111060 | <disabled in preview> | |||||||||||||||||||||||||||
| Canada | 2406536 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: RISPERIDONE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0008 | Belgium | <disabled> | PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208 | ||||||||||||||||||||||||||
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How are People Using DrugPatentWatch?
To find generic producers around the world for specific active ingredients.
— Pharmaceutical wholesaler, Estonia
To obtain a list of all currently off-patent approved small molecule therapeutics or those that will come off patent in the next 5 years
— Licensing / business development, Saudi Arabia
For patent related information to plan launch of generics worldwide
— Director, international business, India
To identify Paragraph IV challenge opportunities and for product portfolio development
— Business development, China
For drug patent expirations and intelligence
— Analyst, USA
To get reliable data on drug patent information
— CFO, Pharmaceuticals, Singapore
To know what drugs are coming off patent over the next 5 years
— CRO business development manager, USA
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 verifification 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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