Onivyde is a drug owned by Ipsen Biopharmaceuticals Inc. It is protected by 19 US drug patents filed from 2015 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 15, 2036. Details of Onivyde's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8147867 | Liposomes useful for drug delivery |
Aug, 2028
(3 years from now) | Active |
| US8329213 | Liposomes useful for drug delivery |
Jan, 2027
(2 years from now) | Active |
| US10722508 | Liposomes useful for drug delivery |
May, 2025
(5 months from now) | Active |
| US8992970 | Liposomes useful for drug delivery |
May, 2025
(5 months from now) | Active |
| US9724303 | Liposomes useful for drug delivery |
May, 2025
(5 months from now) | Active |
| US9782349 | Liposomes useful for drug delivery |
May, 2025
(5 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10456360 | Stabilizing camptothecin pharmaceutical compositions |
Oct, 2036
(11 years from now) | Active |
| US10993914 | Stabilizing camptothecin pharmaceutical compositions |
Oct, 2036
(11 years from now) | Active |
| US12059497 | Stabilizing camptothecin pharmaceutical compositions |
Oct, 2036
(11 years from now) | Active |
| US11344552 | Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal irinotecan and oxaliplatin |
Aug, 2036
(11 years from now) | Active |
| US9717724 | Methods for treating pancreatic cancer using combination therapies |
Jun, 2033
(8 years from now) | Active |
| US9492442 | Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan |
Jun, 2033
(8 years from now) | Active |
| US10980795 | Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan |
Jun, 2033
(8 years from now) | Active |
| US9364473 | Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan |
Jun, 2033
(8 years from now) | Active |
| US11369597 | Methods for treating pancreatic cancer using combination therapies |
Jun, 2033
(8 years from now) | Active |
| US9339497 | Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan |
Jun, 2033
(8 years from now) | Active |
| US9452162 | Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan |
Jun, 2033
(8 years from now) | Active |
| US9730891 | Liposomes useful for drug delivery |
May, 2025
(5 months from now) | Active |
| US8703181 | Liposomes useful for drug delivery |
May, 2025
(5 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Onivyde's patents.
Latest Legal Activities on Onivyde's Patents
Given below is the list of recent legal activities going on the following patents of Onivyde.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 May, 2024 | US8329213 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 May, 2024 | US9492442 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Mar, 2024 | US9452162 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Jan, 2024 | US10722508 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Nov, 2023 | US9364473 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Nov, 2023 | US9339497 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2023 | US8147867 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Apr, 2023 | US10456360 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Sep, 2022 | US8992970 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Jun, 2022 | US11369597 |
FDA has granted several exclusivities to Onivyde. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Onivyde, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Onivyde.
Exclusivity Information
Onivyde holds 5 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Onivyde's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 22, 2018 |
| Orphan Drug Exclusivity(ODE) | Oct 22, 2022 |
| Orphan Drug Exclusivity(ODE-99) | Oct 22, 2022 |
| New Indication(I-932) | Feb 13, 2027 |
| Orphan Drug Exclusivity(ODE-463) | Feb 13, 2031 |
Several oppositions have been filed on Onivyde's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Onivyde's generic, the next section provides detailed information on ongoing and past EP oppositions related to Onivyde patents.
Onivyde's Oppositions Filed in EPO
Onivyde has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 11, 2017, by Teva Pharmaceuticals Inc.. This opposition was filed on patent number EP05745505A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17169098A | Feb, 2022 | Generics [UK] Limited | Granted and Under Opposition |
| EP17169098A | Feb, 2022 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP17169098A | Feb, 2022 | Sandoz AG | Granted and Under Opposition |
| EP13731230A | Feb, 2018 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP05745505A | Oct, 2017 | Teva Pharmaceuticals Inc. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Onivyde is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Onivyde's family patents as well as insights into ongoing legal events on those patents.
Onivyde's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Onivyde's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 15, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Onivyde Generic API suppliers:
Irinotecan Hydrochloride is the generic name for the brand Onivyde. 23 different companies have already filed for the generic of Onivyde, with Sandoz having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Onivyde's generic
Alternative Brands for Onivyde
Onivyde which is used for treating metastatic pancreatic adenocarcinoma that has progressed on gemcitabine-based therapy., has several other brand drugs in the same treatment category and using the same active ingredient (Irinotecan Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Bristol-myers |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Irinotecan Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Pfizer Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Irinotecan Hydrochloride, Onivyde's active ingredient. Check the complete list of approved generic manufacturers for Onivyde
About Onivyde
Onivyde is a drug owned by Ipsen Biopharmaceuticals Inc. It is used for treating metastatic pancreatic adenocarcinoma that has progressed on gemcitabine-based therapy. Onivyde uses Irinotecan Hydrochloride as an active ingredient. Onivyde was launched by Ipsen in 2015.
Approval Date:
Onivyde was approved by FDA for market use on 22 October, 2015.
Active Ingredient:
Onivyde uses Irinotecan Hydrochloride as the active ingredient. Check out other Drugs and Companies using Irinotecan Hydrochloride ingredient
Treatment:
Onivyde is used for treating metastatic pancreatic adenocarcinoma that has progressed on gemcitabine-based therapy.
Dosage:
Onivyde is available in injectable, liposomal form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | INJECTABLE, LIPOSOMAL | Prescription | INTRAVENOUS |