Generic competition · all medicines · read 12 November 2026
Is there a generic of Bictegravir Sodium; Lenacapavir Sodium, and who makes it?
Bictegravir Sodium; Lenacapavir Sodium appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Bictegravir Sodium; Lenacapavir Sodium appears in 1 dosage-form group in the FDA Orange Book as of 12 November 2026, with no generic maker listed as marketed.
- 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Tablet, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Bixlenvo. No generic is listed as marketed.
Patents and exclusivities still listed
- 22 December 2027Exclusivity NCE Bixlenvo
- 27 August 2029Exclusivity NP Bixlenvo
- 19 December 2033Patent 9732092 drug substance
- 19 December 2033Patent 9216996 drug substance
- 28 February 2034Patent 9951043 drug substance
- 19 June 2035Patent 10385067
- 19 June 2035Patent 9708342 drug substance
- 17 August 2037Patent 10654827
- 17 August 2037Patent 10071985 drug substance
- 16 August 2038Patent 11267799 drug substance
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.