Yondelis is a drug owned by Janssen Products Lp. It is protected by 2 US drug patents filed from 2015 to 2018 out of which none have expired yet. Yondelis's patents have been open to challenges since 23 April, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 07, 2028. Details of Yondelis'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). | |||
|
US8895557 (Pediatric) | Pharmaceutical formulations of ecteinascidin compounds |
Jul, 2028
(3 years from now) | Active |
| US8895557 | Pharmaceutical formulations of ecteinascidin compounds |
Jan, 2028
(3 years 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 Yondelis's patents.
Latest Legal Activities on Yondelis's Patents
Given below is the list of recent legal activities going on the following patents of Yondelis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 May, 2022 | US8895557 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Jul, 2020 | US8895557 |
| Email Notification Critical | 01 Jul, 2020 | US8895557 |
| Correspondence Address Change Critical | 29 Jun, 2020 | US8895557 |
| Email Notification Critical | 18 Jun, 2020 | US8895557 |
| Change in Power of Attorney (May Include Associate POA) Critical | 18 Jun, 2020 | US8895557 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 May, 2018 | US8895557 |
| Patent Issue Date Used in PTA Calculation Critical | 25 Nov, 2014 | US8895557 |
| Recordation of Patent Grant Mailed Critical | 25 Nov, 2014 | US8895557 |
| Email Notification Critical | 06 Nov, 2014 | US8895557 |
FDA has granted several exclusivities to Yondelis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Yondelis, 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 Yondelis.
Exclusivity Information
Yondelis holds 5 exclusivities. All of its exclusivities have expired in 2023. Details of Yondelis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 23, 2020 |
| M(M-232) | Jun 29, 2021 |
| Orphan Drug Exclusivity(ODE) | Oct 23, 2022 |
| Orphan Drug Exclusivity(ODE-100) | Oct 23, 2022 |
| Pediatric Exclusivity(PED) | Apr 23, 2023 |
US patents provide insights into the exclusivity only within the United States, but Yondelis 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 Yondelis's family patents as well as insights into ongoing legal events on those patents.
Yondelis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Yondelis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 07, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Yondelis Generics:
There are no approved generic versions for Yondelis as of now.
How can I launch a generic of Yondelis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Yondelis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Yondelis's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Yondelis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/vial | 23 Apr, 2020 | 2 | 07 Jan, 2028 |
About Yondelis
Yondelis is a drug owned by Janssen Products Lp. Yondelis uses Trabectedin as an active ingredient. Yondelis was launched by Janssen Prods in 2015.
Approval Date:
Yondelis was approved by FDA for market use on 23 October, 2015.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Yondelis is 23 October, 2015, its NCE-1 date is estimated to be 23 April, 2022.
Active Ingredient:
Yondelis uses Trabectedin as the active ingredient. Check out other Drugs and Companies using Trabectedin ingredient
Dosage:
Yondelis is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/VIAL | POWDER | Prescription | INTRAVENOUS |