Prezista is a drug owned by Janssen Products Lp. It is protected by 26 US drug patents filed from 2013 to 2019. Out of these, 2 drug patents are active and 24 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 26, 2027. Details of Prezista'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. | |||
| US7700645 | Pseudopolymorphic forms of a HIV protease inhibitor |
Dec, 2026
(1 year, 7 months from now) | Active |
| US8518987 | Pseudopolymorphic forms of a HIV protease inhibitor |
Feb, 2024
(1 year, 2 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7700645 (Pediatric) | Pseudopolymorphic forms of a HIV protease inhibitor |
Jun, 2027
(2 years from now) | Active |
|
US8518987 (Pediatric) | Pseudopolymorphic forms of a HIV protease inhibitor |
Aug, 2024
(8 months ago) |
Expired
|
|
US9889115 (Pediatric) | Fitness assay and associated methods |
Dec, 2019
(5 years ago) |
Expired
|
|
US7470506 (Pediatric) | Fitness assay and associated methods |
Dec, 2019
(5 years ago) |
Expired
|
|
US8597876 (Pediatric) | Method of treating HIV infection |
Dec, 2019
(5 years ago) |
Expired
|
| US8597876 | Method of treating HIV infection |
Jun, 2019
(5 years ago) |
Expired
|
| US9889115 | Fitness assay and associated methods |
Jun, 2019
(5 years ago) |
Expired
|
| US7470506 | Fitness assay and associated methods |
Jun, 2019
(5 years ago) |
Expired
|
|
USRE43596 (Pediatric) | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Nov, 2017
(7 years ago) |
Expired
|
| USRE43596 | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
May, 2017
(8 years ago) |
Expired
|
|
USRE43802 (Pediatric) | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Apr, 2017
(8 years ago) |
Expired
|
|
USRE42889 (Pediatric) | α- and β- amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Apr, 2017
(8 years ago) |
Expired
|
|
US6037157 (Pediatric) | Method for improving pharmacokinetics |
Dec, 2016
(8 years ago) |
Expired
|
|
US6703403 (Pediatric) | Method for improving pharmacokinetics |
Dec, 2016
(8 years ago) |
Expired
|
| USRE42889 | α- and β- amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Oct, 2016
(8 years ago) |
Expired
|
| USRE43802 | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Oct, 2016
(8 years ago) |
Expired
|
| US6037157 | Method for improving pharmacokinetics |
Jun, 2016
(8 years ago) |
Expired
|
| US6703403 | Method for improving pharmacokinetics |
Jun, 2016
(8 years ago) |
Expired
|
|
US5843946 (Pediatric) | α-and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Jun, 2016
(8 years ago) |
Expired
|
| US5843946 | α-and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Dec, 2015
(9 years ago) |
Expired
|
|
US6248775 (Pediatric) | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Feb, 2015
(10 years ago) |
Expired
|
| US6248775 | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Aug, 2014
(10 years ago) |
Expired
|
|
US6335460 (Pediatric) | α-and β-amino acid hydroxyethlamino sulfonamides useful as retroviral protease inhibitors |
Feb, 2013
(12 years ago) |
Expired
|
| US6335460 | α-and β-amino acid hydroxyethlamino sulfonamides useful as retroviral protease inhibitors |
Aug, 2012
(12 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 Prezista's patents.
Latest Legal Activities on Prezista's Patents
Given below is the list of recent legal activities going on the following patents of Prezista.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 21 Mar, 2022 | US9889115 |
| Expire Patent Critical | 10 Jan, 2022 | US8597876 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Oct, 2021 | US7700645 |
| Maintenance Fee Reminder Mailed Critical | 04 Oct, 2021 | US9889115 |
| Maintenance Fee Reminder Mailed Critical | 26 Jul, 2021 | US8597876 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Feb, 2021 | US8518987 |
| Expire Patent Critical | 01 Feb, 2021 | US7470506 |
| Maintenance Fee Reminder Mailed Critical | 17 Aug, 2020 | US7470506 |
| Patent Issue Date Used in PTA Calculation Critical | 13 Feb, 2018 | US9889115 |
| Recordation of Patent Grant Mailed Critical | 13 Feb, 2018 | US9889115 |
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 Prezista and ongoing litigations to help you estimate the early arrival of Prezista generic.
Prezista's Litigations
Prezista been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 09, 2015, against patent number US8518987. The petitioner Lupin Limited, challenged the validity of this patent, with Janssen Sciences Ireland UC as the respondent. Click below to track the latest information on how companies are challenging Prezista's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8518987 | April, 2015 |
Terminated-Denied
(16 Oct, 2015) | Janssen Sciences Ireland UC | Lupin Limited |
FDA has granted some exclusivities to Prezista. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Prezista, 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 Prezista.
Exclusivity Information
Prezista holds 9 exclusivities. All of its exclusivities have expired in 2016. Details of Prezista's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-118) | Oct 21, 2011 |
| New Indication(I-578) | Oct 21, 2011 |
| New Dosing Schedule(D-119) | Dec 18, 2011 |
| New Strength(NS) | Dec 18, 2011 |
| New Dosing Schedule(D-129) | Dec 13, 2013 |
| Pediatric Exclusivity(PED) | Aug 01, 2016 |
| New Dosage Form(NDF) | Dec 16, 2014 |
| New Patient Population(NPP) | Dec 16, 2014 |
| New Dosing Schedule(D-135) | Feb 01, 2016 |
Several oppositions have been filed on Prezista'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 Prezista's generic, the next section provides detailed information on ongoing and past EP oppositions related to Prezista patents.
Prezista's Oppositions Filed in EPO
Prezista has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 06, 2015, by Alfred E. Tiefenbacher (Gmbh & Co. Kg). This opposition was filed on patent number EP10180831A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP14168686A | Apr, 2018 | Cooke, Richard | Opposition rejected |
| EP03753571A | Mar, 2015 | Wittkopp, Alexander | Patent maintained as amended |
| EP10180831A | Mar, 2015 | Wittkopp, Alexander | Patent maintained as amended |
| EP03753571A | Mar, 2015 | Strawman Limited | Patent maintained as amended |
| EP10180831A | Mar, 2015 | Strawman Limited | Patent maintained as amended |
| EP03753571A | Mar, 2015 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Patent maintained as amended |
| EP10180831A | Mar, 2015 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Prezista 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 Prezista's family patents as well as insights into ongoing legal events on those patents.
Prezista's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Prezista's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 26, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Prezista Generic API suppliers:
Darunavir is the generic name for the brand Prezista. 10 different companies have already filed for the generic of Prezista, with Zydus Lifesciences having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Prezista's generic
How can I launch a generic of Prezista before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prezista's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prezista'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 Prezista -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 75 mg, 150 mg and 300 mg | 23 Jun, 2010 | 1 | 26 Dec, 2026 | ||
| 400 mg | 23 Jun, 2010 | 3 | 26 Dec, 2026 | ||
| 600 mg | 23 Jun, 2010 | 4 | 21 Nov, 2017 | 26 Dec, 2026 | Deferred |
| 800 mg | 14 May, 2013 | 1 | 29 Sep, 2022 | 26 Dec, 2026 | Eligible |
Alternative Brands for Prezista
Prezista which is used for treating HIV infection in both adult and pediatric patients., has several other brand drugs using the same active ingredient (Darunavir). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Darunavir, Prezista's active ingredient. Check the complete list of approved generic manufacturers for Prezista
About Prezista
Prezista is a drug owned by Janssen Products Lp. It is used for treating HIV infection in both adult and pediatric patients. Prezista uses Darunavir as an active ingredient. Prezista was launched by Janssen Prods in 2008.
Approval Date:
Prezista was approved by FDA for market use on 18 December, 2008.
Active Ingredient:
Prezista uses Darunavir as the active ingredient. Check out other Drugs and Companies using Darunavir ingredient
Treatment:
Prezista is used for treating HIV infection in both adult and pediatric patients.
Dosage:
Prezista is available in the following dosage forms - suspension form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 600MG | TABLET | Prescription | ORAL |
| 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 150MG | TABLET | Prescription | ORAL |
| 100MG/ML | SUSPENSION | Prescription | ORAL |
| 800MG | TABLET | Prescription | ORAL |
| 75MG | TABLET | Prescription | ORAL |