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Orange Book drug · Brand (NDA)

Trokendi XR

Topiramate

RLDNDA 201635 4 strengths Supernus Pharms
Approved
Aug 16, 2013
Strengths
4
Listed patents
10

What does the FDA Orange Book show for Trokendi XR?

Trokendi XR contains Topiramate and is the new drug FDA Orange Book record for NDA 201635. 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 201635

New drug application identity from the Orange Book snapshot.

Application holder
Supernus Pharmaceuticals 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

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
AB1

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

Listed patents
10

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 RELEASEORALPrescriptionAB1
RLD
00250MGCAPSULE, EXTENDED RELEASEORALPrescriptionAB1
RLD
003100MGCAPSULE, EXTENDED RELEASEORALPrescriptionAB1
RLD
004200MGCAPSULE, EXTENDED RELEASEORALPrescriptionAB1
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

Supernus Pharmaceuticals Inc

The Orange Book identifies this organization as the applicant responsible for NDA 201635.

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

4 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 AB1 across rated presentations

FDA considers products with the same AB1 code therapeutically equivalent within the same active ingredient, dosage form, route, and strength heading. A different numbered AB code is a different equivalence group.

Patent & exclusivity record

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

The latest future date recorded across those files is Apr 04, 2028. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

51 other ANDAs and 4 other NDAs found

33 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 201635 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-201635

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 201635
TE AB1RLD
Strength
25MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    13 yr 2 mo ago

  2. Today

  3. Patent 10314790 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  4. Patent 10314790 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  5. Patent 8298580 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  6. Patent 8298580 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  7. Patent 8663683 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  8. Patent 8663683 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  9. Patent 8877248 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  10. Patent 8877248 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  11. Patent 8889191 expires

    Listed method-of-use patent (U-106) expiration.

    in 1 yr 4 mo

  12. Patent 8889191 expires

    Listed method-of-use patent (U-1992) expiration.

    in 1 yr 4 mo

  13. Patent 8992989 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  14. Patent 8992989 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  15. Patent 9549940 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  16. Patent 9549940 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  17. Patent 9555004 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  18. Patent 9555004 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  19. Patent 9622983 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  20. Patent 9622983 expires

    Listed drug product patent expiration.

    in 1 yr 4 mo

  21. Patent 8298576 expires

    Listed drug product patent expiration.

    in 1 yr 9 mo

  22. Patent 8298576 expires

    Listed drug product patent expiration.

    in 1 yr 9 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029TodayPatent 10314790: 2027-11-16Patent 10314790Patent 10314790: 2027-11-16Patent 10314790Patent 8298580: 2027-11-16Patent 8298580Patent 8298580: 2027-11-16Patent 8298580Patent 8663683: 2027-11-16Patent 8663683Patent 8663683: 2027-11-16Patent 8663683Patent 8877248: 2027-11-16Patent 8877248Patent 8877248: 2027-11-16Patent 8877248Patent 8889191: 2027-11-16Patent 8889191Patent 8889191: 2027-11-16Patent 8889191Patent 8992989: 2027-11-16Patent 8992989Patent 8992989: 2027-11-16Patent 8992989Patent 9549940: 2027-11-16Patent 9549940Patent 9549940: 2027-11-16Patent 9549940Patent 9555004: 2027-11-16Patent 9555004Patent 9555004: 2027-11-16Patent 9555004Patent 9622983: 2027-11-16Patent 9622983Patent 9622983: 2027-11-16Patent 9622983Patent 8298576: 2028-04-04Patent 8298576Patent 8298576: 2028-04-04Patent 8298576
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

TOPIRAMATE

Strength

25MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB1

Application

NDA 201635

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
10314790in 1 yr 4 mo
ProductU-1675
10314790in 1 yr 4 mo
ProductU-1992
8298580in 1 yr 4 mo
ProductU-1992
8298580in 1 yr 4 mo
ProductU-106
8663683in 1 yr 4 mo
ProductU-1992
8663683in 1 yr 4 mo
ProductU-106
8877248in 1 yr 4 mo
ProductU-1992
8877248in 1 yr 4 mo
ProductU-106
8889191in 1 yr 4 mo
U-106
8889191in 1 yr 4 mo
U-1992
8992989in 1 yr 4 mo
ProductU-1675
8992989in 1 yr 4 mo
ProductU-1992
9549940in 1 yr 4 mo
ProductU-1992
9549940in 1 yr 4 mo
ProductU-1675
9555004in 1 yr 4 mo
ProductU-1992
9555004in 1 yr 4 mo
ProductU-1675
9622983in 1 yr 4 mo
ProductU-1992
9622983in 1 yr 4 mo
ProductU-1675
8298576in 1 yr 9 mo
ProductU-106
8298576in 1 yr 9 mo
ProductU-1992

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 Topiramate 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.

Trokendi 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 201635 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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