Jevtana Kit is a drug owned by Sanofi Aventis Us Inc. It is protected by 13 US drug patents filed from 2013 to 2020. Out of these, 6 drug patents are active and 7 have expired. Jevtana Kit's patents have been open to challenges since 18 November, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 27, 2031. Details of Jevtana Kit'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. | |||
| US7241907 | Acetone solvate of dimethoxy docetaxel and its process of preparation |
Dec, 2025
(11 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). | |||
|
US8927592 (Pediatric) | Antitumoral use of cabazitaxel |
Apr, 2031
(6 years from now) | Active |
| US10716777 | Antitumoral use of cabazitaxel |
Oct, 2030
(5 years from now) | Active |
| US8927592 | Antitumoral use of cabazitaxel |
Oct, 2030
(5 years from now) | Active |
| US10583110 | Antitumoral use of cabazitaxel |
Oct, 2030
(5 years from now) | Active |
|
US7241907 (Pediatric) | Acetone solvate of dimethoxy docetaxel and its process of preparation |
Jun, 2026
(1 year, 5 months from now) | Active |
|
US5847170 (Pediatric) | Taxoids, their preparation and pharmaceutical compositions containing them |
Sep, 2021
(3 years ago) |
Expired
|
| US5847170 | Taxoids, their preparation and pharmaceutical compositions containing them |
Mar, 2016
(8 years ago) |
Expired
|
| US6331635 | Taxoids, their preparation and pharmaceutical compositions containing them |
Mar, 2016
(8 years ago) |
Expired
|
| US6387946 | Methods for treating pathological conditions of abnormal cell proliferation |
Mar, 2016
(8 years ago) |
Expired
|
| US6372780 | Methods of treating cell lines expressing multidrug resistance P-glycoprotein |
Mar, 2016
(8 years ago) |
Expired
|
| US5438072 | Taxoid-based compositions |
Nov, 2013
(11 years ago) |
Expired
|
| US5698582 | Compositions containing taxane derivatives |
Jul, 2012
(12 years ago) |
Expired
|
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 Jevtana Kit's patents.
Latest Legal Activities on Jevtana Kit's Patents
Given below is the list of recent legal activities going on the following patents of Jevtana Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jan, 2024 | US10716777 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Aug, 2023 | US10583110 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Jun, 2022 | US8927592 (Litigated) |
| Review Certificate Mailed | 23 Aug, 2021 | US8927592 (Litigated) |
| Review Certificate | 23 Jul, 2021 | US8927592 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 21 Jul, 2020 | US10716777 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Jul, 2020 | US10716777 |
| Email Notification Critical | 01 Jul, 2020 | US10716777 |
| Issue Notification Mailed Critical | 30 Jun, 2020 | US10716777 |
| Application Is Considered Ready for Issue Critical | 15 Jun, 2020 | US10716777 |
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 Jevtana Kit and ongoing litigations to help you estimate the early arrival of Jevtana Kit generic.
Jevtana Kit's Litigations
Jevtana Kit been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 17, 2016, against patent number US5847170. The petitioner Mylan Laboratories Limited, challenged the validity of this patent, with Aventis Pharma S.A. as the respondent. Click below to track the latest information on how companies are challenging Jevtana Kit's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US5847170 | October, 2018 |
Terminated-Denied
(06 May, 2019) | Aventis Pharma S.A. | Neptune Generics, LLC |
| US8927592 | March, 2016 |
Final Written Decision
(21 Sep, 2017) | AVENTIS PHARMA S.A. et al. | Mylan Laboratories Limited et al. |
| US5847170 | February, 2016 |
Terminated-Denied
(23 Aug, 2016) | Aventis Pharma S.A. | Mylan Laboratories Limited |
FDA has granted some exclusivities to Jevtana Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jevtana Kit, 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 Jevtana Kit.
Exclusivity Information
Jevtana Kit holds 5 exclusivities. All of its exclusivities have expired in 2023. Details of Jevtana Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 17, 2015 |
| M(M-201) | May 17, 2020 |
| M(M-209) | Sep 14, 2020 |
| Pediatric Exclusivity(PED) | Nov 17, 2020 |
| M(M-128) | Dec 18, 2023 |
Several oppositions have been filed on Jevtana Kit'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 Jevtana Kit's generic, the next section provides detailed information on ongoing and past EP oppositions related to Jevtana Kit patents.
Jevtana Kit's Oppositions Filed in EPO
Jevtana Kit has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 14, 2013, by Stada Arzneimittel Ag. This opposition was filed on patent number EP04787385A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP10782039A | Dec, 2021 | Maiwald Patent- und Rechtsanwaltsgesellschaft mbH | Granted and Under Opposition |
| EP10782039A | Dec, 2021 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP10782039A | Dec, 2021 | Vossius & Partner Patentanwälte Rechtsanwälte mbB | Granted and Under Opposition |
| EP10782039A | Jun, 2021 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP10782039A | Mar, 2021 | Dr. Reddy's Laboratories Ltd./ Betapharm Arzneimittel GmbH | Granted and Under Opposition |
| EP10782039A | Mar, 2021 | Fresenius Kabi Deutschland GmbH | Granted and Under Opposition |
| EP10782039A | Mar, 2021 | medac Gesellschaft für klinische Spezialpräparate mbH | Granted and Under Opposition |
| EP10782039A | Mar, 2021 | Zentiva k.s. | Granted and Under Opposition |
| EP10782039A | Mar, 2021 | EVER Valinject GmbH | Granted and Under Opposition |
| EP10782039A | Mar, 2021 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP10782039A | Mar, 2021 | Accord Healthcare Ltd | Granted and Under Opposition |
| EP10782039A | Mar, 2021 | Glenmark Pharmaceuticals Europe Ltd | Granted and Under Opposition |
| EP04787385A | Oct, 2013 | STADA Arzneimittel AG | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Jevtana Kit 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 Jevtana Kit's family patents as well as insights into ongoing legal events on those patents.
Jevtana Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Jevtana Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 27, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jevtana Kit Generic API suppliers:
Cabazitaxel is the generic name for the brand Jevtana Kit. 5 different companies have already filed for the generic of Jevtana Kit, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Jevtana Kit's generic
How can I launch a generic of Jevtana Kit before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Jevtana Kit's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Jevtana Kit'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 Jevtana Kit -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 60 mg/1.5 mL | 17 Jun, 2014 | 8 | 23 Jun, 2022 | 10 Dec, 2025 | Eligible Deferred |
Alternative Brands for Jevtana Kit
Jevtana Kit which is used for treating metastatic castration-resistant prostate cancer after prior treatment with docetaxel by administering cabazitaxel in combination with prednisone or prednisolone., has several other brand drugs in the same treatment category . 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 | ||
|---|---|---|---|---|
| Boehringer Ingelheim |
| |||
About Jevtana Kit
Jevtana Kit is a drug owned by Sanofi Aventis Us Inc. It is used for treating metastatic castration-resistant prostate cancer after prior treatment with docetaxel by administering cabazitaxel in combination with prednisone or prednisolone. Jevtana Kit uses Cabazitaxel as an active ingredient. Jevtana Kit was launched by Sanofi Aventis Us in 2010.
Approval Date:
Jevtana Kit was approved by FDA for market use on 17 June, 2010.
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 Jevtana Kit is 17 June, 2010, its NCE-1 date is estimated to be 18 November, 2019.
Active Ingredient:
Jevtana Kit uses Cabazitaxel as the active ingredient. Check out other Drugs and Companies using Cabazitaxel ingredient
Treatment:
Jevtana Kit is used for treating metastatic castration-resistant prostate cancer after prior treatment with docetaxel by administering cabazitaxel in combination with prednisone or prednisolone.
Dosage:
Jevtana Kit is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG/1.5ML (40MG/ML) | SOLUTION | Prescription | INTRAVENOUS |