Lexiva Patent Expiration

Lexiva is a drug owned by Viiv Healthcare Co. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 15, 2020. Details of Lexiva'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).
US6514953

(Pediatric)

Calcium (3S) tetrahydro-3-furanyl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy)propylcarbamate
Jan, 2020

(4 years ago)

Expired
US6514953 Calcium (3S) tetrahydro-3-furanyl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy)propylcarbamate
Jul, 2019

(5 years ago)

Expired
US6436989

(Pediatric)

Prodrugs of aspartyl protease inhibitors
Jun, 2018

(6 years ago)

Expired
US6436989 Prodrugs of aspartyl protease inhibitors
Dec, 2017

(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 Lexiva's patents.

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

Activity Date Patent Number
Patent litigations
Recordation of Patent Grant Mailed 04 Feb, 2003 US6514953
Patent Issue Date Used in PTA Calculation 04 Feb, 2003 US6514953
Issue Notification Mailed 16 Jan, 2003 US6514953
Receipt into Pubs 07 Jan, 2003 US6514953
Receipt into Pubs 20 Dec, 2002 US6514953
Application Is Considered Ready for Issue 17 Dec, 2002 US6514953
Receipt into Pubs 04 Dec, 2002 US6514953
Workflow - Customer Service Request - Finish 27 Nov, 2002 US6514953
Workflow - Customer Service Request - Begin 27 Nov, 2002 US6514953
Workflow - Drawings Received at Contractor 25 Nov, 2002 US6514953


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 Lexiva and ongoing litigations to help you estimate the early arrival of Lexiva generic.

Lexiva's Litigations

Lexiva been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 18, 2012, against patent number US6436989. The petitioner Ranbaxy Laboratories Ltd. et al., challenged the validity of this patent, with Vertex Pharmaceuticals Incorporated as the respondent. Click below to track the latest information on how companies are challenging Lexiva's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6436989 February, 2016 FWD Entered
(28 Jul, 2017)
Vertex Pharmaceuticals Incorporated Lupin Limited
US6436989 December, 2014 Terminated-Settled
(03 Nov, 2015)
Vertex Pharmaceuticals Incorporated Lupin Limited
US6436989 October, 2012 Terminated-Settled
(15 Nov, 2013)
Vertex Pharmaceuticals Incorporated Ranbaxy Laboratories Ltd. et al.


FDA has granted some exclusivities to Lexiva. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lexiva, 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 Lexiva.

Exclusivity Information

Lexiva holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Lexiva's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Apr 27, 2015
Pediatric Exclusivity(PED) Oct 27, 2015

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Lexiva 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 Lexiva's family patents as well as insights into ongoing legal events on those patents.

Lexiva's Family Patents


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Lexiva's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 15, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Lexiva Generic API suppliers:

Fosamprenavir Calcium is the generic name for the brand Lexiva. 2 different companies have already filed for the generic of Lexiva, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lexiva's generic

How can I launch a generic of Lexiva before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Lexiva's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lexiva'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 Lexiva -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
700 mg 18 Jan, 2012 1 20 Nov, 2019 15 Jul, 2019 Extinguished

Alternative Brands for Lexiva

Lexiva which is used for managing and treating HIV infection., 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
Abbvie
Kaletra used for treating HIV-1 infection in combination with other antiretroviral agents.
Agouron Pharms
Viracept Used for managing HIV infection.
Bristol Myers Squibb
Sustiva used for managing HIV infection in combination with other antiviral drugs.
Gilead
Emtriva Used for treating HIV infection in adults.
Truvada Used for treating HIV-1 infection in adults and pediatric patients.
Gilead Sciences
Atripla Used for managing HIV-1 infection in adults and pediatric patients aged 12 years and older.
Gilead Sciences Inc
Descovy Used for managing and treating HIV infection.
Genvoya Used for treating HIV infection with a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monoxygenase.
Odefsey Used for treating HIV infection.
Vitekta Used for managing HIV infection.
Biktarvy Used for treating HIV infection.
Complera Used for managing and treating HIV infection.
Stribild Used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase.
Glaxosmithkline
Agenerase Used for managing HIV infection.
Msd Sub Merck
Isentress Used for treating HIV infection by inhibiting integrase.
Isentress Hd Used for treating HIV infection.
Viiv Hlthcare
Dovato Used for the treatment of HIV infection.
Juluca Used for managing HIV infection.
Epzicom Used for treating HIV infection.





About Lexiva

Lexiva is a drug owned by Viiv Healthcare Co. It is used for managing and treating HIV infection. Lexiva uses Fosamprenavir Calcium as an active ingredient. Lexiva was launched by Viiv Hlthcare in 2003.

Approval Date:

Lexiva was approved by FDA for market use on 20 October, 2003.

Active Ingredient:

Lexiva uses Fosamprenavir Calcium as the active ingredient. Check out other Drugs and Companies using Fosamprenavir Calcium ingredient

Treatment:

Lexiva is used for managing and treating HIV infection.

Dosage:

Lexiva is available in the following dosage forms - tablet form for oral use, suspension form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 700MG BASE TABLET Discontinued ORAL
EQ 50MG BASE/ML SUSPENSION Discontinued ORAL