Details for New Drug Application (NDA): 207793
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NDA 207793 describes ONIVYDE, which is a drug marketed by Ipsen and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the ONIVYDE profile page.
The generic ingredient in ONIVYDE is irinotecan hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
The generic ingredient in ONIVYDE is irinotecan hydrochloride. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
Summary for 207793
| Tradename: | ONIVYDE |
| Applicant: | Ipsen |
| Ingredient: | irinotecan hydrochloride |
| Patents: | 14 |
Pharmacology for NDA: 207793
| Mechanism of Action | Topoisomerase Inhibitors |
Suppliers and Packaging for NDA: 207793
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793 | NDA | Ipsen Biopharmaceuticals, Inc. | 15054-0043 | 15054-0043-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE, LIPOSOMAL;INTRAVENOUS | Strength | EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | ||||
| Approval Date: | Oct 22, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 13, 2031 | ||||||||
| Regulatory Exclusivity Use: | FOR FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA | ||||||||
| Regulatory Exclusivity Expiration: | Feb 13, 2027 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL AND LEUCOVORIN, FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA | ||||||||
| Patent: | 10,456,360 | Patent Expiration: | Oct 15, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 207793
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | 10,722,508 | ⤷ Start Trial |
| Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | 9,724,303 | ⤷ Start Trial |
| Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | 8,992,970 | ⤷ Start Trial |
| Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | 9,730,891 | ⤷ Start Trial |
| Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | 8,703,181 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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