Prezcobix is a drug owned by Janssen Products Lp. It is protected by 19 US drug patents filed from 2015 to 2018. Out of these, 4 drug patents are active and 15 have expired. Prezcobix's patents have been open to challenges since 27 August, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 06, 2032. Details of Prezcobix'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. | |||
| US8148374 | Modulators of pharmacokinetic properties of therapeutics |
Sep, 2029
(4 years from now) | Active |
| US7700645 | Pseudopolymorphic forms of a HIV protease inhibitor |
Dec, 2026
(2 years from now) | Active |
| US8518987 | Pseudopolymorphic forms of a HIV protease inhibitor |
Feb, 2024
(8 months ago) |
Expired
|
| USRE43596 | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
May, 2017
(7 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10039718 | Use of solid carrier particles to improve the processability of a pharmaceutical agent |
Oct, 2032
(7 years from now) | Active |
|
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
(2 months ago) |
Expired
|
|
US8597876 (Pediatric) | Method of treating HIV infection |
Dec, 2019
(4 years ago) |
Expired
|
|
US7470506 (Pediatric) | Fitness assay and associated methods |
Dec, 2019
(4 years ago) |
Expired
|
| US7470506 | Fitness assay and associated methods |
Jun, 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
|
|
USRE43596 (Pediatric) | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Nov, 2017
(7 years ago) |
Expired
|
|
USRE42889 (Pediatric) | α- and β- amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Apr, 2017
(7 years ago) |
Expired
|
|
USRE43802 (Pediatric) | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Apr, 2017
(7 years ago) |
Expired
|
| USRE43802 | α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Oct, 2016
(8 years ago) |
Expired
|
| USRE42889 | α- and β- amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors |
Oct, 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
(8 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 Prezcobix's patents.
Latest Legal Activities on Prezcobix's Patents
Given below is the list of recent legal activities going on the following patents of Prezcobix.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2023 | US8148374 (Litigated) |
| Expire Patent Critical | 21 Mar, 2022 | US9889115 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Jan, 2022 | US10039718 |
| 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 |
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 Prezcobix and ongoing litigations to help you estimate the early arrival of Prezcobix generic.
Prezcobix's Litigations
Prezcobix 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 Prezcobix'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 Prezcobix. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Prezcobix, 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 Prezcobix.
Exclusivity Information
Prezcobix holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Prezcobix's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 27, 2017 |
Several oppositions have been filed on Prezcobix'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 Prezcobix's generic, the next section provides detailed information on ongoing and past EP oppositions related to Prezcobix patents.
Prezcobix's Oppositions Filed in EPO
Prezcobix 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 |
|---|---|---|---|
| | |||
| EP16180589A | Oct, 2020 | Cooke, Richard | Granted and Under Opposition |
| EP16180589A | Oct, 2020 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP16180589A | Jan, 2020 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP14168686A | Apr, 2018 | Cooke, Richard | Opposition rejected |
| EP12167591A | May, 2017 | Cooke, Richard | Revoked |
| EP12167590A | May, 2017 | Cooke, Richard | Revoked |
| EP12167590A | May, 2017 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP12167591A | May, 2017 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP12167589A | May, 2017 | Cooke, Richard | Granted and Under Opposition |
| EP12167589A | May, 2017 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP12167596A | Apr, 2017 | Cooke, Richard | Revoked |
| EP12167596A | Apr, 2017 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP09739981A | Jun, 2016 | Cooke, Richard | Revoked |
| EP09739981A | Jun, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP10703766A | Apr, 2016 | Cooke, Richard | Revoked |
| EP10703766A | Apr, 2016 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP07836007A | Mar, 2016 | Trösch, Dominique | Granted and Under Opposition |
| EP07836007A | Mar, 2016 | Georg Kalhammer/Stephan Teipel | Granted and Under Opposition |
| EP07836007A | Mar, 2016 | Teva Pharmaceutical Industries LTD. | Granted and Under Opposition |
| EP03753571A | Mar, 2015 | Wittkopp, Alexander | Patent maintained as amended |
| EP10180831A | Mar, 2015 | Wittkopp, Alexander | Patent maintained as amended |
| EP10180831A | Mar, 2015 | Strawman Limited | Patent maintained as amended |
| EP03753571A | 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 Prezcobix 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 Prezcobix's family patents as well as insights into ongoing legal events on those patents.
Prezcobix's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Prezcobix's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 06, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Prezcobix Generics:
There are no approved generic versions for Prezcobix as of now.
How can I launch a generic of Prezcobix before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prezcobix's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prezcobix'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 Prezcobix -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 800 mg/150 mg | 24 Jul, 2020 | 1 | 06 Oct, 2032 |
Alternative Brands for Prezcobix
Prezcobix which is used for managing HIV-1 infection in adults and pediatric patients., has several other brand drugs using the same active ingredient (Cobicistat; 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.
| Drug Owner | Drug Name | |
|---|---|---|
| Janssen Prods |
|
About Prezcobix
Prezcobix is a drug owned by Janssen Products Lp. It is used for managing HIV-1 infection in adults and pediatric patients. Prezcobix uses Cobicistat; Darunavir as an active ingredient. Prezcobix was launched by Janssen Prods in 2015.
Approval Date:
Prezcobix was approved by FDA for market use on 29 January, 2015.
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 Prezcobix is 29 January, 2015, its NCE-1 date is estimated to be 27 August, 2016.
Active Ingredient:
Prezcobix uses Cobicistat; Darunavir as the active ingredient. Check out other Drugs and Companies using Cobicistat; Darunavir ingredient
Treatment:
Prezcobix is used for managing HIV-1 infection in adults and pediatric patients.
Dosage:
Prezcobix is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG;800MG | TABLET | Prescription | ORAL |