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Orange Book drug · Brand (NDA)

Xartemis XR

Acetaminophen; Oxycodone Hydrochloride

DiscontinuedRLDNDA 204031 Mallinckrodt Inc
Approved
Mar 11, 2014
Strengths
1
Listed patents
12

What does the FDA Orange Book show for Xartemis XR?

Xartemis XR contains Acetaminophen; Oxycodone Hydrochloride and is the new drug FDA Orange Book record for NDA 204031. The application has 1 presentation 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 204031

New drug application identity from the Orange Book snapshot.

Application holder
Mallinckrodt 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
Discontinued

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

Reference roles
RLD

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
12

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

Exclusivity records
0

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
001325MG;7.5MGTABLET, EXTENDED RELEASEORALDiscontinuedNone 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

Mallinckrodt Inc

The Orange Book identifies this organization as the applicant responsible for NDA 204031.

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 on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

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

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

The latest future date recorded across those files is May 16, 2032. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

64 other ANDAs and 0 other NDAs found

20 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 204031 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, Extended Release · Oral

Acetaminophen; Oxycodone Hydrochloride

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

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-204031

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 204031
RLDDiscontinued
Strength
325MG;7.5MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    12 yr 7 mo ago

  2. Today

  3. Patent 7976870 expires

    Listed method-of-use patent (U-1498) expiration.

    in 10 mo

  4. Patent 8372432 expires

    Listed drug product patent expiration.

    in 2 yr 8 mo

  5. Patent 8394408 expires

    Listed drug product patent expiration.

    in 2 yr 8 mo

  6. Patent 8668929 expires

    Listed method-of-use patent (U-1499) expiration.

    in 2 yr 8 mo

  7. Patent 8377453 expires

    Listed drug product patent expiration.

    in 3 yr 4 mo

  8. Patent 8597681 expires

    Listed drug product patent expiration.

    in 4 yr 6 mo

  9. Patent 8980319 expires

    Listed drug product patent expiration.

    in 4 yr 6 mo

  10. Patent 8658631 expires

    Listed drug product patent expiration.

    in 5 yr 11 mo

  11. Patent 8741885 expires

    Listed drug product patent expiration.

    in 5 yr 11 mo

  12. Patent 8992975 expires

    Listed drug product patent expiration.

    in 5 yr 11 mo

  13. Patent 9050335 expires

    Listed drug product patent expiration.

    in 5 yr 11 mo

  14. Patent 9468636 expires

    Listed method-of-use patent (U-1499) expiration.

    in 5 yr 11 mo

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033TodayPatent 7976870: 2027-06-01Patent 7976870Patent 8372432: 2029-03-11Patent 8372432Patent 8394408: 2029-03-11Patent 8394408Patent 8668929: 2029-03-11Patent 8668929Patent 8377453: 2029-11-19Patent 8377453Patent 8597681: 2030-12-21Patent 8597681Patent 8980319: 2030-12-21Patent 8980319Patent 8658631: 2032-05-16Patent 8658631Patent 8741885: 2032-05-16Patent 8741885Patent 8992975: 2032-05-16Patent 8992975Patent 9050335: 2032-05-16Patent 9050335Patent 9468636: 2032-05-16Patent 9468636
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Strength

325MG;7.5MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 204031

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7976870in 10 mo
U-1498
8372432in 2 yr 8 mo
ProductU-1499
8394408in 2 yr 8 mo
Product
8668929in 2 yr 8 mo
U-1499
8377453in 3 yr 4 mo
ProductU-1499
8597681in 4 yr 6 mo
Product
8980319in 4 yr 6 mo
Product
8658631in 5 yr 11 mo
Product
8741885in 5 yr 11 mo
ProductU-1499
8992975in 5 yr 11 mo
Product
9050335in 5 yr 11 mo
Product
9468636in 5 yr 11 mo
U-1499

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 Acetaminophen; Oxycodone Hydrochloride 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.

Xartemis XR: 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 204031 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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