Vyxeos is a drug owned by Celator Pharmaceuticals Inc. It is protected by 9 US drug patents filed from 2017 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 15, 2032. Details of Vyxeos's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10166184 | Method of lyophilizing liposomes |
Oct, 2032
(7 years from now) | Active |
| US10835492 | Method of lyophilizing liposomes |
Oct, 2032
(7 years from now) | Active |
| US10028912 | Method of lyophilizing liposomes |
Oct, 2032
(7 years from now) | Active |
| US8092828 | Fixed drug ratios for treatment of hematopoietic cancers and proliferative disorders |
Apr, 2029
(4 years from now) | Active |
| US8022279 | Liposomal formulations of anthracycline agents and cytidine analogs |
Sep, 2027
(2 years from now) | Active |
| US7850990 | Compositions for delivery of drug combinations |
Jan, 2027
(2 years from now) | Active |
| US9271931 | Compositions for delivery of drug combinations |
Jan, 2027
(2 years from now) | Active |
| US8518437 | Lipid carrier compositions with enhanced blood stability |
Jun, 2026
(1 year, 5 months from now) | Active |
| US8431806 | Liposomal formulations of anthracycline agents and cytidine analogs |
Apr, 2025
(4 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 Vyxeos's patents.
Latest Legal Activities on Vyxeos's Patents
Given below is the list of recent legal activities going on the following patents of Vyxeos.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 May, 2024 | US10835492 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Jun, 2023 | US8092828 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Mar, 2023 | US8022279 |
| Correspondence Address Change Critical | 07 Mar, 2023 | US8518437 |
| Correspondence Address Change Critical | 27 Feb, 2023 | US8431806 |
| Correspondence Address Change Critical | 27 Feb, 2023 | US8092828 |
| Email Notification Critical | 03 Jan, 2023 | US10835492 |
| Change in Power of Attorney (May Include Associate POA) Critical | 03 Jan, 2023 | US10028912 |
| Change in Power of Attorney (May Include Associate POA) Critical | 03 Jan, 2023 | US8092828 |
| Email Notification Critical | 03 Jan, 2023 | US10166184 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Vyxeos and ongoing litigations to help you estimate the early arrival of Vyxeos generic.
Vyxeos's Litigations
Vyxeos been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 06, 2010, against patent number US8518437. The petitioner , challenged the validity of this patent, with Paul Tardi et al as the respondent. Click below to track the latest information on how companies are challenging Vyxeos's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9271931 | October, 2012 |
Decision
(31 Aug, 2015) | Paul Tardi et al | |
| US8518437 | December, 2010 |
Decision
(05 Mar, 2013) | Paul Tardi et al | |
FDA has granted some exclusivities to Vyxeos. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vyxeos, 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 Vyxeos.
Exclusivity Information
Vyxeos holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Vyxeos's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Aug 03, 2020 |
| New Patient Population(NPP) | Mar 30, 2024 |
| Orphan Drug Exclusivity(ODE-287) | Aug 03, 2024 |
| Orphan Drug Exclusivity(ODE-350) | Mar 30, 2028 |
Several oppositions have been filed on Vyxeos'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 Vyxeos's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vyxeos patents.
Vyxeos's Oppositions Filed in EPO
Vyxeos has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 15, 2018, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP08730048A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP17200498A | Oct, 2022 | Generics [UK] Limited | Granted and Under Opposition |
| EP17200498A | Oct, 2022 | SANDOZ AG | Granted and Under Opposition |
| EP17200498A | Oct, 2022 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP12841616A | Apr, 2020 | D Young & Co LLP | Granted and Under Opposition |
| EP12841616A | Apr, 2020 | SANDOZ AG | Granted and Under Opposition |
| EP08730048A | Aug, 2018 | Generics (U.K.) Limited | Revoked |
| EP08730048A | Aug, 2018 | Teva Pharmaceutical Industries Ltd | Revoked |
US patents provide insights into the exclusivity only within the United States, but Vyxeos 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 Vyxeos's family patents as well as insights into ongoing legal events on those patents.
Vyxeos's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vyxeos's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 15, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vyxeos Generics:
There are no approved generic versions for Vyxeos as of now.
About Vyxeos
Vyxeos is a drug owned by Celator Pharmaceuticals Inc. It is used for treating newly-diagnosed therapy-related acute myeloid leukemia (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in children and adults. Vyxeos uses Cytarabine; Daunorubicin as an active ingredient. Vyxeos was launched by Celator Pharms in 2017.
Approval Date:
Vyxeos was approved by FDA for market use on 03 August, 2017.
Active Ingredient:
Vyxeos uses Cytarabine; Daunorubicin as the active ingredient. Check out other Drugs and Companies using Cytarabine; Daunorubicin ingredient
Treatment:
Vyxeos is used for treating newly-diagnosed therapy-related acute myeloid leukemia (T-AML) or AML with myelodysplasia-related changes (AML-MRC) in children and adults.
Dosage:
Vyxeos is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG;44MG | POWDER | Prescription | INTRAVENOUS |