Is there a generic for Bupropion hydrobromide?

The FDA Orange Book does not currently list an approved generic (ANDA) for Bupropion hydrobromide. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Bupropion hydrobromide?

APLENZIN (NDA 022108, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Bupropion hydrobromide?

The Orange Book lists 8 patents against Bupropion hydrobromide 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 Bupropion hydrobromide are approved?

Bupropion hydrobromide is approved in the following dosage form: tablet, extended release.

FDA Orange Book · active-ingredient family

Bupropion hydrobromide

Bupropion hydrobromide: 1 brand, 0 generics; first approved Apr 23, 2008; on patent until Jun 27, 2026.

On patent

Generic status & protection

Protected until Jun 27, 2026 (earliest listed patent expiry).

Earliest patent expiry Jun 27, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jun 27, 2026

16 d ago

Originator applications

Brand (NDA) products

APLENZINRLD

BAUSCHNDA 02210820083 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
174MG	TABLET, EXTENDED RELEASE	ORAL	Rx	—
348MG	TABLET, EXTENDED RELEASE	ORAL	Rx	—
522MG	TABLET, EXTENDED RELEASE	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7569610	Jun 27, 2026	16 d ago	U-997
7241805	Jun 27, 2026	16 d ago	Product
7645802	Jun 27, 2026	16 d ago	Product
7585897	Jun 27, 2026	16 d ago	Product
7662407	Jun 27, 2026	16 d ago	Product
7572935	Jun 27, 2026	16 d ago	Product
7649019	Jun 27, 2026	16 d ago	Product
7671094	Jun 27, 2026	16 d ago	Product

FDA approval span

Approval history

First approval

Apr 23, 2008

18 yr 6 mo ago

Most recent approval

Apr 23, 2008

18 yr 6 mo ago

All 1 application were approved in 2008.

Brand (NDA) 1100%

Generic (ANDA) 00%

Bupropion hydrobromide — 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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