FDA Orange Book · active-ingredient family
Bictegravir sodium; lenacapavir sodium
Bictegravir sodium; lenacapavir sodium: 1 brand, 0 generics; first approved Aug 27, 2026.
Brand only
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
1
Brand (NDA) products
Originator applications
- GILEAD SCIENCES INCNDA 2211042026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE;EQ 50MG BASE TABLET ORAL Rx —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
26 d ago
Most recent approval
26 d ago
All 1 application were approved in 2026.
Brand (NDA) 1100%
Generic (ANDA) 00%
Bictegravir sodium; lenacapavir sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
