Biktarvy Patent Expiration

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
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
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
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
US9296769

(Pediatric)

Tenofovir alafenamide hemifumarate
Feb, 2033

(8 years from now)

Active
US8754065

(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
US10548846 Therapeutic compositions for treatment of human immunodeficiency virus
Nov, 2036

(12 years from now)

Active
US11744802 Therapeutic compositions for treatment of human immunodeficiency virus
Nov, 2036

(12 years from now)

Active


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

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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
Patent litigations
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

Biktarvy has patent protection in a total of 55 countries. It's US patent count contributes only to 13.2% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Biktarvy.

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