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Biktarvy patents expiration

BIKTARVY's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6703396 GILEAD SCIENCES INC Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Mar, 2021

(3 years ago)

US7390791 GILEAD SCIENCES INC Prodrugs of phosphonate nucleotide analogues
Apr, 2025

(11 months from now)

US9296769 GILEAD SCIENCES INC Tenofovir alafenamide hemifumarate
Aug, 2032

(8 years from now)

US8754065 GILEAD SCIENCES INC Tenofovir alafenamide hemifumarate
Aug, 2032

(8 years from now)

US9216996 GILEAD SCIENCES INC 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)

US9732092 GILEAD SCIENCES INC 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)

US9708342 GILEAD SCIENCES INC 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

(11 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6642245 GILEAD SCIENCES INC Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Nov, 2020

(3 years ago)

US7803788 GILEAD SCIENCES INC Prodrugs of phosphonate nucoleotide analogues
Feb, 2022

(2 years ago)

US7390791

(Pediatric)

GILEAD SCIENCES INC Prodrugs of phosphonate nucleotide analogues
Oct, 2025

(1 year, 5 months from now)

US8754065

(Pediatric)

GILEAD SCIENCES INC Tenofovir alafenamide hemifumarate
Feb, 2033

(8 years from now)

US9296769

(Pediatric)

GILEAD SCIENCES INC Tenofovir alafenamide hemifumarate
Feb, 2033

(8 years from now)

US10385067 GILEAD SCIENCES INC 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

(11 years from now)

US10548846 GILEAD SCIENCES INC Therapeutic compositions for treatment of human immunodeficiency virus
Nov, 2036

(12 years from now)

US11744802 GILEAD SCIENCES INC Therapeutic compositions for treatment of human immunodeficiency virus
Nov, 2036

(12 years from now)

Biktarvy is owned by Gilead Sciences Inc.

Biktarvy contains Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate.

Biktarvy has a total of 15 drug patents out of which 3 drug patents have expired.

Expired drug patents of Biktarvy are:

  • US6642245
  • US7803788
  • US6703396

Biktarvy was authorised for market use on 07 October, 2021.

Biktarvy is available in tablet;oral dosage forms.

Biktarvy can be used as treatment of hiv infection.

Drug patent challenges can be filed against Biktarvy from 07 February, 2022.

The generics of Biktarvy are possible to be released after 08 November, 2036.

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-256) Jun 18, 2026
M(M-82) Feb 24, 2024
Orphan Drug Exclusivity(ODE-468) Feb 23, 2031
Orphan Drug Exclusivity(ODE-378) Oct 07, 2028
New Chemical Entity Exclusivity(NCE) Feb 07, 2023
New Patient Population(NPP) Jun 18, 2022

Drugs and Companies using BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE ingredient

NCE-1 date: 07 February, 2022

Market Authorisation Date: 07 October, 2021

Treatment: Treatment of hiv infection

Dosage: TABLET;ORAL

How can I launch a generic of BIKTARVY before it's drug patent expiration?
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BIKTARVY family patents

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