Aloxi Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Aloxi.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 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.

Last updated on December 24, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

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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
Patent litigations
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

Aloxi has patent protection in a total of 40 countries. It's US patent count contributes only to 29.9% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Aloxi.

Family Patents

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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
Akynzeo

(uses Palonosetron Hydrochloride)

Used for preventing chemotherapy-induced nausea and vomiting in adults.
Merck
Emend Used for preventing and treating nausea and vomiting associated with chemotherapy, postoperative nausea and vomiting, and emesis induced by cancer chemotherapeutic agents.

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