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ONIVYDE Drug Profile
» See Plans and Pricing
When do Onivyde patents expire, and when can generic versions of Onivyde launch?
Onivyde is a drug marketed by Ipsen Inc and is included in one NDA. There are thirteen patents protecting this drug.
This drug has ninety-one patent family members in twenty-five countries.
The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Onivyde
A generic version of ONIVYDE was approved as irinotecan hydrochloride by ACTAVIS TOTOWA on February 27th, 2008.
Summary for ONIVYDE
| International Patents: | 91 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 91 |
| Clinical Trials: | 23 |
| Patent Applications: | 4,974 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ONIVYDE |
| DailyMed Link: | ONIVYDE at DailyMed |
Recent Clinical Trials for ONIVYDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 3 |
| ECOG-ACRIN Cancer Research Group | Phase 3 |
| Samsung Medical Center | Phase 1 |
Pharmacology for ONIVYDE
| Drug Class | Topoisomerase Inhibitor |
| Mechanism of Action | Topoisomerase Inhibitors |
US Patents and Regulatory Information for ONIVYDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ipsen Inc | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Ipsen Inc | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Ipsen Inc | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ipsen Inc | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ONIVYDE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101462819 | Start Trial |
| Mexico | 2018004328 | Start Trial |
| Australia | 2005240131 | Start Trial |
| Taiwan | I359029 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ONIVYDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1746976 | 300885 | Netherlands | Start Trial | PRODUCT NAME: ONIVYDE - IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018 |
| 1746976 | 132017000076571 | Italy | Start Trial | PRODUCT NAME: SALE SUCROSOFATO DI IRINOTECAN, COME IL SALE SUCROSOFATO DI IRINOTECAN IN UN LIPOSOMA PEGILATO(ONIVYDE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1130, 20161018 |
| 1746976 | 122017000042 | Germany | Start Trial | PRODUCT NAME: LRINOTECAN SUCROSOFAT-SALZ, WIE Z.B. LRINOTECAN SUCROSOFAT-SALZ IN EINEM PEGYLIERTEN LIPOSOM WIE BEISPIELWEISE EINEM LIPOSOM, DAS 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLIN, CHOLESTERIN UND N-(OMEGA-METHOXYPOLY(ETHYLENGLYKOL) (MOLEKULARGEWICHT 2000)OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYLETHANOLAMIN Z.B. IM MOLVERHAELTNIS 3:2:0,015 UMFASST.; REGISTRATION NO/DATE: EU/1/16/1130 20161014 |
| 1746976 | 2017C/027 | Belgium | Start Trial | PRODUCT NAME: LE SEL DE SUCROSOFATE D'IRINOTECAN, PAR EXEMPLE LE SEL DE SUCROSOFATE D'IRINOTECAN INCORPORE DANS UN LIPOSOME MODIFIE PAR PEGYLATION, TEL QU'UN LIPOSOME COMPRENANT DE LA 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLINE, DU CHOLESTEROL ET DU N- (OMEGA-METHOXY POLY (ETHYLENE GLYCOL) (POIDS MOLECULAIRE 2000) -OXYCARBONYL)-1,2-DISEEAROYLPHOSPHATIDYLETHANOLAMINE, PAR EXEMPLE DANS DES RAPPORTS MOLAIRES 3: 2: 0,015; OU COMME DEMANDE AUXILIAIRE, IRINOTECAN; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
