Emtriva Patent Expiration

Emtriva is a drug owned by Gilead Sciences Inc. It is protected by 8 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 Sep 09, 2021. Details of Emtriva'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).
US6703396

(Pediatric)

Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Sep, 2021

(3 years ago)

Expired
US6642245

(Pediatric)

Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
May, 2021

(3 years ago)

Expired
US6703396 Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Mar, 2021

(3 years ago)

Expired
US6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Nov, 2020

(4 years ago)

Expired
US5914331

(Pediatric)

Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Jan, 2018

(6 years ago)

Expired
US5914331 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Jul, 2017

(7 years ago)

Expired
US5814639

(Pediatric)

Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds
Mar, 2016

(8 years ago)

Expired
US5814639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds
Sep, 2015

(9 years ago)

Expired


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

Emtriva's Litigations

Emtriva been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 05, 2001, against patent number US6642245. The petitioner , challenged the validity of this patent, with DIONNE as the respondent. Click below to track the latest information on how companies are challenging Emtriva's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6703396 April, 2002 Decision
(04 Apr, 2002)
DIONNE
US6642245 July, 2001 Decision
(05 Jul, 2001)
DIONNE

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

Emtriva's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Emtriva's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 09, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Emtriva Generic API suppliers:

Emtricitabine is the generic name for the brand Emtriva. 2 different companies have already filed for the generic of Emtriva, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Emtriva's generic

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
200 mg 16 Jul, 2012 1 02 Jul, 2018 09 Mar, 2021 Eligible

Alternative Brands for Emtriva

Emtriva which is used for treating HIV infection in adults., has several other brand drugs in the same treatment category and using the same active ingredient (Emtricitabine). 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
Truvada

(uses Emtricitabine)

Used for treating HIV-1 infection in adults and pediatric patients.
Gilead Sciences
Atripla

(uses Emtricitabine)

Used for managing HIV-1 infection in adults and pediatric patients aged 12 years and older.
Gilead Sciences Inc
Descovy

(uses Emtricitabine)

Used for managing and treating HIV infection.
Genvoya

(uses Emtricitabine)

Used for treating HIV infection with a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monoxygenase.
Odefsey

(uses Emtricitabine)

Used for treating HIV infection.
Vitekta Used for managing HIV infection.
Biktarvy

(uses Emtricitabine)

Used for treating HIV infection.
Complera

(uses Emtricitabine)

Used for managing and treating HIV infection.
Stribild

(uses Emtricitabine)

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.
Lexiva Used for managing and treating HIV infection.
Epzicom Used for treating HIV infection.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Emtricitabine. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Janssen Prods
Symtuza


Apart from brand drugs containing the same ingredient, some generics have also been filed for Emtricitabine, Emtriva's active ingredient. Check the complete list of approved generic manufacturers for Emtriva





About Emtriva

Emtriva is a drug owned by Gilead Sciences Inc. It is used for treating HIV infection in adults. Emtriva uses Emtricitabine as an active ingredient. Emtriva was launched by Gilead in 2003.

Approval Date:

Emtriva was approved by FDA for market use on 02 July, 2003.

Active Ingredient:

Emtriva uses Emtricitabine as the active ingredient. Check out other Drugs and Companies using Emtricitabine ingredient

Treatment:

Emtriva is used for treating HIV infection in adults.

Dosage:

Emtriva is available in the following dosage forms - solution form for oral use, capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG CAPSULE Prescription ORAL
10MG/ML SOLUTION Prescription ORAL