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Trokendi XR

topiramate · Capsule, Extended Release

Prescription NDA TE AB1 RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Trokendi XR
Generic name
topiramate
Dosage form
Capsule, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Supernus Pharmaceuticals, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
4
Packages
20
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Topiramate 100 mg/1 1302827 View
Topiramate 200 mg/1 1302827 View
Topiramate 25 mg/1 1302827 View
Topiramate 50 mg/1 1302827 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Extended Release
Route of administration
Oral
Presentations
24

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 2C19 Inhibitors [MoA] MoA All 93 members
Cytochrome P450 3A4 Inducers [MoA] MoA All 54 members
Decreased Central Nervous System Disorganized Electrical Activity [PE] PE All 114 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
201635
Application type
NDA · New Drug Application
Approval date
August 16, 2013
Sponsor
SUPERNUS PHARMS
Products on application
4
Submissions recorded
22
Products approved under application 201635.
Product Trade name Form Strength Ingredient Status TE Flags
201635-001 TROKENDI XR CAPSULE, EXTENDED RELEASE TOPIRAMATE Prescription AB1 RLD
201635-002 TROKENDI XR CAPSULE, EXTENDED RELEASE TOPIRAMATE Prescription AB1 RLD
201635-003 TROKENDI XR CAPSULE, EXTENDED RELEASE TOPIRAMATE Prescription AB1 RLD
201635-004 TROKENDI XR CAPSULE, EXTENDED RELEASE TOPIRAMATE Prescription AB1 RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB1
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8663683 November 16, 2027 001 No U-1992 —
8663683 November 16, 2027 001 No U-106 —
8992989 November 16, 2027 001 No U-1675 April 8, 2015
8889191 November 16, 2027 001 No U-106 December 17, 2014
9549940 November 16, 2027 001 No U-1992 January 27, 2017
8298580 November 16, 2027 001 No U-1992 August 22, 2013
8877248 November 16, 2027 001 No U-1992 November 12, 2014
8877248 November 16, 2027 001 No U-106 November 12, 2014
9555004 November 16, 2027 001 No U-1992 February 9, 2017
10314790 November 16, 2027 001 No U-1675 July 9, 2019
9622983 November 16, 2027 001 No U-1992 April 20, 2017
8992989 November 16, 2027 001 No U-1992 April 8, 2015
8889191 November 16, 2027 001 No U-1992 December 17, 2014
9549940 November 16, 2027 001 No U-1675 January 27, 2017
9622983 November 16, 2027 001 No U-1675 April 20, 2017
9555004 November 16, 2027 001 No U-1675 February 9, 2017
10314790 November 16, 2027 001 No U-1992 July 9, 2019
8298580 November 16, 2027 001 No U-106 August 22, 2013
9622983 November 16, 2027 002 No U-1992 April 20, 2017
9549940 November 16, 2027 002 No U-1992 January 27, 2017
8877248 November 16, 2027 002 No U-1992 November 12, 2014
8889191 November 16, 2027 002 No U-106 December 17, 2014
8889191 November 16, 2027 002 No U-1992 December 17, 2014
10314790 November 16, 2027 002 No U-1992 July 9, 2019
8298580 November 16, 2027 002 No U-106 August 22, 2013
8992989 November 16, 2027 002 No U-1675 April 8, 2015
9549940 November 16, 2027 002 No U-1675 January 27, 2017
9555004 November 16, 2027 002 No U-1992 February 9, 2017
8877248 November 16, 2027 002 No U-106 November 12, 2014
8663683 November 16, 2027 002 No U-106 —
8663683 November 16, 2027 002 No U-1992 —
8298580 November 16, 2027 002 No U-1992 August 22, 2013
8992989 November 16, 2027 002 No U-1992 April 8, 2015
9622983 November 16, 2027 002 No U-1675 April 20, 2017
9555004 November 16, 2027 002 No U-1675 February 9, 2017
10314790 November 16, 2027 002 No U-1675 July 9, 2019
9622983 November 16, 2027 003 No U-1992 April 20, 2017
9622983 November 16, 2027 003 No U-1675 April 20, 2017
8992989 November 16, 2027 003 No U-1992 April 8, 2015
9555004 November 16, 2027 003 No U-1992 February 9, 2017
8298580 November 16, 2027 003 No U-1992 August 22, 2013
8877248 November 16, 2027 003 No U-106 November 12, 2014
10314790 November 16, 2027 003 No U-1992 July 9, 2019
10314790 November 16, 2027 003 No U-1675 July 9, 2019
8992989 November 16, 2027 003 No U-1675 April 8, 2015
8889191 November 16, 2027 003 No U-1992 December 17, 2014
8663683 November 16, 2027 003 No U-106 —
9549940 November 16, 2027 003 No U-1992 January 27, 2017
8298580 November 16, 2027 003 No U-106 August 22, 2013
8877248 November 16, 2027 003 No U-1992 November 12, 2014
8889191 November 16, 2027 003 No U-106 December 17, 2014
8663683 November 16, 2027 003 No U-1992 —
9555004 November 16, 2027 003 No U-1675 February 9, 2017
9549940 November 16, 2027 003 No U-1675 January 27, 2017
9622983 November 16, 2027 004 No U-1992 April 20, 2017
8663683 November 16, 2027 004 No U-1992 —
8663683 November 16, 2027 004 No U-106 —
8992989 November 16, 2027 004 No U-1675 April 8, 2015
8298580 November 16, 2027 004 No U-1992 August 22, 2013
10314790 November 16, 2027 004 No U-1992 July 9, 2019
9622983 November 16, 2027 004 No U-1675 April 20, 2017
8889191 November 16, 2027 004 No U-106 December 17, 2014
8992989 November 16, 2027 004 No U-1992 April 8, 2015
9555004 November 16, 2027 004 No U-1675 February 9, 2017
8877248 November 16, 2027 004 No U-106 November 12, 2014
9549940 November 16, 2027 004 No U-1992 January 27, 2017
9549940 November 16, 2027 004 No U-1675 January 27, 2017
10314790 November 16, 2027 004 No U-1675 July 9, 2019
9555004 November 16, 2027 004 No U-1992 February 9, 2017
8877248 November 16, 2027 004 No U-1992 November 12, 2014
8889191 November 16, 2027 004 No U-1992 December 17, 2014
8298580 November 16, 2027 004 No U-106 August 22, 2013
8298576 April 4, 2028 001 No U-106 August 22, 2013
8298576 April 4, 2028 001 No U-1992 August 22, 2013
8298576 April 4, 2028 002 No U-1992 August 22, 2013
8298576 April 4, 2028 002 No U-106 August 22, 2013
8298576 April 4, 2028 003 No U-106 August 22, 2013
8298576 April 4, 2028 003 No U-1992 August 22, 2013
8298576 April 4, 2028 004 No U-1992 August 22, 2013
8298576 April 4, 2028 004 No U-106 August 22, 2013

Approval history

Source: Drugs@FDA
Most recent submissions on application 201635.
Type No. Action Status Date Review
Supplement 39 Labeling Approved March 6, 2026 Standard
Supplement 36 Labeling Approved March 10, 2025 Standard
Supplement 32 Labeling Approved January 4, 2024 Standard
Supplement 30 Labeling Approved October 7, 2022 Standard
Supplement 29 Labeling Approved February 3, 2022 Standard
Supplement 25 Labeling Approved November 18, 2020 Standard
Supplement 23 Manufacturing (CMC) Approved April 10, 2020 N/A
Supplement 20 Labeling Approved February 21, 2019 Standard
Supplement 18 Labeling Approved January 3, 2018 Standard
Supplement 17 Efficacy Approved April 5, 2017 Standard
Supplement 11 Efficacy Approved April 5, 2017 Standard
Supplement 15 Manufacturing (CMC) Approved December 22, 2016 Standard
Supplement 14 Efficacy Approved August 18, 2016 Standard
Supplement 13 Efficacy Tentative approval August 18, 2016 Standard
Supplement 12 Manufacturing (CMC) Approved March 16, 2016 Standard
Supplement 10 Manufacturing (CMC) Approved October 12, 2015 Standard
Supplement 7 Labeling Approved May 8, 2015 Standard
Supplement 6 Manufacturing (CMC) Approved April 17, 2015 Standard
Supplement 2 Manufacturing (CMC) Approved June 20, 2014 Standard
Supplement 4 Manufacturing (CMC) Approved April 18, 2014 Standard
Supplement 1 Manufacturing (CMC) Approved April 18, 2014 Standard
Original application 1 Type 3 - New Dosage Form Approved August 16, 2013 Standard

Review documents

  • 0 · Supplement · March 12, 2026
  • 0 · Supplement · March 9, 2026
  • 0 · Supplement · March 6, 2026
  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · May 1, 2025
  • 0 · Supplement · March 12, 2025
  • 0 · Supplement · March 11, 2025
  • 0 · Supplement · January 10, 2024
  • 0 · Supplement · January 5, 2024
  • 0 · Supplement · October 11, 2022
  • 0 · Supplement · October 11, 2022
  • 0 · Supplement · October 11, 2022
  • 0 · Supplement · February 7, 2022
  • 0 · Supplement · February 4, 2022
  • 0 · Supplement · November 19, 2020
  • 0 · Supplement · November 19, 2020
  • 0 · Supplement · February 22, 2019
  • 0 · Supplement · February 22, 2019
  • 0 · Supplement · January 9, 2018
  • 0 · Supplement · January 4, 2018
  • 0 · Supplement · April 12, 2017
  • 0 · Supplement · April 7, 2017
  • 0 · Supplement · April 7, 2017
  • 0 · Supplement · August 22, 2016
  • 0 · Supplement · August 18, 2016
  • 0 · Supplement · August 18, 2016
  • 0 · Supplement · June 5, 2015
  • 0 · Supplement · May 13, 2015
  • 0 · Original application · June 24, 2014
  • 0 · Original application · June 24, 2014

Adverse event reports

Source: openFDA FAERS
96,821
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: TOPIRAMATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
17772-101-01 17772-101 Supernus Pharmaceuticals, Inc. 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-101-01) August 16, 2013
17772-101-07 17772-101 Supernus Pharmaceuticals, Inc. 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-101-07) June 23, 2020
17772-101-10 17772-101 Supernus Pharmaceuticals, Inc. 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-101-10) August 16, 2013
17772-101-12 17772-101 Supernus Pharmaceuticals, Inc. 7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-101-12) August 16, 2013
17772-101-30 17772-101 Supernus Pharmaceuticals, Inc. 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-101-30) August 16, 2013
17772-102-01 17772-102 Supernus Pharmaceuticals, Inc. 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-01) August 16, 2013
17772-102-07 17772-102 Supernus Pharmaceuticals, Inc. 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-07) June 23, 2020
17772-102-10 17772-102 Supernus Pharmaceuticals, Inc. 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-10) August 16, 2013
17772-102-12 17772-102 Supernus Pharmaceuticals, Inc. 7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-12) August 16, 2013
17772-102-30 17772-102 Supernus Pharmaceuticals, Inc. 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-30) August 16, 2013
17772-103-01 17772-103 Supernus Pharmaceuticals, Inc. 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-01) August 16, 2013
17772-103-07 17772-103 Supernus Pharmaceuticals, Inc. 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-07) June 23, 2020
17772-103-10 17772-103 Supernus Pharmaceuticals, Inc. 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-10) August 16, 2013
17772-103-12 17772-103 Supernus Pharmaceuticals, Inc. 7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-103-12) August 16, 2013
17772-103-30 17772-103 Supernus Pharmaceuticals, Inc. 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-103-30) August 16, 2013
17772-104-01 17772-104 Supernus Pharmaceuticals, Inc. 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-104-01) August 16, 2013
17772-104-07 17772-104 Supernus Pharmaceuticals, Inc. 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-104-07) June 23, 2020
17772-104-10 17772-104 Supernus Pharmaceuticals, Inc. 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-104-10) August 16, 2013
17772-104-12 17772-104 Supernus Pharmaceuticals, Inc. 7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-104-12) August 16, 2013
17772-104-30 17772-104 Supernus Pharmaceuticals, Inc. 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-104-30) August 16, 2013
17772-101 17772-101 Supernus Pharmaceuticals, Inc. — August 16, 2013
17772-102 17772-102 Supernus Pharmaceuticals, Inc. — August 16, 2013
17772-103 17772-103 Supernus Pharmaceuticals, Inc. — August 16, 2013
17772-104 17772-104 Supernus Pharmaceuticals, Inc. — August 16, 2013

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.