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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
US8598185 | Unitary pharmaceutical dosage form |
Apr, 2029
(4 years from now) | Active |
US9545414 | Unitary pharmaceutical dosage form |
Jun, 2026
(1 year, 6 months from now) | Active |
US9018192 | Unitary pharmaceutical dosage form |
Jun, 2026
(1 year, 6 months from now) | Active |
US8716264 (Pediatric) | Compositions and methods for combination antiviral therapy |
Jul, 2024
(4 months ago) |
Expired
|
US8716264 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(10 months ago) |
Expired
|
US9744181 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(10 months ago) |
Expired
|
US8592397 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(10 months ago) |
Expired
|
US9457036 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(10 months ago) |
Expired
|
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
|
US6639071 (Pediatric) | Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one |
Aug, 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 | Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one |
Feb, 2018
(6 years ago) |
Expired
|
US5977089 (Pediatric) | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jan, 2018
(6 years ago) |
Expired
|
US6043230 (Pediatric) | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
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
|
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
|
US5914331 (Pediatric) | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Jan, 2018
(6 years ago) |
Expired
|
US5922695 | Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability |
Jul, 2017
(7 years ago) |
Expired
|
US5935946 | Nucleotide analog composition and synthesis method |
Jul, 2017
(7 years ago) |
Expired
|
US6043230 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jul, 2017
(7 years ago) |
Expired
|
US5977089 | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jul, 2017
(7 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
|
US5663169 (Pediatric) | Benzoxazinones as inhibitors of HIV reverse transcriptase |
Mar, 2015
(9 years ago) |
Expired
|
US5663169 | Benzoxazinones as inhibitors of HIV reverse transcriptase |
Sep, 2014
(10 years ago) |
Expired
|
US5519021 (Pediatric) | Benzoxazinones as inhibitors of HIV reverse transcriptase |
Nov, 2013
(11 years ago) |
Expired
|
US5519021 | Benzoxazinones as inhibitors of HIV reverse transcriptase |
May, 2013
(11 years ago) |
Expired
|
US5811423 | Benzoxazinones as inhibitors of HIV reverse transcriptase |
Aug, 2012
(12 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 Atripla's patents.
Latest Legal Activities on Atripla's Patents
Given below is the list of recent legal activities going on the following patents of Atripla.
Activity | Date | Patent Number |
---|---|---|
Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jul, 2024 | US9545414 |
Payment of Maintenance Fee, 8th Year, Large Entity | 12 Oct, 2022 | US9018192 |
Payment of Maintenance Fee, 8th Year, Large Entity | 19 May, 2021 | US8598185 |
Payment of Maintenance Fee, 8th Year, Large Entity | 12 May, 2021 | US8592397 |
Payment of Maintenance Fee, 4th Year, Large Entity | 10 Feb, 2021 | US9744181 |
Payment of Maintenance Fee, 4th Year, Large Entity | 02 Jul, 2020 | US9545414 |
Payment of Maintenance Fee, 4th Year, Large Entity | 29 Oct, 2018 | US9018192 |
Patent Issue Date Used in PTA Calculation Critical | 29 Aug, 2017 | US9744181 |
Recordation of Patent Grant Mailed Critical | 29 Aug, 2017 | US9744181 |
Email Notification Critical | 10 Aug, 2017 | US9744181 |
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 Atripla and ongoing litigations to help you estimate the early arrival of Atripla generic.
Atripla's Litigations
Atripla 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 Atripla's patents.
Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
---|---|---|---|---|
US5935946 | June, 2014 |
Terminated-Denied
(17 Dec, 2014) | Gilead Sciences, Inc. | MYLAN PHARMACEUTICALS INC. |
US5922695 | June, 2014 |
Terminated-Denied
(09 Dec, 2014) | Gilead Sciences, Inc. | Mylan Pharmaceuticals Inc. |
US5977089 | June, 2014 |
Terminated-Denied
(09 Dec, 2014) | Gilead Sciences, Inc. | Mylan Pharmaceuticals Inc. |
US6043230 | June, 2014 |
Terminated-Denied
(09 Dec, 2014) | Gilead Sciences, Inc. | Mylan Pharmaceuticals Inc. |
US6703396 | April, 2002 |
Decision
(04 Apr, 2002) | DIONNE | |
US6642245 | July, 2001 |
Decision
(05 Jul, 2001) | DIONNE |
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 |
---|---|---|---|
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate is the generic name for the brand Atripla. 8 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 |
Alternative Brands for Atripla
Atripla which is used for managing HIV-1 infection in adults and pediatric patients aged 12 years and older., 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 |
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Agouron Pharms |
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Bristol Myers Squibb |
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Gilead |
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Gilead Sciences Inc |
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Glaxosmithkline |
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Msd Sub Merck |
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Viiv Hlthcare |
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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.
Approval 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 | Discontinued | ORAL |