ONIVYDE Drug Patent Profile
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When do Onivyde patents expire, and when can generic versions of Onivyde launch?
Onivyde is a drug marketed by Ipsen and is included in one NDA. There are eighteen patents protecting this drug.
This drug has one hundred and forty-seven patent family members in twenty-eight countries.
The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
DrugPatentWatch® 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: | 147 |
US Patents: | 18 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 94 |
Clinical Trials: | 35 |
Patent Applications: | 37 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ONIVYDE |
What excipients (inactive ingredients) are in ONIVYDE? | ONIVYDE excipients list |
DailyMed Link: | ONIVYDE at DailyMed |
Recent Clinical Trials for ONIVYDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Kaohsiung Medical University Chung-Ho Memorial Hospital | Phase 1/Phase 2 |
Taipei Veterans General Hospital, Taiwan | Phase 1/Phase 2 |
China Medical University Hospital | Phase 1/Phase 2 |
Pharmacology for ONIVYDE
Drug Class | Topoisomerase Inhibitor |
Mechanism of Action | Topoisomerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ONIVYDE
US Patents and Regulatory Information for ONIVYDE
ONIVYDE is protected by twenty-one US patents and two FDA Regulatory Exclusivities.
Patents protecting ONIVYDE
Stabilizing camptothecin pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liposomes useful for drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
Stabilizing camptothecin pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF METASTATIC PANCREATIC ADENOCARCINOMA IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL, AND LEUCOVORIN
Methods for treating pancreatic cancer using combination therapies
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
Liposomes useful for drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liposomes useful for drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liposomes useful for drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PANCREATIC CANCER
Liposomes useful for drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, IN A PATIENT HOMOZYGOUS FOR THE UGT1A1*28 ALLELE
Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF EXOCRINE PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PANCREATIC CANCER THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
Methods for treating pancreatic cancer using combination therapies
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, IN A PATIENT NOT HOMOZYGOUS FOR THE UGT1A1*28 ALLELE
Methods for treating pancreatic cancer using combination therapies
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
Liposomes useful for drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liposomes useful for drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
Liposomes useful for drug delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting ONIVYDE
FOR FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
Exclusivity Expiration: ⤷ Try a Trial
IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL AND LEUCOVORIN, FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a 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
See the table below for patents covering ONIVYDE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3266456 | COMBINAISONS CONTENANT DE L'IRINOTÉCAN LIPOSOMAL, DU 5-FU ET DU LEUCOVORIN DESTINÉES AU TRAITEMENT DU CANCER PANCRÉATIQUE (COMBINATIONS OF LIPOSOMAL IRINOTECAN, 5-FU AND LEUCOVORIN FOR THE TREATMENT OF PANCREATIC CANCER) | ⤷ Try a Trial |
Taiwan | 202143966 | Stabilizing camptothecin pharmaceutical compositions | ⤷ Try a Trial |
Spain | 2880089 | ⤷ Try a Trial | |
Taiwan | 201412345 | Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan | ⤷ Try a Trial |
China | 103948545 | Liposomes useful for drug delivery | ⤷ Try a Trial |
Mexico | 2018001802 | METODOS PARA EL TRATAMIENTO DEL CANCER DE PANCREAS METASTASICO CON EL USO DE TERAPIAS DE COMBINACION QUE COMPRENDEN IRINOTECAN LIPOSOMAL Y OXALIPLATINO. (METHODS FOR TREATING METASTATIC PANCREATIC CANCER USING COMBINATION THERAPIES COMPRISING LIPOSOMAL IRINOTECAN AND OXALIPLATIN.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ONIVYDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1746976 | 122017000042 | Germany | ⤷ Try a 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 | 1790033-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008 |
1746976 | 300885 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018 |
1746976 | 132017000076571 | Italy | ⤷ Try a 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 | SPC/GB17/043 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018 |
1746976 | 2017/029 | Ireland | ⤷ Try a Trial | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |