Edurant is a drug owned by Janssen Products Lp. It is protected by 7 US drug patents filed from 2013 to 2024. Out of these, 2 drug patents are active and 5 have expired. Edurant'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 Oct 21, 2025. Details of Edurant'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
(5 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). | |||
|
US7125879 (Pediatric) | HIV inhibiting pyrimidines derivatives |
Oct, 2025
(11 months from now) | Active |
| US7638522 | Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino] benzonitrile |
Apr, 2023
(1 year, 7 months ago) |
Expired
|
| US8080551 | HIV inhibiting pyrimidines derivatives |
Apr, 2023
(1 year, 7 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
|
| US6838464 | 2,4-Di(hetero-)arylamino(-oxy)-5-substituted pyrimidines as antineaoplastic agents |
Feb, 2021
(3 years ago) |
Expired
|
| US7067522 | 2,4,DI (hetero-) arylamino (-oxy)-5-substituted pyrimidines as antineoplastic agents |
Dec, 2019
(4 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 Edurant's patents.
Latest Legal Activities on Edurant's Patents
Given below is the list of recent legal activities going on the following patents of Edurant.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 |
| Withdrawal of Application for PTE Critical | 17 Jun, 2021 | US8080551 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Jun, 2021 | US7638522 |
| Email Notification Critical | 25 Mar, 2021 | US8080551 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Mar, 2021 | US8080551 |
| Correspondence Address Change Critical | 23 Mar, 2021 | US8080551 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jul, 2019 | US8101629 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Jun, 2019 | US8080551 |
FDA has granted several exclusivities to Edurant. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Edurant, 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 Edurant.
Exclusivity Information
Edurant holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Edurant'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) | Aug 26, 2018 |
| M(M-223) | Feb 01, 2021 |
Several oppositions have been filed on Edurant'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 Edurant's generic, the next section provides detailed information on ongoing and past EP oppositions related to Edurant patents.
Edurant's Oppositions Filed in EPO
Edurant has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 09, 2012, by Hamm, Volker. This opposition was filed on patent number EP05108086A. 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 |
| EP05108086A | Feb, 2012 | Hamm, Volker | The patent has been limited |
US patents provide insights into the exclusivity only within the United States, but Edurant 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 Edurant's family patents as well as insights into ongoing legal events on those patents.
Edurant's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Edurant's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 21, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Edurant Generics:
There are no approved generic versions for Edurant as of now.
Alternative Brands for Edurant
Edurant which is used for treating HIV-1 infection in treatment-naive adult patients with low viral load., has several other brand drugs using the same active ingredient (Rilpivirine Hydrochloride). 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 | ||
|---|---|---|---|
| Gilead Sciences Inc |
| ||
| Janssen Prods |
| ||
| Viiv Hlthcare |
|
About Edurant
Edurant is a drug owned by Janssen Products Lp. It is used for treating HIV-1 infection in treatment-naive adult patients with low viral load. Edurant uses Rilpivirine Hydrochloride as an active ingredient. Edurant was launched by Janssen Prods in 2011.
Approval Date:
Edurant was approved by FDA for market use on 20 May, 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 Edurant is 20 May, 2011, its NCE-1 date is estimated to be 21 May, 2015.
Active Ingredient:
Edurant uses Rilpivirine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Rilpivirine Hydrochloride ingredient
Treatment:
Edurant is used for treating HIV-1 infection in treatment-naive adult patients with low viral load.
Dosage:
Edurant is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG BASE | TABLET | Prescription | ORAL |