Viewing data from:

NUEDEXTA

NDA

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | N021879 | OTSUKA AMERICA PHARMACEUTICAL INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)Today

Today

7659282

Aug. 13, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

4 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Otsuka America Pharmaceutical, Inc. et al v. Hetero Labs Limited et al 1:2025cv00647 1 patentANDA 218426dextromethorphan hydrobromide and quinidine sulfate	D. Del.	2025-05-27	Active	—
Avanir Pharmaceuticals Inc. et al v. Sandoz Inc. 1:2013cv00961 3 patentsANDA 203538dextromethorphan hydrobromide/quinidine sulfate	D. Del.	2013-05-30	Terminated 2013-08-20	—
Avanir Pharmaceuticals Inc. v. Impax Laboratories Inc. 1:2012cv01298 1 patentANDA 203061dextromethorphan hydrobromide/quinidine sulfate	D. Del.	2012-10-08	Terminated 2015-09-25	—
Avanir Pharmaceuticals Inc. et al v. Watson Pharmaceuticals Inc. et al 1:2012cv00258 2 patentsANDA 203538dextromethorphan hydrobromide/quinidine sulfate	D. Del.	2012-03-02	Terminated 2015-09-25	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Clinical Trial Nuedexta in Subjects With ALS NCT01806857	Phase 2	Completed	Center for Neurologic Study, La Jolla, California,	90	2013-04 → 2015-03
Nuedexta for the Treatment of Adults With Autism NCT01630811	Phase 2	Completed	Sutter Health	13	2012-01-24 → 2015-12-15
Study to Assess the Bioavailability, Pharmacokinetics, Safety, and Tolerability of AVP-923 in Healthy Adult Participants NCT03381664	Phase 1	Completed	Avanir Pharmaceuticals	17	2017-11-28 → 2018-01-30
Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS NCT00573443	Phase 3	Completed	Avanir Pharmaceuticals	326	2007-12 → 2009-09
Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)NCT02496039	Phase 4	Terminated	Avanir Pharmaceuticals	5	2015-09 → 2016-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$26.61

per ea

Lowest NADAC/Unit

$26.61

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
64597030160NUEDEXTA 20-10 MG CAPSULE	$26.61	EA	Brand	—	2026-06-17
59148005316NUEDEXTA 20-10 MG CAPSULE	$26.61	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1193.83

Highest Price

$1230.40

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64597-0301-60NUEDEXTA	$1230.40	FSS	Otsuka America Pharmaceutical, Inc.	03/14/2026
64597-0301-60NUEDEXTA	$1193.83	Big4	Otsuka America Pharmaceutical, Inc.	03/14/2026
59148-0053-16NUEDEXTA	$1230.40	FSS	Otsuka America Pharmaceutical, Inc.	03/14/2026
59148-0053-16NUEDEXTA	$1193.83	Big4	Otsuka America Pharmaceutical, Inc.	03/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Nuedexta (2024)

Total Spending

$173.0M

Total Claims

158,337

Beneficiaries

15,788

Avg Cost/Unit

$26.85

Spending Trend

$234.6M(2019)→$212.6M(2020)→$187.5M(2021)→$183.2M(2022)→$180.6M(2023)→$173.0M(2024)

YoY Change:+0.7%

5yr CAGR:+5.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jun 12, 2019	SUPPL -14	View Letter (PDF)
Feb 13, 2019	SUPPL -12	View Letter (PDF)
Jan 21, 2015	SUPPL -5	View Letter (PDF)
Nov 3, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG;10MG

RLDAB

1 patent0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 29, 2010

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7659282	Aug 13, 2026	—	—	—		—