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 nineteen patents protecting this drug.
This drug has one hundred and fifty-one 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.
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Summary for onivyde
International Patents: | 151 |
US Patents: | 19 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 94 |
Clinical Trials: | 35 |
Patent Applications: | 36 |
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 |
---|---|
Taipei Veterans General Hospital, Taiwan | Phase 1/Phase 2 |
China Medical University Hospital | Phase 1/Phase 2 |
National Cheng-Kung University Hospital | Phase 1/Phase 2 |
Pharmacology for onivyde
Drug Class | Topoisomerase Inhibitor |
Mechanism of Action | Topoisomerase Inhibitors |
US Patents and Regulatory Information for onivyde
onivyde is protected by twenty-two US patents and two FDA Regulatory Exclusivities.
Patents protecting onivyde
Stabilizing camptothecin pharmaceutical compositions
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Liposomes useful for drug delivery
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Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
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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
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Patented Use: TREATMENT OF METASTATIC PANCREATIC ADENOCARCINOMA IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL, AND LEUCOVORIN
Methods for treating pancreatic cancer using combination therapies
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Patented Use: TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
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Liposomes useful for drug delivery
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Liposomes useful for drug delivery
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Liposomes useful for drug delivery
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Patented Use: TREATMENT OF PANCREATIC CANCER
Liposomes useful for drug delivery
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Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
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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
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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
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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
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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
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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
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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
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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
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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
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Liposomes useful for drug delivery
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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
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FDA Regulatory Exclusivity protecting onivyde
FOR FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
Exclusivity Expiration: ⤷ Sign Up
IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL AND LEUCOVORIN, FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH METASTATIC PANCREATIC ADENOCARCINOMA
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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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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 |
---|---|---|---|
Poland | 1746976 | ⤷ Sign Up | |
Russian Federation | 2015155368 | ЛИПОСОМНЫЕ КОМПОЗИЦИИ, ИСПОЛЬЗУЕМЫЕ ДЛЯ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ | ⤷ Sign Up |
Luxembourg | C00026 | ⤷ Sign Up | |
Canada | 2875824 | METHODES DE TRAITEMENT DU CANCER DU PANCREAS A L'AIDE DE POLYTHERAPIES COMPORTANT L'IRINOTECAN EN LIPOSOME (METHODS FOR TREATING PANCREATIC CANCER USING COMBINATION THERAPIES COMPRISING LIPOSOMAL IRINOTECAN) | ⤷ Sign Up |
Japan | 2024128046 | 安定化カンプトテシン医薬組成物 | ⤷ Sign Up |
Israel | 257149 | שיטות לטיפול בגרורות סרטן הלבלב באמצעות טיפולים משולבים הכוללים אירינוטקאן ליפוזומלי ואוקסאליפלאטין (Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal irinotecan and oxaliplatin) | ⤷ Sign Up |
China | 114073678 | 稳定喜树碱药物组合物 (Stable camptothecin pharmaceutical composition) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for onivyde
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1746976 | C01746976/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017 |
1746976 | CA 2017 00030 | Denmark | ⤷ Sign Up | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018 |
1746976 | 2017/029 | Ireland | ⤷ Sign Up | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014 |
1746976 | 17C1027 | France | ⤷ Sign Up | PRODUCT NAME: SEL DE SUCROSOFATE D'IRINOTECAN; REGISTRATION NO/DATE: EU/1/16/1130 20161018 |
1746976 | 2017C/027 | Belgium | ⤷ Sign Up | 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 |
1746976 | 300885 | Netherlands | ⤷ Sign Up | PRODUCT NAME: IRINOTECANSUCROSOFAATZOUT; REGISTRATION NO/DATE: EU/1/16/1130 20161018 |
1746976 | CR 2017 00030 | Denmark | ⤷ Sign Up | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REG. NO/DATE: EU/1/16/1130 20161018 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |