Biktarvy (Gilead) is expected to face US generic competition from 2036. Settlements bar US generics before 1 April 2036, later than the earlier 2033 estimate.
Biktarvy's US exclusivity date is based on settlement / court date. Litigation settlements or a court ruling fix the earliest US entry date, which makes it one of the firmer dates in this tracker. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.
Biktarvy was selected for the Medicare Drug Price Negotiation Program. CMS is negotiating its Medicare price now; the price takes effect in 2028 and is due to be published by 30 November 2026. That is 8 years before US generics can launch, so Medicare revenue comes under pressure first. For the 25 drugs negotiated so far, Medicare prices came in 38% to 85% below list price. Those discounts are measured before the rebates drugmakers already pay and apply to Medicare only.
Settlements with Lupin, Cipla and Laurus Labs bar generics before 1 April 2036, more than two years after Gilead's previous December 2033 estimate. Fierce Pharma
Biktarvy is 49% of Gilead's 2025 revenue ($14.3B of $29.4B).
Bars show each company's tracked drugs as a share of its total 2025 revenue. Biktarvy is highlighted.