Bixlenvo is a drug owned by Gilead Sciences Inc. It is protected by 8 US drug patents filed in 2026 out of which none have expired yet. Bixlenvo's patents will be open to challenges from 22 December, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 16, 2038. Details of Bixlenvo'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. | |||
| US11267799 | Solid forms of an HIV capsid inhibitor |
Aug, 2038
(11 years from now) | Active |
| US10071985 | Therapeutic compounds |
Aug, 2037
(10 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
(8 years from now) | Active |
| US9951043 | Therapeutic compounds |
Feb, 2034
(7 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
(7 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
(7 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10654827 | Therapeutic compounds |
Aug, 2037
(10 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
(8 years from now) | Active |
FDA has granted several exclusivities to Bixlenvo. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Bixlenvo, 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
Bixlenvo.
Exclusivity Information
Bixlenvo holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Bixlenvo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 22, 2027 |
| New Product(NP) | Aug 27, 2029 |
Several oppositions have been filed on Bixlenvo'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 Bixlenvo's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Bixlenvo patents.
Bixlenvo's Oppositions Filed in EPO
Bixlenvo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 10, 2018, by Cooke, Richard. This opposition was filed on patent number EP15739063A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15739063A | Oct, 2018 | Cooke, Richard | Revoked |
US patents provide insights into the exclusivity only within the United States, but
Bixlenvo 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 Bixlenvo's family patents as well as insights into
ongoing legal events
on those patents.
Bixlenvo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bixlenvo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 16, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bixlenvo Generics:
There are no approved generic versions for Bixlenvo as of now.
Alternative Brands for Bixlenvo
There are several other brand drugs in the same treatment category as Bixlenvo. 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 | ||
|---|---|---|---|---|
| Gilead Sciences Inc |
| |||
About Bixlenvo
Bixlenvo is a drug owned by Gilead Sciences Inc. Bixlenvo uses Bictegravir Sodium; Lenacapavir Sodium as an active ingredient. Bixlenvo was launched by Gilead in 2026.
Approval Date:
Bixlenvo was approved by FDA for market use on 27 August, 2026.
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 Bixlenvo is 27 August, 2026, its NCE-1 date is estimated to be 22 December, 2026.
Active Ingredient:
Bixlenvo uses Bictegravir Sodium; Lenacapavir Sodium as the active ingredient. Check out other Drugs and Companies using Bictegravir Sodium; Lenacapavir Sodium ingredient
Dosage:
Bixlenvo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 75MG BASE;EQ 50MG BASE | TABLET | Prescription | ORAL |