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Generic competition · all medicines · read 12 November 2026

Is there a generic of Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate, and who makes it?

Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate 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; Emtricitabine; Tenofovir Alafenamide Fumarate1 dosage-form group in the Orange Book
0generic makers listed
  1. Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate 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: Biktarvy. No generic is listed as marketed.

20152020202520302035204001brand 2018data datePatent 9296769 listed to expire 15 August 2032Patent 8754065 listed to expire 15 August 2032Patent 9296769*PED listed to expire 15 February 2033Patent 8754065*PED listed to expire 15 February 2033Patent 9216996 listed to expire 19 December 2033Patent 9732092 listed to expire 19 December 2033Patent 10385067 listed to expire 19 June 2035Patent 9708342 listed to expire 19 June 2035Patent 12594244 listed to expire 8 November 2036Patent 11744802 listed to expire 8 November 2036Patent 10548846 listed to expire 8 November 2036Exclusivity I-942 to 23 February 2027Exclusivity M-305 to 24 April 2027Exclusivity ODE-378 to 7 October 2028Exclusivity ODE-468 to 23 February 2031Exclusivity ODE-540 to 30 July 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 23 February 2027Exclusivity I-942 Biktarvy
  • 24 April 2027Exclusivity M-305 Biktarvy
  • 7 October 2028Exclusivity ODE-378 Biktarvy
  • 23 February 2031Exclusivity ODE-468 Biktarvy
  • 30 July 2032Exclusivity ODE-540 Biktarvy
  • 15 August 2032Patent 9296769 drug substance
  • 15 August 2032Patent 8754065 drug substance
  • 15 February 2033Patent 9296769*PED
  • 15 February 2033Patent 8754065*PED
  • 19 December 2033Patent 9216996 drug substance
  • 19 December 2033Patent 9732092 drug substance
  • 19 June 2035Patent 10385067
  • 19 June 2035Patent 9708342 drug substance

3 more patents are listed.

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.