Selzentry is a drug owned by Viiv Healthcare Co. It is protected by 7 US drug patents filed from 2016 to 2020 out of which all have expired. Selzentry's patents have been open to challenges since 07 August, 2011. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 30, 2024. Details of Selzentry'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. | |||
| US6667314 | Tropane derivatives useful in therapy |
Aug, 2021
(3 years ago) |
Expired
|
| US7576097 | Tropane derivatives useful in therapy |
May, 2021
(4 years ago) |
Expired
|
| US6586430 | CCR5 modulators |
Dec, 2019
(5 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7368460 (Pediatric) | Tropane derivatives useful in therapy |
May, 2023
(2 years ago) |
Expired
|
| US7368460 | Tropane derivatives useful in therapy |
Nov, 2022
(2 years ago) |
Expired
|
|
US6667314 (Pediatric) | Tropane derivatives useful in therapy |
Feb, 2022
(3 years ago) |
Expired
|
|
US7576097 (Pediatric) | Tropane derivatives useful in therapy |
Nov, 2021
(3 years ago) |
Expired
|
| US6667314 | Tropane derivatives useful in therapy |
Aug, 2021
(3 years ago) |
Expired
|
| US7576097 | Tropane derivatives useful in therapy |
May, 2021
(4 years ago) |
Expired
|
| US6586430 | CCR5 modulators |
Dec, 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 Selzentry's patents.
Latest Legal Activities on Selzentry's Patents
Given below is the list of recent legal activities going on the following patents of Selzentry.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Sep, 2020 | US7576097 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Oct, 2019 | US7368460 |
| Patent Term Extension Application under 35 USC 156 Filed | 16 Jun, 2010 | US6667314 |
| Notice of Final Determination -Eligible | 23 Feb, 2010 | US6667314 |
| FDA Final Eligibility Letter Critical | 30 Sep, 2009 | US6667314 |
| Patent Issue Date Used in PTA Calculation Critical | 18 Aug, 2009 | US7576097 |
| Recordation of Patent Grant Mailed Critical | 18 Aug, 2009 | US7576097 |
| Email Notification Critical | 30 Jul, 2009 | US7576097 |
| Issue Notification Mailed Critical | 29 Jul, 2009 | US7576097 |
| Application Is Considered Ready for Issue Critical | 16 Jul, 2009 | US7576097 |
FDA has granted several exclusivities to Selzentry. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Selzentry, 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 Selzentry.
Exclusivity Information
Selzentry holds 5 exclusivities. All of its exclusivities have expired in 2024. Details of Selzentry's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 06, 2012 |
| New Patient Population(NPP) | Oct 30, 2023 |
| New Product(NP) | Nov 04, 2019 |
| New Strength(NS) | Nov 04, 2019 |
| Pediatric Exclusivity(PED) | Apr 30, 2024 |
US patents provide insights into the exclusivity only within the United States, but Selzentry 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 Selzentry's family patents as well as insights into ongoing legal events on those patents.
Selzentry's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Selzentry's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 30, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Selzentry Generic API suppliers:
Maraviroc is the generic name for the brand Selzentry. 3 different companies have already filed for the generic of Selzentry, with Hetero Labs Ltd Iii having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Selzentry's generic
How can I launch a generic of Selzentry before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Selzentry's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Selzentry'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 Selzentry -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg and 300 mg | 08 Aug, 2011 | 2 | 07 Feb, 2022 | 25 Nov, 2022 | Eligible |
About Selzentry
Selzentry is a drug owned by Viiv Healthcare Co. It is used for treating patients infected with CCR5-tropic HIV-1. Selzentry uses Maraviroc as an active ingredient. Selzentry was launched by Viiv Hlthcare in 2016.
Approval Date:
Selzentry was approved by FDA for market use on 04 November, 2016.
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 Selzentry is 04 November, 2016, its NCE-1 date is estimated to be 07 August, 2011.
Active Ingredient:
Selzentry uses Maraviroc as the active ingredient. Check out other Drugs and Companies using Maraviroc ingredient
Treatment:
Selzentry is used for treating patients infected with CCR5-tropic HIV-1.
Dosage:
Selzentry is available in the following dosage forms - solution form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 150MG | TABLET | Prescription | ORAL |
| 300MG | TABLET | Prescription | ORAL |
| 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 20MG/ML | SOLUTION | Prescription | ORAL |