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Orange Book drug · Brand (NDA)

Biktarvy

Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate

RLDNDA 210251 2 strengths Gilead Sciences Inc
Approved
Feb 07, 2018
Strengths
2
Listed patents
11

What does the FDA Orange Book show for Biktarvy?

Biktarvy contains Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate and is the new drug FDA Orange Book record for NDA 210251. The application has 2 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 210251

New drug application identity from the Orange Book snapshot.

Application holder
Gilead Sciences Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
2

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
11

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
6

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001EQ 50MG BASE;200MG;EQ 25MG BASETABLETORALPrescriptionNone posted
RLDRS
002EQ 30MG BASE;120MG;EQ 15MG BASETABLETORALPrescriptionNone posted
RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Gilead Sciences Inc

The Orange Book identifies this organization as the applicant responsible for NDA 210251.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

2 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

11 listed patent expirations and 5 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Nov 08, 2036. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 210251 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Oral

Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate

1 application
Product rows
2
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-210251

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

2 approved presentations · NDA 210251
RLDRS
Strength
EQ 50MG BASE;200MG;EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    8 yr 7 mo ago

  2. Exclusivity ends · ODE-256

    Orphan-drug exclusivity (7 years)

    1 mo ago

  3. Today

  4. Exclusivity ends · I-942

    New indication exclusivity (3 years)

    in 7 mo

  5. Exclusivity ends · M-305

    New use / labeling-change exclusivity (3 years)

    in 9 mo

  6. Exclusivity ends · ODE-468

    Orphan-drug exclusivity (7 years)

    in 4 yr 8 mo

  7. Exclusivity ends · ODE-540

    Orphan-drug exclusivity (7 years)

    in 6 yr 1 mo

  8. Patent 8754065 expires

    Listed drug substance patent expiration.

    in 6 yr 2 mo

  9. Patent 9296769 expires

    Listed drug substance patent expiration.

    in 6 yr 2 mo

  10. Patent 8754065*PED expires

    Listed listed patent expiration.

    in 6 yr 8 mo

  11. Patent 9296769*PED expires

    Listed listed patent expiration.

    in 6 yr 8 mo

  12. Patent 9216996 expires

    Listed drug substance patent expiration.

    in 7 yr 6 mo

  13. Patent 9732092 expires

    Listed drug substance patent expiration.

    in 7 yr 6 mo

  14. Patent 10385067 expires

    Listed method-of-use patent (U-257) expiration.

    in 9 yr

  15. Patent 9708342 expires

    Listed drug substance patent expiration.

    in 9 yr

  16. Patent 10548846 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  17. Patent 11744802 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

  18. Patent 12594244 expires

    Listed drug product patent expiration.

    in 10 yr 5 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036TodayExclusivity ODE-256: 2026-06-18Exclusivity ODE-256Exclusivity I-942: 2027-02-23Exclusivity I-942Exclusivity M-305: 2027-04-24Exclusivity M-305Exclusivity ODE-468: 2031-02-23Exclusivity ODE-468Exclusivity ODE-540: 2032-07-30Exclusivity ODE-540Patent 8754065: 2032-08-15Patent 8754065Patent 9296769: 2032-08-15Patent 9296769Patent 8754065*PED: 2033-02-15Patent 8754065*PEDPatent 9296769*PED: 2033-02-15Patent 9296769*PEDPatent 9216996: 2033-12-19Patent 9216996Patent 9732092: 2033-12-19Patent 9732092Patent 10385067: 2035-06-19Patent 10385067Patent 9708342: 2035-06-19Patent 9708342Patent 10548846: 2036-11-08Patent 10548846Patent 11744802: 2036-11-08Patent 11744802Patent 12594244: 2036-11-08Patent 12594244
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Strength

EQ 50MG BASE;200MG;EQ 25MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 210251

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

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

    1 mo ago

  • I-942New indication exclusivity (3 years)

    in 7 mo

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

    in 9 mo

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

    in 4 yr 8 mo

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

    in 6 yr 1 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8754065in 6 yr 2 mo
SubstanceProductU-257
9296769in 6 yr 2 mo
SubstanceProductU-257
8754065*PEDin 6 yr 8 mo
9296769*PEDin 6 yr 8 mo
9216996in 7 yr 6 mo
SubstanceProduct
9732092in 7 yr 6 mo
SubstanceProduct
10385067in 9 yr
U-257
9708342in 9 yr
SubstanceProduct
10548846in 10 yr 5 mo
Product
11744802in 10 yr 5 mo
Product
12594244in 10 yr 5 mo
ProductU-257

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Biktarvy: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 210251 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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