Intelence is a drug owned by Janssen Research And Development Llc. It is protected by 8 US drug patents filed from 2013 to 2018 out of which all have expired. Intelence's patents have been open to challenges since 16 January, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 16, 2022. Details of Intelence'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). | |||
|
US7037917 (Pediatric) | HIV replication inhibiting pyrimidines |
Jun, 2021
(3 years ago) |
Expired
|
| US7037917 | HIV replication inhibiting pyrimidines |
Dec, 2020
(4 years ago) |
Expired
|
|
US6878717 (Pediatric) | HIV replication inhibiting pyrimidines |
May, 2020
(4 years ago) |
Expired
|
|
US8003789 (Pediatric) | HIV replication inhibiting pyrimidines |
May, 2020
(4 years ago) |
Expired
|
| US6878717 | HIV replication inhibiting pyrimidines |
Nov, 2019
(5 years ago) |
Expired
|
| US8003789 | HIV replication inhibiting pyrimidines |
Nov, 2019
(5 years ago) |
Expired
|
|
US7887845 (Pediatric) | Antiviral compositions |
Sep, 2019
(5 years ago) |
Expired
|
| US7887845 | Antiviral compositions |
Mar, 2019
(5 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 Intelence's patents.
Latest Legal Activities on Intelence's Patents
Given below is the list of recent legal activities going on the following patents of Intelence.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 25 Sep, 2023 | US8003789 |
| Maintenance Fee Reminder Mailed Critical | 10 Apr, 2023 | US8003789 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Nov, 2022 | US7887845 |
| 11.5 yr surcharge- late pmt w/in 6 mo, Large Entity | 16 Nov, 2022 | US7887845 |
| Maintenance Fee Reminder Mailed Critical | 03 Oct, 2022 | US7887845 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Feb, 2019 | US8003789 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Aug, 2018 | US7887845 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Oct, 2017 | US7037917 |
| Post Issue Communication - Certificate of Correction | 26 Aug, 2013 | US7037917 |
| Patent Issue Date Used in PTA Calculation Critical | 23 Aug, 2011 | US8003789 |
FDA has granted several exclusivities to Intelence. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Intelence, 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 Intelence.
Exclusivity Information
Intelence holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Intelence's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 18, 2013 |
| New Patient Population(NPP) | Mar 26, 2015 |
| Pediatric Exclusivity(PED) | Jan 16, 2022 |
US patents provide insights into the exclusivity only within the United States, but Intelence 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 Intelence's family patents as well as insights into ongoing legal events on those patents.
Intelence's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Intelence's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 16, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Intelence Generic API suppliers:
Etravirine is the generic name for the brand Intelence. 2 different companies have already filed for the generic of Intelence, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Intelence's generic
Alternative Brands for Intelence
Intelence which is used for treating HIV-1 infection in patients who are treatment-experienced and have evidence of viral replication and resistance to certain antiretroviral drugs., 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.
About Intelence
Intelence is a drug owned by Janssen Research And Development Llc. It is used for treating HIV-1 infection in patients who are treatment-experienced and have evidence of viral replication and resistance to certain antiretroviral drugs. Intelence uses Etravirine as an active ingredient. Intelence was launched by Janssen R And D in 2012.
Approval Date:
Intelence was approved by FDA for market use on 26 March, 2012.
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 Intelence is 26 March, 2012, its NCE-1 date is estimated to be 16 January, 2021.
Active Ingredient:
Intelence uses Etravirine as the active ingredient. Check out other Drugs and Companies using Etravirine ingredient
Treatment:
Intelence is used for treating HIV-1 infection in patients who are treatment-experienced and have evidence of viral replication and resistance to certain antiretroviral drugs.
Dosage:
Intelence is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |