ONIVYDE Drug Patent Profile
✉ Email this page to a colleague
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 |
---|---|
China Medical University Hospital | Phase 1/Phase 2 |
National Cheng-Kung University Hospital | Phase 1/Phase 2 |
Chang Gung Memorial 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Liposomes useful for drug delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF METASTATIC PANCREATIC ADENOCARCINOMA IN COMBINATION WITH OXALIPLATIN, FLUOROURACIL, AND LEUCOVORIN
Methods for treating pancreatic cancer using combination therapies
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Liposomes useful for drug delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Liposomes useful for drug delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PANCREATIC CANCER
Liposomes useful for drug delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Liposomes useful for drug delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Exclusivity Expiration: ⤷ Sign Up
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 | ||||
>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 |
---|---|---|---|
Spain | 2632915 | ⤷ Sign Up | |
Russian Federation | 2018115715 | СТАБИЛИЗИРУЮЩИЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ КАМПТОТЕЦИНА | ⤷ Sign Up |
Hong Kong | 1200694 | 用於藥物輸送的脂質體 (LIPOSOMES USEFUL FOR DRUG DELIVERY) | ⤷ Sign Up |
Australia | 2013202947 | Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan | ⤷ 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 | 1790033-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008 |
1746976 | 122017000042 | Germany | ⤷ Sign Up | 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 |
0137145 | SPC/GB97/010 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: GENERIC NAME: IRINOTECANCHEMICAL NAME: (+)-(4S)-4,11-DIETHYL-4-HYDROXY-9-((4-PIPERIDINOPIPERIDINO)CARBONYLOXY)-1H-PYRANO (3',4':6,7) INDOLIZINO(1,2-B) QUINOLINE-3,14-(4H,12H)-DIONE,OPTIONALLY THE HYDROCHLORIDE SALT THEREOF AND OPTIONALLY THE TRIHYDRATE T; REGISTERED: FR 558822.2 19950505; FR 558823.9 19950505; FR 558824.5 19950505; FR 558825.1 19950505; UK 00012/0302 19961017; UK 00012/0303 19961017 |
1746976 | SPC/GB17/043 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTERED: UK EU/1/16/1130 20161018 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |