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Orange Book drug · Brand (NDA)

Lonsurf

Tipiracil Hydrochloride; Trifluridine

RLDNDA 207981 2 strengths Taiho Oncology
Approved
Sep 22, 2015
Strengths
2
Listed patents
6

What does the FDA Orange Book show for Lonsurf?

Lonsurf contains Tipiracil Hydrochloride; Trifluridine and is the new drug FDA Orange Book record for NDA 207981. 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 207981

New drug application identity from the Orange Book snapshot.

Application holder
Taiho Oncology 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
AB

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

Listed patents
6

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
001EQ 6.14MG BASE;15MGTABLETORALPrescriptionAB
RLD
002EQ 8.19MG BASE;20MGTABLETORALPrescriptionAB
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

Taiho Oncology Inc

The Orange Book identifies this organization as the applicant responsible for NDA 207981.

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

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

Patent & exclusivity record

6 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Feb 03, 2037. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

2 other ANDAs and 0 other NDAs found

2 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 207981 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-207981

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 207981
TE ABRLD
Strength
EQ 6.14MG BASE;15MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    11 yr ago

  2. Exclusivity ends · ODE-229

    Orphan-drug exclusivity (7 years)

    5 mo ago

  3. Today

  4. Patent RE46284 expires

    Listed method-of-use patent (U-2503) expiration.

    in 3 yr 2 mo

  5. Patent RE46284 expires

    Listed method-of-use patent (U-1751) expiration.

    in 3 yr 2 mo

  6. Patent RE46284 expires

    Listed method-of-use patent (U-3656) expiration.

    in 3 yr 2 mo

  7. Patent 10457666 expires

    Listed drug substance patent expiration.

    in 8 yr

  8. Patent 9527833 expires

    Listed drug substance patent expiration.

    in 8 yr

  9. Patent 9943537 expires

    Listed method-of-use patent (U-3659) expiration.

    in 8 yr 3 mo

  10. Patent 10456399 expires

    Listed method-of-use patent (U-3657) expiration.

    in 10 yr 8 mo

  11. Patent 10456399 expires

    Listed method-of-use patent (U-3658) expiration.

    in 10 yr 8 mo

  12. Patent 10960004 expires

    Listed method-of-use patent (U-3657) expiration.

    in 10 yr 8 mo

  13. Patent 10960004 expires

    Listed method-of-use patent (U-3658) expiration.

    in 10 yr 8 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayExclusivity ODE-229: 2026-02-22Exclusivity ODE-229Patent RE46284: 2029-09-22Patent RE46284Patent RE46284: 2029-09-22Patent RE46284Patent RE46284: 2029-09-22Patent RE46284Patent 10457666: 2034-06-17Patent 10457666Patent 9527833: 2034-06-17Patent 9527833Patent 9943537: 2034-09-05Patent 9943537Patent 10456399: 2037-02-03Patent 10456399Patent 10456399: 2037-02-03Patent 10456399Patent 10960004: 2037-02-03Patent 10960004Patent 10960004: 2037-02-03Patent 10960004
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Strength

EQ 6.14MG BASE;15MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 207981

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • ODE-229Orphan-drug exclusivity (7 years)

    5 mo ago

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
RE46284in 3 yr 2 mo
U-2503
RE46284in 3 yr 2 mo
U-1751
RE46284in 3 yr 2 mo
U-3656
10457666in 8 yr
SubstanceProduct
9527833in 8 yr
SubstanceProduct
9943537in 8 yr 3 mo
U-3659
10456399in 10 yr 8 mo
U-3657
10456399in 10 yr 8 mo
U-3658
10960004in 10 yr 8 mo
U-3657
10960004in 10 yr 8 mo
U-3658

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 Tipiracil Hydrochloride; Trifluridine 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.

Lonsurf: 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 207981 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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