Is there a generic for Dextromethorphan hydrobromide; quinidine sulfate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Dextromethorphan hydrobromide; quinidine sulfate, referencing the brand NUEDEXTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dextromethorphan hydrobromide; quinidine sulfate?

NUEDEXTA (NDA 021879, OTSUKA AMERICA PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Dextromethorphan hydrobromide; quinidine sulfate?

The Orange Book lists 1 patent against Dextromethorphan hydrobromide; quinidine sulfate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Dextromethorphan hydrobromide; quinidine sulfate are approved?

Dextromethorphan hydrobromide; quinidine sulfate is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Dextromethorphan hydrobromide; quinidine sulfate

Dextromethorphan hydrobromide; quinidine sulfate: 1 brand, 3 generics; first approved Oct 29, 2010; generic available.

Generic available

Generic status & protection

Generic available — 3 ANDA applications approved.

Earliest patent expiry Aug 13, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 13, 2026

in 1 mo

Originator applications

Brand (NDA) products

NUEDEXTARLDRS

OTSUKA AMERICA PHARMNDA 0218792010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG;10MG	CAPSULE	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (3)

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

SUN PHARMANDA 2041962026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG;10MG	CAPSULE	ORAL	Rx	AB

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

HETERO LABS LTD IIIANDA 2184262024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG;10MG	CAPSULE	ORAL	Rx	AB

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

ACTAVIS ELIZABETHANDA 2029342017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG;10MG	CAPSULE	ORAL	Rx	AB

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7659282	Aug 13, 2026	in 1 mo	U-1093

FDA approval span

Approval history

First approval

Oct 29, 2010

15 yr 11 mo ago

Most recent approval

Jun 03, 2026

1 mo ago

Approvals span 2010–2026 across 4 FDA applications.

Brand (NDA) 125%

Generic (ANDA) 375%

Dextromethorphan hydrobromide; quinidine sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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