bictegravir sodium; lenacapavir sodium - Profile
What are the generic sources for bictegravir sodium; lenacapavir sodium and what is the scope of freedom to operate?
Bictegravir sodium; lenacapavir sodium
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for bictegravir sodium; lenacapavir sodium
Generic Entry Date for bictegravir sodium; lenacapavir sodium*:
Constraining patent/regulatory exclusivity:
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.
US Patents and Regulatory Information for bictegravir sodium; lenacapavir sodium
| 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 | 10,654,827 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | BIXLENVO | bictegravir sodium; lenacapavir sodium | TABLET;ORAL | 221104-001 | Aug 27, 2026 | RX | Yes | Yes | 10,385,067 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | BIXLENVO | bictegravir sodium; lenacapavir sodium | TABLET;ORAL | 221104-001 | Aug 27, 2026 | RX | Yes | Yes | 9,951,043 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Gilead Sciences Inc | BIXLENVO | bictegravir sodium; lenacapavir sodium | TABLET;ORAL | 221104-001 | Aug 27, 2026 | RX | Yes | Yes | 9,732,092 | ⤷ Start Trial | Y | 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 bictegravir sodium; lenacapavir sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 109364 | ⤷ Start Trial | |
| Argentina | 115865 | ⤷ Start Trial | |
| Argentina | 117709 | ⤷ Start Trial | |
| Australia | 2017312102 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for bictegravir sodium; lenacapavir sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3347352 | SPC/GB22/064 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REGISTERED: UK EU/1/22/1671(FOR NI) 20220819; UK MORE ON HISTORY TAB 20220819 |
| 2822954 | 201840024 | Slovenia | ⤷ Start Trial | PRODUCT NAME: BICTEGRAVIR OR ITS PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY NATRIUM BICTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/18/1289; DATE OF NATIONAL AUTHORISATION: 20180621; AUTHORITY FOR NATIONAL AUTHORISATION: EU |
| 3347352 | 22C1063 | France | ⤷ Start Trial | PRODUCT NAME: LENACAPAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LENACAPAVIR SODIQUE; REGISTRATION NO/DATE: EU/1/22/1671 20220819 |
| 3347352 | PA2023501 | Lithuania | ⤷ Start Trial | PRODUCT NAME: LENAKAPAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC LENAKAPAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/22/1671/001-002 20220817 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
