CISAPRIDE MONOHYDRATE - Generic Drug Details
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What are the generic drug sources for cisapride monohydrate and what is the scope of freedom to operate?
Cisapride monohydrate
is the generic ingredient in two branded drugs marketed by Janssen Pharms and Janssen Pharma, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for cisapride monohydrate.
Summary for CISAPRIDE MONOHYDRATE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 3 |
Drug Master File Entries: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 1 |
Patent Applications: | 325 |
Formulation / Manufacturing: | see details |
DailyMed Link: | CISAPRIDE MONOHYDRATE at DailyMed |
Recent Clinical Trials for CISAPRIDE MONOHYDRATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Federal University of São Paulo | Phase 4 |
Medical Subject Heading (MeSH) Categories for CISAPRIDE MONOHYDRATE
Anatomical Therapeutic Chemical (ATC) Classes for CISAPRIDE MONOHYDRATE
US Patents and Regulatory Information for CISAPRIDE MONOHYDRATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Pharma | PROPULSID QUICKSOLV | cisapride monohydrate | TABLET, ORALLY DISINTEGRATING;ORAL | 020767-001 | Nov 7, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Pharms | PROPULSID | cisapride monohydrate | TABLET;ORAL | 020210-001 | Jul 29, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Pharms | PROPULSID | cisapride monohydrate | SUSPENSION;ORAL | 020398-001 | Sep 15, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Pharms | PROPULSID | cisapride monohydrate | TABLET;ORAL | 020210-002 | Dec 23, 1993 | 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 |
Expired US Patents for CISAPRIDE MONOHYDRATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | PROPULSID | cisapride monohydrate | SUSPENSION;ORAL | 020398-001 | Sep 15, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharma | PROPULSID QUICKSOLV | cisapride monohydrate | TABLET, ORALLY DISINTEGRATING;ORAL | 020767-001 | Nov 7, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharma | PROPULSID QUICKSOLV | cisapride monohydrate | TABLET, ORALLY DISINTEGRATING;ORAL | 020767-001 | Nov 7, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | PROPULSID | cisapride monohydrate | TABLET;ORAL | 020210-001 | Jul 29, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | PROPULSID | cisapride monohydrate | TABLET;ORAL | 020210-002 | Dec 23, 1993 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |