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, 2 drug patents are active and 26 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
(18 days ago) |
Expired
|
| 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
(7 years from now) | Active |
| US8841310 | Combinations of a pyrimidine containing NNRTI with RT inhibitors |
Dec, 2025
(6 months from now) | Active |
|
US8716264 (Pediatric) | Compositions and methods for combination antiviral therapy |
Jul, 2024
(9 months ago) |
Expired
|
| US9744181 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US8716264 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US9457036 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US8592397 | Compositions and methods for combination antiviral therapy |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US8080551 | HIV inhibiting pyrimidines derivatives |
Apr, 2023
(2 years 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
(4 years ago) |
Expired
|
| US6703396 | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Mar, 2021
(4 years ago) |
Expired
|
| US6838464 | 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents |
Feb, 2021
(4 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
|
| US7067522 | 2,4,DI (hetero-) arylamino (-oxy)-5-substituted pyrimidines as antineoplastic agents |
Dec, 2019
(5 years ago) |
Expired
|
|
US5922695 (Pediatric) | Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability |
Jan, 2018
(7 years ago) |
Expired
|
|
US6043230 (Pediatric) | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jan, 2018
(7 years ago) |
Expired
|
|
US5977089 (Pediatric) | Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability |
Jan, 2018
(7 years ago) |
Expired
|
|
US5935946 (Pediatric) | Nucleotide analog composition and synthesis method |
Jan, 2018
(7 years ago) |
Expired
|
|
US5914331 (Pediatric) | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Jan, 2018
(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
|
| 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
(9 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.
Latest 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 |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 May, 2024 | US10857102 |
| Expire Patent Critical | 22 Jan, 2024 | US8080551 |
| Maintenance Fee Reminder Mailed Critical | 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 Critical | 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) Critical | 25 Mar, 2021 | US8080551 |
| Email Notification Critical | 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.
| 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 | |
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 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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 |
| |||||||||||||
| Agouron Pharms |
| |||||||||||||
| Bristol Myers Squibb |
| |||||||||||||
| Gilead |
| |||||||||||||
| Gilead Sciences |
| |||||||||||||
| Gilead Sciences Inc |
| |||||||||||||
| Glaxosmithkline |
| |||||||||||||
| Msd Sub Merck |
| |||||||||||||
| Viiv Hlthcare |
| |||||||||||||
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 |