Atripla Patent Expiration

Atripla is a drug owned by Gilead Sciences Llc. It is protected by 33 US drug patents filed from 2013 to 2017. Out of these, 3 drug patents are active and 30 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 28, 2029. Details of Atripla'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5811423 Benzoxazinones as inhibitors of HIV reverse transcriptase
Aug, 2012

(11 years ago)

Expired
US5519021 Benzoxazinones as inhibitors of HIV reverse transcriptase
May, 2013

(11 years ago)

Expired
US5519021

(Pediatric)

Benzoxazinones as inhibitors of HIV reverse transcriptase
Nov, 2013

(10 years ago)

Expired
US5663169 Benzoxazinones as inhibitors of HIV reverse transcriptase
Sep, 2014

(9 years ago)

Expired
US5663169

(Pediatric)

Benzoxazinones as inhibitors of HIV reverse transcriptase
Mar, 2015

(9 years ago)

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

(8 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
US5914331 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Jul, 2017

(7 years ago)

Expired
US5922695 Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
Jul, 2017

(6 years ago)

Expired
US5935946 Nucleotide analog composition and synthesis method
Jul, 2017

(6 years ago)

Expired
US6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Jul, 2017

(6 years ago)

Expired
US5977089 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Jul, 2017

(6 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
US6939964 Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Jan, 2018

(6 years ago)

Expired
US5935946

(Pediatric)

Nucleotide analog composition and synthesis method
Jan, 2018

(6 years ago)

Expired
US5922695

(Pediatric)

Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
Jan, 2018

(6 years ago)

Expired
US6043230

(Pediatric)

Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Jan, 2018

(6 years ago)

Expired
US5977089

(Pediatric)

Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Jan, 2018

(6 years ago)

Expired
US6639071 Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Feb, 2018

(6 years ago)

Expired
US6939964

(Pediatric)

Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Jul, 2018

(6 years ago)

Expired
US6639071

(Pediatric)

Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Aug, 2018

(5 years ago)

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

(3 years ago)

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

(Pediatric)

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

(2 years ago)

Expired
US8592397 Compositions and methods for combination antiviral therapy
Jan, 2024

(6 months ago)

Expired
US9457036 Compositions and methods for combination antiviral therapy
Jan, 2024

(6 months ago)

Expired
US9744181 Compositions and methods for combination antiviral therapy
Jan, 2024

(6 months ago)

Expired
US8716264 Compositions and methods for combination antiviral therapy
Jan, 2024

(6 months ago)

Expired
US8716264

(Pediatric)

Compositions and methods for combination antiviral therapy
Jul, 2024

(15 days ago)

Expired
US9018192 Unitary pharmaceutical dosage form
Jun, 2026

(1 year, 10 months from now)

Active
US9545414 Unitary pharmaceutical dosage form
Jun, 2026

(1 year, 10 months from now)

Active
US8598185 Unitary pharmaceutical dosage form
Apr, 2029

(4 years from now)

Active

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Several oppositions have been filed on Atripla'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 Atripla's generic, the next section provides detailed information on ongoing and past EP oppositions related to Atripla patents.

Atripla's oppositions filed in EPO

Atripla has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 13, 2009, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP04701819A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP11167101A Dec, 2015 Hetero Drugs Ltd. Revoked
EP11167101A Dec, 2015 Sandoz AG Revoked
EP11167101A Dec, 2015 Accord Healthcare Ltd Revoked
EP11167101A Dec, 2015 KELTIE LLP Revoked
EP11167101A Dec, 2015 Strawman Limited Revoked
EP06773194A Oct, 2009 Teva Pharmaceutical Industries Ltd. Revoked
EP04701819A Mar, 2009 Generics [UK] Limited Revoked
EP04701819A Mar, 2009 Teva Pharmaceutical Industries LTD. Revoked


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

Atripla's family patents

Atripla has patent protection in a total of 31 countries. It's US patent count contributes only to 21.3% of its total global patent coverage. 3 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 Atripla.

Family Patents

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Generic Launch

Generic Release Date:

Atripla's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 28, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Atripla Generics:

Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate is the generic name for the brand Atripla. 7 different companies have already filed for the generic of Atripla, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Atripla's generic

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
600 mg/200 mg/300 mg 29 Dec, 2008 1 09 Nov, 2018 09 Mar, 2021 Extinguished




About Atripla

Atripla is a drug owned by Gilead Sciences Llc. It is used for managing HIV-1 infection in adults and pediatric patients aged 12 years and older. Atripla uses Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate as an active ingredient. Atripla was launched by Gilead Sciences in 2006.

Market Authorisation Date:

Atripla was approved by FDA for market use on 12 July, 2006.

Active Ingredient:

Atripla uses Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate as the active ingredient. Check out other Drugs and Companies using Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate ingredient

Treatment:

Atripla is used for managing HIV-1 infection in adults and pediatric patients aged 12 years and older.

Dosage:

Atripla is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
600MG;200MG;300MG TABLET Prescription ORAL