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.
Latest 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 |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 04 Feb, 2003 | US6514953 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Feb, 2003 | US6514953 |
| Issue Notification Mailed Critical | 16 Jan, 2003 | US6514953 |
| Receipt into Pubs | 07 Jan, 2003 | US6514953 |
| Receipt into Pubs | 20 Dec, 2002 | US6514953 |
| Application Is Considered Ready for Issue Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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
Explore Our Curated Drug Screens
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 |
| |||||||||||||||
| Agouron Pharms |
| |||||||||||||||
| Bristol Myers Squibb |
| |||||||||||||||
| Gilead |
| |||||||||||||||
| Gilead Sciences |
| |||||||||||||||
| Gilead Sciences Inc |
| |||||||||||||||
| Glaxosmithkline |
| |||||||||||||||
| Msd Sub Merck |
| |||||||||||||||
| Viiv Hlthcare |
| |||||||||||||||
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 |