Biktarvy is a drug owned by Gilead Sciences Inc. It is protected by 15 US drug patents filed from 2018 to 2024. Out of these, 12 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 08, 2036. Details of Biktarvy's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US6703396 | Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers |
Mar, 2021
(3 years ago) |
Expired
|
| US7390791 | Prodrugs of phosphonate nucleotide analogues |
Apr, 2025
(8 months from now) | Active |
| US9296769 | Tenofovir alafenamide hemifumarate |
Aug, 2032
(8 years from now) | Active |
| US8754065 | Tenofovir alafenamide hemifumarate |
Aug, 2032
(8 years from now) | Active |
| US9732092 | Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]OXAZEPINES and methods for treating viral infections |
Dec, 2033
(9 years from now) | Active |
| US9216996 | Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazepines and methods for treating viral infections |
Dec, 2033
(9 years from now) | Active |
| US9708342 | Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1′,2′:4,5]pyrazino[2, 1-b][1, 3]oxazepin-8-olate |
Jun, 2035
(10 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6642245 | Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane |
Nov, 2020
(3 years ago) |
Expired
|
| US7803788 | Prodrugs of phosphonate nucoleotide analogues |
Feb, 2022
(2 years ago) |
Expired
|
|
US7390791 (Pediatric) | Prodrugs of phosphonate nucleotide analogues |
Oct, 2025
(1 year, 2 months from now) | Active |
|
US8754065 (Pediatric) | Tenofovir alafenamide hemifumarate |
Feb, 2033
(8 years from now) | Active |
|
US9296769 (Pediatric) | Tenofovir alafenamide hemifumarate |
Feb, 2033
(8 years from now) | Active |
| US10385067 | Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate |
Jun, 2035
(10 years from now) | Active |
| US11744802 | Therapeutic compositions for treatment of human immunodeficiency virus |
Nov, 2036
(12 years from now) | Active |
| US10548846 | Therapeutic compositions for treatment of human immunodeficiency virus |
Nov, 2036
(12 years from now) | Active |
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 Biktarvy's patents.
Latest Legal Activities on Biktarvy's Patents
Given below is the list of recent legal activities going on the following patents of Biktarvy.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Sep, 2023 | US9296769 |
| Patent eGrant Notification | 05 Sep, 2023 | US11744802 |
| Recordation of Patent Grant Mailed | 05 Sep, 2023 | US11744802 |
| Patent Issue Date Used in PTA Calculation | 05 Sep, 2023 | US11744802 |
| Email Notification | 05 Sep, 2023 | US11744802 |
| Mail Patent eGrant Notification | 05 Sep, 2023 | US11744802 |
| Recordation of Patent eGrant | 05 Sep, 2023 | US11744802 |
| Email Notification | 17 Aug, 2023 | US11744802 |
| Electronic Review | 17 Aug, 2023 | US11744802 |
| Issue Notification Mailed | 16 Aug, 2023 | US11744802 |
FDA has granted several exclusivities to Biktarvy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Biktarvy, 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 Biktarvy.
Exclusivity Information
Biktarvy holds 8 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Biktarvy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Jun 18, 2022 |
| New Chemical Entity Exclusivity(NCE) | Feb 07, 2023 |
| M(M-82) | Feb 24, 2024 |
| Orphan Drug Exclusivity(ODE-256) | Jun 18, 2026 |
| New Indication(I-942) | Feb 23, 2027 |
| M(M-305) | Apr 24, 2027 |
| Orphan Drug Exclusivity(ODE-378) | Oct 07, 2028 |
| Orphan Drug Exclusivity(ODE-468) | Feb 23, 2031 |
Several oppositions have been filed on Biktarvy'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 Biktarvy's generic, the next section provides detailed information on ongoing and past EP oppositions related to Biktarvy patents.
Biktarvy's oppositions filed in EPO
Biktarvy has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 23, 2015, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP01961695A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16798063A | May, 2020 | Sandoz GmbH | Granted and Under Opposition |
| EP16798063A | May, 2020 | Cooke, Richard | Granted and Under Opposition |
| EP16798063A | May, 2020 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP15739063A | Oct, 2018 | Cooke, Richard | Revoked |
| EP13164300A | Jan, 2018 | Georg Kalhammer/Stephan Teipel | Granted and Under Opposition |
| EP13164300A | Jan, 2018 | Aechter, Bernd | Granted and Under Opposition |
| EP13164300A | Jan, 2018 | Cooke, Richard | Granted and Under Opposition |
| EP12753867A | Jul, 2017 | FRKelly | Granted and Under Opposition |
| EP12753867A | Jul, 2017 | Sandoz GmbH | Granted and Under Opposition |
| EP12753867A | Jul, 2017 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP01961695A | Nov, 2015 | HEXAL PHARMA AG | Patent maintained as amended |
| EP01961695A | Nov, 2015 | Strawman Limited | Patent maintained as amended |
| EP01961695A | Nov, 2015 | Swindell & Pearson Limited | Patent maintained as amended |
| EP01961695A | Nov, 2015 | Teva Pharmaceutical Industries Ltd | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Biktarvy 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 Biktarvy's family patents as well as insights into ongoing legal events on those patents.
Biktarvy's family patents
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Generic Launch
Generic Release Date:
Biktarvy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 08, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Biktarvy Generics:
There are no approved generic versions for Biktarvy as of now.
How can I launch a generic of Biktarvy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Biktarvy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Biktarvy'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 Biktarvy -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/200 mg/ 25 mg | 07 Feb, 2022 | 3 | 08 Nov, 2036 |
About Biktarvy
Biktarvy is a drug owned by Gilead Sciences Inc. It is used for treating HIV infection. Biktarvy uses Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate as an active ingredient. Biktarvy was launched by Gilead Sciences Inc in 2021.
Market Authorisation Date:
Biktarvy was approved by FDA for market use on 07 October, 2021.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Biktarvy is 07 October, 2021, its NCE-1 date is estimated to be 07 February, 2022
Active Ingredient:
Biktarvy uses Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate as the active ingredient. Check out other Drugs and Companies using Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate ingredient
Treatment:
Biktarvy is used for treating HIV infection.
Dosage:
Biktarvy is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE;200MG;EQ 25MG BASE | TABLET | Prescription | ORAL |
| EQ 30MG BASE;120MG;EQ 15MG BASE | TABLET | Prescription | ORAL |