Viewing data from:

FORFIVO XL

NDA

BUPROPION HYDROCHLORIDE | N022497 | TWI PHARMACEUTICALS INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

7674479

Aug. 23, 2028

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Ajanta Pharma USA Inc. FDA-2025-P-4778 · 3 docket documents Ajanta Pharma USA Inc. filed this citizen petition under 21 CFR 10.25 and 10.30 requesting that the FDA determine whether FORFIVO XL (bupropion hydrochloride) extended-release tablets 450 mg, approved under NDA 022497 and held by TWI Pharmaceuticals Inc., was voluntarily withdrawn from the market fo	505(q)	2025-10-06	Open	Ajanta Pharma USA Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

262 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 216 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bupropion to Reduce Cancer Related Fatigue in Cancer Survivors NCT03996265	Phase 3	Active	University of Rochester NCORP Research Base	422	2019-06-27 → 2026-08-05
Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder NCT02129751	Phase 4	Not Yet Recruiting	Bausch Health Americas, Inc.	246	2026-06 → 2029-12
Bupropion for the Prevention of Postpartum Smoking Relapse NCT04098874	Phase 4	Recruiting	University of Minnesota	200	2020-01-01 → 2026-07-31
Optimizing Outcomes of Treatment-Resistant Depression in Older Adults NCT02960763	Phase 4	Completed	Washington University School of Medicine	742	2017-02-24 → 2021-09-01
The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion in Healthy Male Volunteers NCT02305901	Phase 1	Completed	Boehringer Ingelheim	18	2014-12 → 2015-03
Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions NCT03234699	Phase 1	Completed	SK Life Science, Inc.	24	2017-02-22 → 2017-07-31
Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia NCT02736474	Phase 4	Completed	Shanghai Mental Health Center	22	2016-05 → 2018-07
A Phase 1 Study to Evaluate Safety, Tolerability, PK, and PK Interactions of TBA-7371 NCT03199339	Phase 1	Completed	Global Alliance for TB Drug Development	74	2017-08-29 → 2018-07-08
The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity NCT00205946	Phase 1	Completed	Affective Neuroscience Laboratory	32	2005-04 → 2007-07
Smoking Cessation Intervention: Effectiveness in Primary Care NCT00296647	Phase 4	Completed	University of Wisconsin, Madison	1,346	2004-09 → 2010-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$7.82

per ea

Lowest NADAC/Unit

$7.82

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24979024806BUPROPION HCL XL 450 MG TABLET	$7.82	EA	Generic	—	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 | 3 NDCs (3 FSS)

Lowest Price

$55.11

Highest Price

$282.28

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
47781-0637-30BUPROPION HCL (FORFIVO XL) 450MG TAB,SA	$55.11	FSS	Upsher-Smith Laboratories, LLC	04/30/2026
24979-0247-06FORFIVO XL 450MG TAB	$282.28	FSS	Upsher-Smith Laboratories, LLC	04/30/2026
24979-0248-06BUPROPION HCL (FORFIVO XL) 450MG TAB,SA	$55.11	FSS	Upsher-Smith Laboratories, LLC	04/30/2026

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

Medicare Part D Spending

CMS annual spending data for Forfivo XL (2024)

Total Spending

$237K

Total Claims

355

Beneficiaries

Avg Cost/Unit

$14.64

Spending Trend

$1.1M(2019)→$782K(2020)→$635K(2021)→$544K(2022)→$414K(2023)→$237K(2024)

YoY Change:-6.9%

5yr CAGR:+0.4%

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

API Supply Chain27 active DMFs13 inactive

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

ERREGIERRE SPABUPROPION HYDROCHLORIDE USP

DMF 110541994

CHEMI SPABUPROPION HYDROCHLORIDE

DMF 118341996

OLON SPABUPROPION HYDROCHLORIDE

DMF 139271998

HIKAL LTDBUPROPION HYDROCHLORIDE USP

DMF 164762003

OLON SPABUPROPION HYDROCHLORIDE

DMF 177842004

ALIVUS LIFE SCIENCES LTDBUPROPION HYDROCHLORIDE USP

DMF 181632005

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDBUPROPION HYDROCHLORIDE USP

DMF 182002005

DIVIS LABORATORIES LTDBUPROPION HYDROCHLORIDE USP

DMF 183062005

APITORIA PHARMA PRIVATE LTDBUPROPION HYDROCHLORIDE USP

DMF 191532006

JUBILANT BIOSYS LTDBUPROPION HYDROCHLORIDE USP

DMF 198352006

SUN PHARMACEUTICAL INDUSTRIES LTDBUPROPION HYDROCHLORIDE USP

DMF 202102007

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDBUPROPION HYDROCHLORIDE USP

DMF 212222007

ALEMBIC PHARMACEUTICALS LTDBUPROPION HYDROCHLORIDE USP

DMF 220642008

AARTI PHARMALABS LTDBUPROPION HYDROCHLORIDE

DMF 272042013

HETERO DRUGS LTDBUPROPION HYDROCHLORIDE (PROCESS-II)

DMF 282972014

HIKAL LTDBUPROPION HYDROCHLORIDE USP [PROCESS-2]

DMF 284212014

CADILA PHARMACEUTICALS LTDBUPROPION HYDROCHLORIDE USP

DMF 285742014

ZYDUS LIFESCIENCES LTDBUPROPION HYDROCHLORIDE USP (PROCESS-II)

DMF 322482017

ZHEJIANG SHAXING TECHNOLOGY CO LTDBUPROPION HYDROCHLORIDE

DMF 342852019

CHEMECA DRUGS PRIVATE LTDBUPROPION HYDROCHLORIDE USP

DMF 354182020

GRANULES INDIA LTDBUPROPION HYDROCHLORIDE USP

DMF 356942021

SUN PHARMACEUTICAL INDUSTRIES LTDBUPROPION HYDROCHLORIDE USP (PROCESS-II)

DMF 394142024

EMNAR PHARMA PRIVATE LTDBUPROPION HYDROCHLORIDE

DMF 400882024

IPCA LABORATORIES LTDBUPROPION HYDROCHLORIDE USP

DMF 401462024

ZHEJIANG SYNCOZYMES BIO-PHARMACEUTICAL CO LTDBUPROPION HYDROCHLORIDE

DMF 420522025

MAHI DRUGS PRIVATE LTDBUPROPION HYDROCHLORIDE USP

DMF 433132026

APITORIA PHARMA PRIVATE LTDBUPROPION HYDROCHLORIDE USP (PROCESS-II)

DMF 433822026

NORDIC SYNTHESIS ABInactiveBUPROPION HYDROCHLORIDE

DMF 111961994

CILAG AGInactiveBUPROPION HYDROCHLORIDE

DMF 120891996

SOLMAG SPAInactiveBUPROPION HYDROCHLORIDE

DMF 138511998

SEVEN STAR PHARMACEUTICAL CO LTDInactiveBUPROPION HYDROCHLORIDE USP

DMF 177892004

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveBUPROPION HYDROCHLORIDE USP

DMF 179252004

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDInactiveBUPROPION HYDROCHLORIDE USP

DMF 181232005

PHARMACEUTICAL WORKS POLPHARMA SAInactiveBUPROPION HYDROCHLORIDE

DMF 181272005

CADILA HEALTHCARE LTDInactiveBUPROPION HYDROCHLORIDE

DMF 192972006

HANZHONG HANJIANG VENTUREPHARM PHARMACEUTICAL LTDInactiveBUPROPION HYDROCHLORIDE

DMF 194202006

ZHEJIANG XINHUA PHARMACEUTICAL CO LTDInactiveBUPROPION HYDROCHLORIDE

DMF 200852006

DERIVADOS QUIMICOS SAUInactiveBUPROPION HYDROCHLORIDE

DMF 237422010

HETERO DRUGS LTDInactiveBUPROPION HYDROCHLORIDE

DMF 267522012

LUPIN LTDInactiveBUPROPION HYDROCHLORIDE USP

DMF 335112019

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Nov 6, 2025	SUPPL -18	View Letter (PDF)
May 7, 2024	SUPPL -15	View Letter (PDF)
Dec 11, 2019	SUPPL -8	View Letter (PDF)
May 9, 2017	SUPPL -4	View Letter (PDF)
Jul 21, 2014	SUPPL -2	View Letter (PDF)
Nov 17, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 450MG

RLD

1 patent0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 10, 2011

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7674479	Aug 23, 2028	—	—	Yes	—	—