Aloxi is a drug owned by Helsinn Healthcare Sa. It is protected by 28 US drug patents filed from 2013 to 2017 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 30, 2024. Details of Aloxi'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). | |||
US9457021 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US9457020 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US9439854 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US8598219 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US9066980 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US7947724 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US7947725 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US7960424 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US8729094 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US8518981 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US8598218 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US9173942 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US9125905 (Pediatric) | Liquid pharmaceutical formulations of palonosetron |
Jul, 2024
(4 months ago) |
Expired
|
US9173942 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US7947724 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US8598219 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US9066980 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US8729094 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US9457021 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US7947725 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US7960424 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US8518981 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US9125905 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US9439854 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US8598218 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US9457020 | Liquid pharmaceutical formulations of palonosetron |
Jan, 2024
(10 months ago) |
Expired
|
US5202333 (Pediatric) | Tricyclic 5-HT3 receptor antagonists |
Oct, 2015
(9 years ago) |
Expired
|
US5202333 | Tricyclic 5-HT3 receptor antagonists |
Apr, 2015
(9 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 Aloxi's patents.
Latest Legal Activities on Aloxi's Patents
Given below is the list of recent legal activities going on the following patents of Aloxi.
Activity | Date | Patent Number |
---|---|---|
Maintenance Fee Reminder Mailed Critical | 27 May, 2024 | US9457020 |
Payment of Maintenance Fee, 8th Year, Large Entity | 22 Feb, 2023 | US9125905 (Litigated) |
Payment of Maintenance Fee, 8th Year, Large Entity | 16 Nov, 2022 | US9066980 (Litigated) |
Payment of Maintenance Fee, 12th Year, Large Entity | 16 Nov, 2022 | US7960424 (Litigated) |
Payment of Maintenance Fee, 12th Year, Large Entity | 20 Oct, 2022 | US7947724 (Litigated) |
Payment of Maintenance Fee, 12th Year, Large Entity | 20 Oct, 2022 | US7947725 (Litigated) |
Payment of Maintenance Fee, 8th Year, Large Entity | 20 May, 2021 | US8598218 (Litigated) |
Payment of Maintenance Fee, 8th Year, Large Entity | 20 May, 2021 | US8598219 (Litigated) |
Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jan, 2021 | US8518981 (Litigated) |
Payment of Maintenance Fee, 4th Year, Large Entity | 17 Mar, 2020 | US9457020 |
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 Aloxi and ongoing litigations to help you estimate the early arrival of Aloxi generic.
Aloxi's Litigations
Aloxi been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 02, 2014, against patent number US8598219. The petitioner Accord Healthcare, Inc., challenged the validity of this patent, with Helsinn Healthcare S.A. as the respondent. Click below to track the latest information on how companies are challenging Aloxi's patents.
Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
---|---|---|---|---|
US9173942 | February, 2016 |
Terminated-Denied
(17 Aug, 2016) | Helsinn Healthcare S.A. | Dr. Reddy's Laboratories, Ltd |
US8729094 | July, 2015 |
Terminated-Denied
(14 Oct, 2015) | Helsinn Healthcare S.A. | Dr. Reddy's Laboratories, Ltd |
US8729094 | July, 2015 |
Terminated-Denied
(14 Oct, 2015) | Helsinn Healthcare S.A. | Dr. Reddy's Laboratories, Ltd. |
US8598219 | September, 2014 |
Terminated-Denied
(24 Nov, 2014) | Helsinn Healthcare S.A. | Accord Healthcare, Inc. |
FDA has granted some exclusivities to Aloxi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aloxi, 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 Aloxi.
Exclusivity Information
Aloxi holds 4 exclusivities. All of its exclusivities have expired in 2017. Details of Aloxi's exclusivity codes and their expiration dates are given below.
Drug Exclusivity | Drug Exclusivity Expiration |
---|---|
New Dosage Form(NDF) | Aug 22, 2011 |
New Indication(I-684) | May 27, 2017 |
M(M-136) | May 27, 2017 |
Pediatric Exclusivity(PED) | Nov 27, 2017 |
Several oppositions have been filed on Aloxi'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 Aloxi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Aloxi patents.
Aloxi's Oppositions Filed in EPO
Aloxi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 08, 2009, by Tecnimede Sociedade Tecnico-Medicinal, S.A.. This opposition was filed on patent number EP04706657A. Click below to reveal the latest opposition data.
Application | Filing Date | Opposition Party | Legal Status |
---|---|---|---|
EP04706657A | Jul, 2009 | DR REDDYS LABORATORIES (UK) LIMITED | Revoked |
EP04706657A | Jul, 2009 | White, Martin Paul | Revoked |
EP04706657A | Jul, 2009 | Tecnimede Sociedade Tecnico-Medicinal, S.A. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Aloxi 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 Aloxi's family patents as well as insights into ongoing legal events on those patents.
Aloxi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aloxi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 30, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aloxi Generic API suppliers:
Palonosetron Hydrochloride is the generic name for the brand Aloxi. 16 different companies have already filed for the generic of Aloxi, with Teva Pharms Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aloxi's generic
How can I launch a generic of Aloxi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aloxi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aloxi'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 Aloxi -
Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
---|---|---|---|---|---|
0.05 mg/mL, 1.5 mL and 5 mL vials | 27 May, 2011 | 3 | 13 Oct, 2015 | 13 Apr, 2015 | Extinguished |
Alternative Brands for Aloxi
Aloxi which is used for preventing nausea and vomiting caused by chemotherapy and postoperative procedures., has several other brand drugs in the same treatment category and using the same active ingredient (Palonosetron 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 | ||
---|---|---|---|---|
Helsinn Hlthcare |
| |||
Merck |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Palonosetron Hydrochloride, Aloxi's active ingredient. Check the complete list of approved generic manufacturers for Aloxi
About Aloxi
Aloxi is a drug owned by Helsinn Healthcare Sa. It is used for preventing nausea and vomiting caused by chemotherapy and postoperative procedures. Aloxi uses Palonosetron Hydrochloride as an active ingredient. Aloxi was launched by Helsinn Hlthcare in 2008.
Approval Date:
Aloxi was approved by FDA for market use on 29 February, 2008.
Active Ingredient:
Aloxi uses Palonosetron Hydrochloride as the active ingredient. Check out other Drugs and Companies using Palonosetron Hydrochloride ingredient
Treatment:
Aloxi is used for preventing nausea and vomiting caused by chemotherapy and postoperative procedures.
Dosage:
Aloxi is available in the following dosage forms - injectable form for intravenous use, capsule form for oral use. Given below is detailed information on Dosage -
Strength | Dosage Form | Availability | Application Pathway |
---|---|---|---|
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INTRAVENOUS |
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INTRAVENOUS |
EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |