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Generic competition · all medicines · read 12 November 2026

Is there a generic of Bictegravir Sodium, Lenacapavir Sodium; Lenacapavir Sodium, and who makes it?

Bictegravir Sodium, Lenacapavir 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.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Bictegravir Sodium, Lenacapavir Sodium; Lenacapavir Sodium1 dosage-form group in the Orange Book
0generic makers listed
  1. Bictegravir Sodium, Lenacapavir 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.
  2. 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.
  3. 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 Sunlenca Starter Pack (Copackaged). No generic is listed as marketed.

2020202520302035204001brand 2026data datePatent 9732092 listed to expire 19 December 2033Patent 9216996 listed to expire 19 December 2033Patent 9951043 listed to expire 28 February 2034Patent 10385067 listed to expire 19 June 2035Patent 9708342 listed to expire 19 June 2035Patent 10654827 listed to expire 17 August 2037Patent 10071985 listed to expire 17 August 2037Patent 11267799 listed to expire 16 August 2038Exclusivity NCE to 22 December 2027Exclusivity NP to 27 August 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 22 December 2027Exclusivity NCE Bixlenvo Sunlenca Starter Pack (Copackaged)
  • 27 August 2029Exclusivity NP Bixlenvo Sunlenca Starter Pack (Copackaged)
  • 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.