Case	Court	Filed	Status	Judge
Biovail Laboratories International SRL v. Watson Pharmaceuticals Inc. et al 1:2010cv00133 5 patentsANDA 091500bupropion hydrobromide	D. Del.	2010-02-18	Terminated 2010-04-15	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Aplenzin (2023)

Total Spending

$20.3M

Total Claims

4,330

Beneficiaries

741

Avg Cost/Unit

$124.96

Spending Trend

$10.8M(2019)→$14.1M(2020)→$15.3M(2021)→$18.3M(2022)→$20.3M(2023)

YoY Change:+2.8%

5yr CAGR:+5.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs3 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDBUPROPION HYDROBROMIDE

DMF 252542011

JUBILANT PHARMOVA LTDBUPROPION HYDROBROMIDE

DMF 267202013

HIKAL LTDBUPROPION HYDROBROMIDE (FORM-I)

DMF 382312023

HIKAL LTDBUPROPION HYDROBROMIDE (FORM II)

DMF 383842023

LUPIN MANUFACTURING SOLUTIONS LTDBUPROPION HYDROBROMIDE

DMF 392242023

HETERO DRUGS LTDBUPROPION HYDROBROMIDE

DMF 405832024

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDBUPROPION HYDROBROMIDE

DMF 409322024

ALIVUS LIFE SCIENCES LTDBUPROPION HYDROBROMIDE

DMF 416012025

ERREGIERRE SPAInactiveBUPROPION HYDROBROMIDE

DMF 224192009

DIPHARMA FRANCIS SRLInactiveBUPROPION HYDROBROMIDE

DMF 227202009

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDInactiveBUPROPION HYDROBROMIDE API

DMF 228092009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Nov 6, 2025	SUPPL -26	View Letter (PDF)
May 7, 2024	SUPPL -23	View Letter (PDF)
Mar 9, 2022	SUPPL -22	View Letter (PDF)
Jul 12, 2021	SUPPL -21	View Letter (PDF)
May 5, 2020	SUPPL -20	View Letter (PDF)
May 9, 2017	SUPPL -14	View Letter (PDF)
Aug 30, 2016	SUPPL -12	View Letter (PDF)
Jan 7, 2015	SUPPL -9	View Letter (PDF)
Jul 10, 2014	SUPPL -11	View Letter (PDF)
Aug 17, 2012	SUPPL -7	View Letter (PDF)
Jul 28, 2011	SUPPL -6	View Letter (PDF)
Jul 28, 2011	SUPPL -5	View Letter (PDF)
May 4, 2011	SUPPL -2	View Letter (PDF)
May 4, 2011	SUPPL -3	View Letter (PDF)
Apr 24, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 174MG

RLD

8 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 23, 2008

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7241805	Jun 27, 2026	—	—	Yes	—	—
7569610	Jun 27, 2026	—	—	—		—
7572935	Jun 27, 2026	—	—	Yes	—	—
7585897	Jun 27, 2026	—	—	Yes	—	—
7645802	Jun 27, 2026	—	—	Yes	—	—
7649019	Jun 27, 2026	—	—	Yes	—	—
7662407	Jun 27, 2026	—	—	Yes	—	—
7671094	Jun 27, 2026	—	—	Yes	—	—

#002 — 348MG

RLD

8 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 23, 2008

#003 — 522MG

RLD

8 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Apr 23, 2008