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FDA Orange Book · active-ingredient family

Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate

Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:BIKTARVY · NDA 210251

1

Brand (NDA)

0

Generics (ANDA)

11

Listed patents

9

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
BIKTARVYRLD×2GILEAD SCIENCES INCNDA 210251—Oct 07, 2021

Marketing exclusivity (9)

  • I-942New indication exclusivity (3 years)

    Feb 23, 2027

    in 8 mo

  • ODE-378Orphan-drug exclusivity (7 years)

    Oct 07, 2028

    in 2 yr 4 mo

  • ODE-468Orphan-drug exclusivity (7 years)

    Feb 23, 2031

    in 4 yr 9 mo

  • ODE-540Orphan-drug exclusivity (7 years)

    Jul 30, 2032

    in 6 yr 2 mo

  • I-942New indication exclusivity (3 years)

    Feb 23, 2027

    in 8 mo

  • M-305New use / labeling-change exclusivity (3 years)

    Apr 24, 2027

    in 10 mo

  • ODE-256Orphan-drug exclusivity (7 years)

    Jun 18, 2026

    1 d ago

  • ODE-468Orphan-drug exclusivity (7 years)

    Feb 23, 2031

    in 4 yr 9 mo

  • ODE-540Orphan-drug exclusivity (7 years)

    Jul 30, 2032

    in 6 yr 2 mo

Listed patents (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9296769Aug 15, 2032in 6 yr 3 mo
SubstanceProductU-257
8754065Aug 15, 2032in 6 yr 3 mo
SubstanceProductU-257
9296769*PEDFeb 15, 2033in 6 yr 9 mo
8754065*PEDFeb 15, 2033in 6 yr 9 mo
9216996Dec 19, 2033in 7 yr 7 mo
SubstanceProduct
9732092Dec 19, 2033in 7 yr 7 mo
SubstanceProduct
10385067Jun 19, 2035in 9 yr 2 mo
U-257
9708342Jun 19, 2035in 9 yr 2 mo
SubstanceProduct
12594244Nov 08, 2036in 10 yr 7 mo
ProductU-257
11744802Nov 08, 2036in 10 yr 7 mo
Product
10548846Nov 08, 2036in 10 yr 7 mo
Product

Bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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