Biktarvy Patent Expiration

Biktarvy is a drug owned by Gilead Sciences Inc. It is protected by 15 US drug patents filed from 2018 to 2023. Out of these, 12 drug patents are active and 3 have expired. Biktarvy's patents have been open to challenges since 07 February, 2022. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
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
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
US8754065 Tenofovir alafenamide hemifumarate
Aug, 2032

(7 years from now)

Active
US9296769 Tenofovir alafenamide hemifumarate
Aug, 2032

(7 years from now)

Active
US7390791 Prodrugs of phosphonate nucleotide analogues
Apr, 2025

(5 months from now)

Active
US6703396 Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Mar, 2021

(3 years ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
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
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
US9296769

(Pediatric)

Tenofovir alafenamide hemifumarate
Feb, 2033

(8 years from now)

Active
US8754065

(Pediatric)

Tenofovir alafenamide hemifumarate
Feb, 2033

(8 years from now)

Active
US7390791

(Pediatric)

Prodrugs of phosphonate nucleotide analogues
Oct, 2025

(11 months from now)

Active
US7803788 Prodrugs of phosphonate nucoleotide analogues
Feb, 2022

(2 years ago)

Expired
US6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Nov, 2020

(3 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 Biktarvy's patents.

Given below is the list of recent legal activities going on the following patents of Biktarvy.

Activity Date Patent Number
Patent litigations
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


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 Biktarvy and ongoing litigations to help you estimate the early arrival of Biktarvy generic.

Biktarvy's Litigations

Biktarvy been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 05, 2001, against patent number US6642245. The petitioner , challenged the validity of this patent, with DIONNE as the respondent. Click below to track the latest information on how companies are challenging Biktarvy's patents.

Last updated on October 22, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6703396 April, 2002 Decision
(04 Apr, 2002)
DIONNE
US6642245 July, 2001 Decision
(05 Jul, 2001)
DIONNE


FDA has granted some 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

Alternative Brands for Biktarvy

Biktarvy which is used for treating HIV infection., 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
Abbvie
Kaletra used for treating HIV-1 infection in combination with other antiretroviral agents.
Agouron Pharms
Viracept Used for managing HIV infection.
Bristol Myers Squibb
Sustiva used for managing HIV infection in combination with other antiviral drugs.
Gilead
Emtriva Used for treating HIV infection in adults.
Truvada Used for treating HIV-1 infection in adults and pediatric patients.
Gilead Sciences
Atripla Used for managing HIV-1 infection in adults and pediatric patients aged 12 years and older.
Gilead Sciences Inc
Descovy Used for managing and treating HIV infection.
Genvoya Used for treating HIV infection with a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monoxygenase.
Odefsey Used for treating HIV infection.
Vitekta Used for managing HIV infection.
Complera Used for managing and treating HIV infection.
Stribild Used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase.
Glaxosmithkline
Agenerase Used for managing HIV infection.
Msd Sub Merck
Isentress Used for treating HIV infection by inhibiting integrase.
Isentress Hd Used for treating HIV infection.
Viiv Hlthcare
Dovato Used for the treatment of HIV infection.
Juluca Used for managing HIV infection.
Lexiva Used for managing and treating HIV infection.
Epzicom Used for treating HIV infection.





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.

Approval Date:

Biktarvy was approved by FDA for market use on 07 October, 2021.

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 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


Biktarvy News

ST Pharm secures significant API supply contract with Gilead Sciences, according to sources from the pharmaceutical industry.

22 Aug, 2024

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