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Orange Book drug · Brand (NDA)

Adhansia XR

Methylphenidate Hydrochloride

DiscontinuedRLDNDA 212038 6 strengths Knoa Pharma
Approved
Feb 27, 2019
Strengths
6
Listed patents
12

What does the FDA Orange Book show for Adhansia XR?

Adhansia XR contains Methylphenidate Hydrochloride and is the new drug FDA Orange Book record for NDA 212038. The application has 6 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 212038

New drug application identity from the Orange Book snapshot.

Application holder
Knoa Pharma LLC

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

Product presentations
6

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
00125MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD
00235MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD
00345MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD
00455MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD
00570MGCAPSULE, EXTENDED RELEASEORALDiscontinuedNone posted
RLD
00685MGCAPSULE, 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

Knoa Pharma LLC

The Orange Book identifies this organization as the applicant responsible for NDA 212038.

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

6 presentations 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 Nov 19, 2038. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

72 other ANDAs and 12 other NDAs found

45 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 212038 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-212038

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

6 approved presentations · NDA 212038
RLDDiscontinued
Strength
25MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Discontinued

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    7 yr 6 mo ago

  2. Today

  3. Patent 10111839 expires

    Listed method-of-use patent (U-2357) expiration.

    in 9 yr 5 mo

  4. Patent 10292938 expires

    Listed drug product patent expiration.

    in 9 yr 5 mo

  5. Patent 10292939 expires

    Listed drug product patent expiration.

    in 9 yr 5 mo

  6. Patent 10449159 expires

    Listed method-of-use patent (U-2357) expiration.

    in 9 yr 5 mo

  7. Patent 10500162 expires

    Listed method-of-use patent (U-2357) expiration.

    in 9 yr 5 mo

  8. Patent 10507186 expires

    Listed drug product patent expiration.

    in 9 yr 5 mo

  9. Patent 10512612 expires

    Listed drug product patent expiration.

    in 9 yr 5 mo

  10. Patent 10512613 expires

    Listed method-of-use patent (U-2357) expiration.

    in 9 yr 5 mo

  11. Patent 10568841 expires

    Listed drug product patent expiration.

    in 9 yr 5 mo

  12. Patent 10688060 expires

    Listed drug product patent expiration.

    in 9 yr 5 mo

  13. Patent 9974752 expires

    Listed drug product patent expiration.

    in 9 yr 5 mo

  14. Patent 10722473 expires

    Listed method-of-use patent (U-2357) expiration.

    in 12 yr 6 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayPatent 10111839: 2035-10-30Patent 10111839Patent 10292938: 2035-10-30Patent 10292938Patent 10292939: 2035-10-30Patent 10292939Patent 10449159: 2035-10-30Patent 10449159Patent 10500162: 2035-10-30Patent 10500162Patent 10507186: 2035-10-30Patent 10507186Patent 10512612: 2035-10-30Patent 10512612Patent 10512613: 2035-10-30Patent 10512613Patent 10568841: 2035-10-30Patent 10568841Patent 10688060: 2035-10-30Patent 10688060Patent 9974752: 2035-10-30Patent 9974752Patent 10722473: 2038-11-19Patent 10722473
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

METHYLPHENIDATE HYDROCHLORIDE

Strength

25MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 212038

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
10111839in 9 yr 5 mo
U-2357
10292938in 9 yr 5 mo
Product
10292939in 9 yr 5 mo
ProductU-2357
10449159in 9 yr 5 mo
U-2357
10500162in 9 yr 5 mo
U-2357
10507186in 9 yr 5 mo
Product
10512612in 9 yr 5 mo
Product
10512613in 9 yr 5 mo
U-2357
10568841in 9 yr 5 mo
ProductU-2357
10688060in 9 yr 5 mo
Product
9974752in 9 yr 5 mo
Product
10722473in 12 yr 6 mo
U-2357

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 Methylphenidate 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.

Adhansia 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 212038 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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