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Orange Book drug · Brand (NDA)

Cotempla Xr-odt

Methylphenidate

RLDNDA 205489 4 strengths Neos Theraps Inc
Approved
Jun 19, 2017
Strengths
4
Listed patents
4

What does the FDA Orange Book show for Cotempla Xr-odt?

Cotempla Xr-odt contains Methylphenidate and is the new drug FDA Orange Book record for NDA 205489. The application has 4 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 205489

New drug application identity from the Orange Book snapshot.

Application holder
Neos Therapeutics Inc

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

Product presentations
4

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

Marketing categories
Prescription and Discontinued

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
4

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
0018.6MGTABLET, ORALLY DISINTEGRATING, EXTENDED RELEASEORALPrescriptionAB
RLD
00217.3MGTABLET, ORALLY DISINTEGRATING, EXTENDED RELEASEORALPrescriptionAB
RLD
00325.9MGTABLET, ORALLY DISINTEGRATING, EXTENDED RELEASEORALPrescriptionAB
RLDRS
00434.6MGTABLET, ORALLY DISINTEGRATING, 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

Neos Therapeutics Inc

The Orange Book identifies this organization as the applicant responsible for NDA 205489.

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

Status varies by presentation: 3 prescription and 1 on the Discontinued Drug Product List

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

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. 1 presentation in the application has no posted TE code.

Patent & exclusivity record

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

The latest future date recorded across those files is Jan 25, 2038. 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 1 other NDA 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 205489 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, Orally Disintegrating, Extended Release · Oral

Methylphenidate

2 applications
Product rows
7
Active applications
2
Active with AB row
2
Methylphenidate · ANDA 210924

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-205489

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

4 approved presentations · NDA 205489
TE ABRLD
Strength
8.6MG
Dosage form
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    9 yr 3 mo ago

  2. Patent 8840924 expires

    Listed drug product patent expiration.

    2 mo ago

  3. Today

  4. Patent 9072680 expires

    Listed drug product patent expiration.

    in 6 yr

  5. Patent 9089496 expires

    Listed drug product patent expiration.

    in 6 yr

  6. Patent 11166947 expires

    Listed method-of-use patent (U-3299) expiration.

    in 11 yr 8 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038TodayPatent 8840924: 2026-06-05Patent 8840924Patent 9072680: 2032-06-28Patent 9072680Patent 9089496: 2032-06-28Patent 9089496Patent 11166947: 2038-01-25Patent 11166947
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

METHYLPHENIDATE

Strength

8.6MG

Dosage form

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

NDA 205489

Product number

001

Marketing status

Prescription

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
88409242 mo ago
Product
9072680in 6 yr
Product
9089496in 6 yr
Product
11166947in 11 yr 8 mo
U-3299

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 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.

Cotempla Xr-odt: 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 205489 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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