Evotaz is a drug owned by Bristol Myers Squibb Co. It is protected by 6 US drug patents filed from 2015 to 2018. Out of these, 2 drug patents are active and 4 have expired. Evotaz'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 Evotaz'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 |
| US6087383 | Bisulfate salt of HIV protease inhibitor |
Dec, 2018
(5 years ago) |
Expired
|
| US5849911 | Antivirally active heterocyclic azahexane derivatives |
Jun, 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 |
|
US6087383 (Pediatric) | Bisulfate salt of HIV protease inhibitor |
Jun, 2019
(5 years ago) |
Expired
|
|
US5849911 (Pediatric) | Antivirally active heterocyclic azahexane derivatives |
Dec, 2017
(7 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 Evotaz's patents.
Latest Legal Activities on Evotaz's Patents
Given below is the list of recent legal activities going on the following patents of Evotaz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Sep, 2023 | US8148374 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Jan, 2022 | US10039718 |
| Post Issue Communication - Certificate of Correction | 19 Jun, 2020 | US10039718 |
| Email Notification Critical | 11 Jun, 2020 | US10039718 |
| Mail Pet Dec Routed to Certificate of Corrections Branch | 10 Jun, 2020 | US10039718 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 09 Jun, 2020 | US10039718 |
| Pet Dec Routed to Certificate of Corrections Branch | 08 Jun, 2020 | US10039718 |
| Adjustment of PTA Calculation by PTO | 08 Jun, 2020 | US10039718 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 08 Jun, 2020 | US10039718 |
| Petition Entered | 14 May, 2020 | US10039718 |
FDA has granted several exclusivities to Evotaz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Evotaz, 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 Evotaz.
Exclusivity Information
Evotaz holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Evotaz'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 Evotaz'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 Evotaz's generic, the next section provides detailed information on ongoing and past EP oppositions related to Evotaz patents.
Evotaz's Oppositions Filed in EPO
Evotaz has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 16, 2016, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP07836007A. 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 |
| 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 |
US patents provide insights into the exclusivity only within the United States, but Evotaz 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 Evotaz's family patents as well as insights into ongoing legal events on those patents.
Evotaz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Evotaz'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)
Evotaz Generics:
There are no approved generic versions for Evotaz as of now.
How can I launch a generic of Evotaz before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Evotaz's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Evotaz'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 Evotaz -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 300 mg/150 mg | 13 Sep, 2017 | 1 | 03 Sep, 2029 |
Alternative Brands for Evotaz
Evotaz which is used for treating HIV-1 infection by including a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase., 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.
| Drug Owner | Drug Name | Treatment Area | ||||||
|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb |
| |||||||
| Gilead Sciences Inc |
| |||||||
About Evotaz
Evotaz is a drug owned by Bristol Myers Squibb Co. It is used for treating HIV-1 infection by including a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase. Evotaz uses Atazanavir Sulfate; Cobicistat as an active ingredient. Evotaz was launched by Bristol in 2015.
Approval Date:
Evotaz 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 Evotaz is 29 January, 2015, its NCE-1 date is estimated to be 27 August, 2016.
Active Ingredient:
Evotaz uses Atazanavir Sulfate; Cobicistat as the active ingredient. Check out other Drugs and Companies using Atazanavir Sulfate; Cobicistat ingredient
Treatment:
Evotaz is used for treating HIV-1 infection by including a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase.
Dosage:
Evotaz is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 300MG BASE;150MG | TABLET | Prescription | ORAL |