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Orange Book drug · Brand (NDA)

Xtandi

Enzalutamide

RLDNDA 203415 Astellas
Approved
Aug 31, 2012
Strengths
1
Listed patents
4
Applications
2

What does the FDA Orange Book show for Xtandi?

Xtandi contains Enzalutamide and appears in 2 FDA Orange Book applications. NDA 203415 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
2; lead NDA 203415

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Astellas Pharma US Inc

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

Product presentations
1

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
4

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

Exclusivity records
1

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
00140MGCAPSULEORALPrescriptionNone posted
RLDRS

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

Astellas Pharma US Inc

The Orange Book identifies this organization as the applicant responsible for NDA 203415.

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

1 presentation 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

3 listed patent expirations and 1 exclusivity date remain on or after Jul 26, 2026

The latest future date recorded across those files is Feb 23, 2037. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

4 other ANDAs and 0 other NDAs found

1 of the related ANDA application is 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 203415 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-203415

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.

Product detail

NDA 203415
RLDRS
Strength
40MG
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    14 yr 1 mo ago

  2. Patent 9126941 expires

    Listed method-of-use patent (U-2345) expiration.

    2 mo ago

  3. Patent 9126941 expires

    Listed method-of-use patent (U-1588) expiration.

    2 mo ago

  4. Patent 9126941 expires

    Listed method-of-use patent (U-2708) expiration.

    2 mo ago

  5. Patent 9126941 expires

    Listed method-of-use patent (U-3763) expiration.

    2 mo ago

  6. Today

  7. Patent 8183274 expires

    Listed method-of-use patent (U-1281) expiration.

    in 29 d

  8. Patent 8183274 expires

    Listed method-of-use patent (U-1588) expiration.

    in 29 d

  9. Patent 8183274 expires

    Listed method-of-use patent (U-2708) expiration.

    in 29 d

  10. Patent 8183274 expires

    Listed method-of-use patent (U-2345) expiration.

    in 29 d

  11. Patent 8183274 expires

    Listed method-of-use patent (U-3763) expiration.

    in 29 d

  12. Exclusivity ends · I-926

    New indication exclusivity (3 years)

    in 4 mo

  13. Patent 7709517 expires

    Listed drug substance patent expiration.

    in 1 yr 1 mo

  14. Patent 12161628 expires

    Listed method-of-use patent (U-4101) expiration.

    in 10 yr 9 mo

  15. Patent 12161628 expires

    Listed method-of-use patent (U-4102) expiration.

    in 10 yr 9 mo

  16. Patent 12161628 expires

    Listed method-of-use patent (U-4103) expiration.

    in 10 yr 9 mo

  17. Patent 12161628 expires

    Listed method-of-use patent (U-4104) expiration.

    in 10 yr 9 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayPatent 9126941: 2026-05-15Patent 9126941Patent 9126941: 2026-05-15Patent 9126941Patent 9126941: 2026-05-15Patent 9126941Patent 9126941: 2026-05-15Patent 9126941Patent 8183274: 2026-08-24Patent 8183274Patent 8183274: 2026-08-24Patent 8183274Patent 8183274: 2026-08-24Patent 8183274Patent 8183274: 2026-08-24Patent 8183274Patent 8183274: 2026-08-24Patent 8183274Exclusivity I-926: 2026-11-17Exclusivity I-926Patent 7709517: 2027-08-13Patent 7709517Patent 12161628: 2037-02-23Patent 12161628Patent 12161628: 2037-02-23Patent 12161628Patent 12161628: 2037-02-23Patent 12161628Patent 12161628: 2037-02-23Patent 12161628
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

ENZALUTAMIDE

Strength

40MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 203415

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • I-926New indication exclusivity (3 years)

    in 4 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
91269412 mo ago
U-2345
91269412 mo ago
U-1588
91269412 mo ago
U-2708
91269412 mo ago
U-3763
8183274in 29 d
U-1281
8183274in 29 d
U-1588
8183274in 29 d
U-2708
8183274in 29 d
U-2345
8183274in 29 d
U-3763
7709517in 1 yr 1 mo
SubstanceProduct
12161628in 10 yr 9 mo
U-4101
12161628in 10 yr 9 mo
U-4102
12161628in 10 yr 9 mo
U-4103
12161628in 10 yr 9 mo
U-4104

Other FDA applications for Xtandi

1 additional filing

The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Xtandi, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 213674AstellasAug 04, 20202ABPrescription

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.

View full Enzalutamide 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.

Xtandi: 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 203415 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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