Complera Patent Expiration

Complera is a drug owned by Gilead Sciences Inc. It is protected by 28 US drug patents filed from 2013 to 2021. Out of these, 3 drug patents are active and 25 have expired. Complera's patents have been open to challenges since 21 May, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 14, 2033. Details of Complera's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7125879 HIV inhibiting pyrimidines derivatives
Apr, 2025

(6 months from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10857102 Therapeutic compositions comprising rilpivirine HCL and tenofovir disoproxil fumarate
Jan, 2033

(8 years from now)

Active
US8841310 Combinations of a pyrimidine containing NNRTI with RT inhibitors
Dec, 2025

(1 year, 1 month from now)

Active
US8716264

(Pediatric)

Compositions and methods for combination antiviral therapy
Jul, 2024

(3 months ago)

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

(9 months ago)

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

(9 months ago)

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

(9 months ago)

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

(9 months ago)

Expired
US8080551 HIV inhibiting pyrimidines derivatives
Apr, 2023

(1 year, 6 months ago)

Expired
US8101629 Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile
Aug, 2022

(2 years 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
US6838464 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents
Feb, 2021

(3 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
US7067522 2,4,DI (hetero-) arylamino (-oxy)-5-substituted pyrimidines as antineoplastic agents
Dec, 2019

(4 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
US5935946

(Pediatric)

Nucleotide analog composition and synthesis method
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
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
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
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


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 Complera's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 22 May, 2024 US10857102
Expire Patent 22 Jan, 2024 US8080551
Maintenance Fee Reminder Mailed 07 Aug, 2023 US8080551
Payment of Maintenance Fee, 12th Year, Large Entity 12 Jul, 2023 US8101629
Payment of Maintenance Fee, 8th Year, Large Entity 09 Mar, 2022 US8841310 (Litigated)
Post Issue Communication - Certificate of Correction 30 Jun, 2021 US10857102
Withdrawal of Application for PTE 17 Jun, 2021 US8080551
Payment of Maintenance Fee, 8th Year, Large Entity 12 May, 2021 US8592397
Change in Power of Attorney (May Include Associate POA) 25 Mar, 2021 US8080551
Email Notification 25 Mar, 2021 US8080551


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

Complera's Litigations

Complera 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 Complera's patents.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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


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

Exclusivity Information

Complera holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Complera's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) May 20, 2016
New Patient Population(NPP) Dec 13, 2016

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

Complera's Oppositions Filed in EPO

Complera 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
EP04787096A Jan, 2016 Page White & Farrer Limited Patent maintained as amended
EP11791161A Jun, 2015 HGF Limited Patent maintained as amended
EP11791161A Jun, 2015 LEK Pharmaceuticals d.d. Patent maintained as amended
EP05108086A Feb, 2012 Hamm, Volker The patent has been limited
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 Complera 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 Complera's family patents as well as insights into ongoing legal events on those patents.

Complera's Family Patents

Complera has patent protection in a total of 51 countries. It's US patent count contributes only to 14.2% of its total global patent coverage. 8 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 Complera.

Family Patents

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Generic Launch

Generic Release Date:

Complera's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 14, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Complera Generics:

There are no approved generic versions for Complera as of now.

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
200 mg/25 mg/ 300 mg 20 May, 2015 1 09 Dec, 2025

Alternative Brands for Complera

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





About Complera

Complera is a drug owned by Gilead Sciences Inc. It is used for managing and treating HIV infection. Complera uses Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate as an active ingredient. Complera was launched by Gilead Sciences Inc in 2011.

Approval Date:

Complera was approved by FDA for market use on 10 August, 2011.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Complera is 10 August, 2011, its NCE-1 date is estimated to be 21 May, 2015.

Active Ingredient:

Complera uses Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate as the active ingredient. Check out other Drugs and Companies using Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate ingredient

Treatment:

Complera is used for managing and treating HIV infection.

Dosage:

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

Strength Dosage Form Availability Application Pathway
200MG;EQ 25MG BASE;300MG TABLET Prescription ORAL