Ixempra Kit is a drug owned by R-pharm Us Llc. It is protected by 12 US drug patents filed in 2013. Out of these, 1 drug patents are active and 11 have expired. Ixempra Kit's patents have been open to challenges since 18 April, 2014. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 21, 2025. Details of Ixempra 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 focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7312237 (Pediatric) | Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases |
Feb, 2025
(2 months from now) | Active |
| US7312237 | Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases |
Aug, 2024
(3 months ago) |
Expired
|
|
USRE41393 (Pediatric) | Treatment of refractory tumors using epothilone derivatives |
Aug, 2022
(2 years ago) |
Expired
|
|
US6670384 (Pediatric) | Methods of administering epothilone analogs for the treatment of cancer |
Jul, 2022
(2 years ago) |
Expired
|
|
US7022330 (Pediatric) | Parenteral formulation for epothilone analogs |
Jul, 2022
(2 years ago) |
Expired
|
| USRE41393 | Treatment of refractory tumors using epothilone derivatives |
Feb, 2022
(2 years ago) |
Expired
|
| US7022330 | Parenteral formulation for epothilone analogs |
Jan, 2022
(2 years ago) |
Expired
|
| US6670384 | Methods of administering epothilone analogs for the treatment of cancer |
Jan, 2022
(2 years ago) |
Expired
|
|
USRE41911 (Pediatric) | Epothilone derivatives |
Mar, 2021
(3 years ago) |
Expired
|
| USRE41911 | Epothilone derivatives |
Sep, 2020
(4 years ago) |
Expired
|
|
US7125899 (Pediatric) | Epothilone derivatives |
Nov, 2018
(5 years ago) |
Expired
|
| US7125899 | Epothilone derivatives |
May, 2018
(6 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 Ixempra Kit's patents.
Latest Legal Activities on Ixempra Kit's Patents
Given below is the list of recent legal activities going on the following patents of Ixempra Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jun, 2019 | US7312237 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Sep, 2018 | US6670384 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Sep, 2018 | US7125899 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Sep, 2018 | US7022330 |
| Email Notification Critical | 26 Sep, 2018 | US7312237 |
| Change in Power of Attorney (May Include Associate POA) Critical | 26 Sep, 2018 | US7312237 |
| Email Notification Critical | 26 Sep, 2018 | US7022330 |
| Email Notification Critical | 26 Sep, 2018 | US6670384 |
| Correspondence Address Change Critical | 25 Sep, 2018 | US6670384 |
| Correspondence Address Change Critical | 25 Sep, 2018 | US7125899 |
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 Ixempra Kit and ongoing litigations to help you estimate the early arrival of Ixempra Kit generic.
Ixempra Kit's Litigations
Ixempra Kit been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 30, 2007, against patent number US7312237. The petitioner , challenged the validity of this patent, with Francis Y.F. Lee as the respondent. Click below to track the latest information on how companies are challenging Ixempra Kit's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7312237 | January, 2007 |
Decision
(19 Jun, 2007) | Francis Y.F. Lee | |
FDA has granted some exclusivities to Ixempra Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ixempra 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 Ixempra Kit.
Exclusivity Information
Ixempra Kit holds 3 exclusivities. All of its exclusivities have expired in 2015. Details of Ixempra Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 16, 2012 |
| Pediatric Exclusivity(PED) | Apr 18, 2015 |
| M(M-61) | Oct 18, 2014 |
US patents provide insights into the exclusivity only within the United States, but Ixempra 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 Ixempra Kit's family patents as well as insights into ongoing legal events on those patents.
Ixempra Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ixempra Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 21, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ixempra Kit Generics:
There are no approved generic versions for Ixempra Kit as of now.
How can I launch a generic of Ixempra Kit before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ixempra Kit's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ixempra 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 Ixempra Kit -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg/vial and 45 mg/vial, single- use vials | 16 Apr, 2012 | 1 | 08 Feb, 2022 | Extinguished |
About Ixempra Kit
Ixempra Kit is a drug owned by R-Pharm Us Llc. It is used for treating cancer, specifically breast cancer, by administering Ixabepilone in various formulations and regimens including intravenous administration and combination therapy with Capecitabine. Ixempra Kit uses Ixabepilone as an active ingredient. Ixempra Kit was launched by R-Pharm Us Llc in 2007.
Approval Date:
Ixempra Kit was approved by FDA for market use on 16 October, 2007.
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 Ixempra Kit is 16 October, 2007, its NCE-1 date is estimated to be 18 April, 2014.
Active Ingredient:
Ixempra Kit uses Ixabepilone as the active ingredient. Check out other Drugs and Companies using Ixabepilone ingredient
Treatment:
Ixempra Kit is used for treating cancer, specifically breast cancer, by administering Ixabepilone in various formulations and regimens including intravenous administration and combination therapy with Capecitabine.
Dosage:
Ixempra Kit is available in injectable form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 45MG/VIAL | INJECTABLE | Prescription | INTRAVENOUS |
| 15MG/VIAL | INJECTABLE | Prescription | INTRAVENOUS |