BIXLENVO Drug Patent Profile
When do Bixlenvo patents expire, and when can generic versions of Bixlenvo launch?
Bixlenvo is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are eight patents protecting this drug.
The generic ingredient in BIXLENVO is bictegravir sodium, lenacapavir sodium; lenacapavir sodium . There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bictegravir sodium, lenacapavir sodium; lenacapavir sodium profile page.
DrugPatentWatch® Generic Entry Outlook for Bixlenvo
Bixlenvo will be eligible for patent challenges on December 22, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 19, 2035. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for BIXLENVO?
- What are the global sales for BIXLENVO?
- What is Average Wholesale Price for BIXLENVO?
Summary for BIXLENVO
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BIXLENVO |
| What excipients (inactive ingredients) are in BIXLENVO? | BIXLENVO excipients list |
| DailyMed Link: | BIXLENVO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BIXLENVO
Generic Entry Date for BIXLENVO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for BIXLENVO
US Patents and Regulatory Information for BIXLENVO
BIXLENVO is protected by eight US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BIXLENVO is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | BIXLENVO | bictegravir sodium; lenacapavir sodium | TABLET;ORAL | 221104-001 | Aug 27, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) | bictegravir sodium, lenacapavir sodium; lenacapavir sodium | TABLET;ORAL | 221443-001 | Aug 27, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Gilead Sciences Inc | BIXLENVO | bictegravir sodium; lenacapavir sodium | TABLET;ORAL | 221104-001 | Aug 27, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for BIXLENVO
When does loss-of-exclusivity occur for BIXLENVO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 0903
Estimated Expiration: ⤷ Start Trial
Australia
Patent: 15276860
Patent: 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] oxazepin-8-olate
Estimated Expiration: ⤷ Start Trial
Patent: 18203175
Patent: 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
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 2016029605
Estimated Expiration: ⤷ Start Trial
Patent: 2021025861
Patent: USO DE (2R, 5S, 13AR)-7,9-DIOXO-10-((2,4,6-TRIFLUOROBENZIL)CARBAMOIL)-2,3,4,5,7,9,13,13A-OCTAHIDRO-2,5-METANOPIRIDO [1 ,2 :4,5] PIRAZINO [2,1-B][1,3] OXAZEPIN-8-OLATO DE SÓDIO
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 50307
Estimated Expiration: ⤷ Start Trial
Chile
Patent: 16003249
Estimated Expiration: ⤷ Start Trial
China
Patent: 6459085
Estimated Expiration: ⤷ Start Trial
Patent: 0563747
Patent: 抗HIV化合物及其晶型 (Anti-HIV compound and crystal form)
Estimated Expiration: ⤷ Start Trial
Costa Rica
Patent: 160589
Estimated Expiration: ⤷ Start Trial
Croatia
Patent: 0180455
Estimated Expiration: ⤷ Start Trial
Cuba
Patent: 478
Estimated Expiration: ⤷ Start Trial
Patent: 160187
Estimated Expiration: ⤷ Start Trial
Cyprus
Patent: 20025
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 57932
Estimated Expiration: ⤷ Start Trial
Dominican Republic
Patent: 016000327
Estimated Expiration: ⤷ Start Trial
Ecuador
Patent: 16095566
Estimated Expiration: ⤷ Start Trial
El Salvador
Patent: 16005339
Estimated Expiration: ⤷ Start Trial
Eurasian Patent Organization
Patent: 0967
Estimated Expiration: ⤷ Start Trial
Patent: 1692414
Estimated Expiration: ⤷ Start Trial
Patent: 1891464
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 57932
Estimated Expiration: ⤷ Start Trial
Patent: 21270
Patent: SODIUM (2R, 5S, 13AR)-7,9-DIOXO-10-((2,4,6-TRIFLUOROBENZYL) CARBAMOYL)-2, 3, 4, 5, 7, 9, 13, 13A-OCTAHYDRO-2,5-MÉTHANOPYRIDO [1', 2' : 4.5] PYRAZINO[2,1-B] OXAZEPIN-8-OLATE (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] OXAZEPIN-8-OLATE)
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 36928
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 9161
Patent: סודיום (2r,5s,13ar)-7,9-דיאוקסו-10-((2,4,6-טריפלואורובנזיל)קרבמויל)-2,3,4,5,7,9,1313a,-אוקטהידרו-2,5-מתאנופירידו[1',2':4.5]פירזינו[2,1-b]אוקסזפינ-8-אולאט (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] oxazepin-8-olate)
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 34007
Estimated Expiration: ⤷ Start Trial
Patent: 17518356
Patent: ナトリウム（２Ｒ，５Ｓ，１３ＡＲ）−７，９−ジオキソ−１０−（（２，４，６−トリフルオロベンジル）カルバモイル）−２，３，４，５，７，９，１３，１３Ａ−オクタヒドロ−２，５−メタノピリド［１’，２’：４，５］ピラジノ［２，１−Ｂ］［１，３］オキサゼピン−８−オレート
Estimated Expiration: ⤷ Start Trial
Patent: 18162246
Patent: ナトリウム（２Ｒ，５Ｓ，１３ＡＲ）−７，９−ジオキソ−１０−（（２，４，６−トリフルオロベンジル）カルバモイル）−２，３，４，５，７，９，１３，１３Ａ−オクタヒドロ−２，５−メタノピリド［１’，２’：４，５］ピラジノ［２，１−Ｂ］［１，３］オキサゼピン−８−オレート (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-OLEATE)
Estimated Expiration: ⤷ Start Trial
Patent: 20097593
Patent: ナトリウム（２Ｒ，５Ｓ，１３ＡＲ）−７，９−ジオキソ−１０−（（２，４，６−トリフルオロベンジル）カルバモイル）−２，３，４，５，７，９，１３，１３Ａ−オクタヒドロ−２，５−メタノピリド［１’，２’：４，５］ピラジノ［２，１−Ｂ］［１，３］オキサゼピン−８−オレート (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)
Estimated Expiration: ⤷ Start Trial
Patent: 22095640
Patent: ナトリウム（２Ｒ，５Ｓ，１３ＡＲ）－７，９－ジオキソ－１０－（（２，４，６－トリフルオロベンジル）カルバモイル）－２，３，４，５，７，９，１３，１３Ａ－オクタヒドロ－２，５－メタノピリド［１’，２’：４，５］ピラジノ［２，１－Ｂ］［１，３］オキサゼピン－８－オレート
Estimated Expiration: ⤷ Start Trial
Lithuania
Patent: 57932
Estimated Expiration: ⤷ Start Trial
Malaysia
Patent: 6696
Patent: 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]OXAZEPIN-8-OLATE
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 9555
Estimated Expiration: ⤷ Start Trial
Patent: 16016059
Estimated Expiration: ⤷ Start Trial
Patent: 19013380
Estimated Expiration: ⤷ Start Trial
Moldova, Republic of
Patent: 84
Estimated Expiration: ⤷ Start Trial
Patent: 170006
Estimated Expiration: ⤷ Start Trial
Patent: 180037
Estimated Expiration: ⤷ Start Trial
Montenegro
Patent: 037
Patent: NATRIJUM (2R, 5S, 13AR) -7, 9-DIOKSO-10- ( (2,4,6-TRIFLUOROBENZIL) KARBAMOIL) -2, 3, 4, 5, 7, 9, 13, 13A-OKTAHIDRO-2, 5-METANOPIRIDO [1',2' : 4,5]PIRAZINO [2, 1-B]OKSAZEPIN-8-OLATE (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]OXAZEPIN-8-OLATE)
Estimated Expiration: ⤷ Start Trial
Morocco
Patent: 239
Estimated Expiration: ⤷ Start Trial
Patent: 221
Patent: SODIUM (2R, 5S, 13AR)-7,9-DIOXO-10-((2,4,6-TRIFLUOROBENZYL) CARBAMOYL)-2, 3, 4, 5, 7, 9, 13, 13A-OCTAHYDRO-2,5-MÉTHANOPYRIDO [1', 2' : 4.5] PYRAZINO[2,1-B] OXAZEPIN-8-OLATE
Estimated Expiration: ⤷ Start Trial
New Zealand
Patent: 7155
Patent: 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
Estimated Expiration: ⤷ Start Trial
Norway
Patent: 17902
Estimated Expiration: ⤷ Start Trial
Peru
Patent: 170150
Estimated Expiration: ⤷ Start Trial
Philippines
Patent: 016502499
Patent: 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
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 57932
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 57932
Estimated Expiration: ⤷ Start Trial
Serbia
Patent: 950
Patent: NATRIJUM (2R, 5S, 13AR) -7, 9-DIOKSO-10- ( (2,4,6-TRIFLUOROBENZIL) KARBAMOIL) -2, 3, 4, 5, 7, 9, 13, 13A-OKTAHIDRO-2, 5-METANOPIRIDO [1’,2’ : 4.5]PIRAZINO [2,1-B]OKSAZEPIN-8-OLAT (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]OXAZEPIN-8-OLATE)
Estimated Expiration: ⤷ Start Trial
Singapore
Patent: 201610211Q
Patent: 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] OXAZEPIN-8-OLATE
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 57932
Estimated Expiration: ⤷ Start Trial
South Africa
Patent: 1608744
Patent: 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] OXAZEPIN-8-OLATE
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 1899803
Estimated Expiration: ⤷ Start Trial
Patent: 170016985
Patent: 소듐 (2R,5S,13AR)-7,9-디옥소-10--2,3,4,5,7,9,13,13A-옥타히드로-2,5-메타노피리도[1'',2'':4,5]피라지노[2,1-B][1,3]옥사제핀-8-올레이트 (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] OXAZEPIN-8-OLATE)
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 60862
Estimated Expiration: ⤷ Start Trial
Taiwan
Patent: 1613937
Patent: Sodium(2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoly)-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
Estimated Expiration: ⤷ Start Trial
Patent: 2014422
Patent: Sodium (2R, 5S, 13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoly)-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
Estimated Expiration: ⤷ Start Trial
Patent: 73274
Estimated Expiration: ⤷ Start Trial
Patent: 31354
Estimated Expiration: ⤷ Start Trial
Turkey
Patent: 1802179
Estimated Expiration: ⤷ Start Trial
Ukraine
Patent: 8480
Estimated Expiration: ⤷ Start Trial
Uruguay
Patent: 177
Estimated Expiration: ⤷ Start Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering BIXLENVO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 109364 | ⤷ Start Trial | |
| Argentina | 115865 | ⤷ Start Trial | |
| Argentina | 117709 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BIXLENVO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2822954 | 300947 | Netherlands | ⤷ Start Trial | PRODUCT NAME: BICTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BICTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
| 2822954 | 122018000094 | Germany | ⤷ Start Trial | PRODUCT NAME: BICTEGRAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BICTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180621 |
| 2822954 | LUC00083 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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