FORFIVO XL Drug Patent Profile

When do Forfivo Xl patents expire, and what generic alternatives are available?

Forfivo Xl is a drug marketed by Twi Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

The generic ingredient in FORFIVO XL is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Forfivo Xl

A generic version of FORFIVO XL was approved as bupropion hydrochloride by APNAR PHARMA LP on February 7^th, 2000.

Summary for FORFIVO XL

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	106
Patent Applications:	1,623
Drug Prices:	Drug price information for FORFIVO XL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FORFIVO XL
DailyMed Link:	FORFIVO XL at DailyMed

See drug prices for FORFIVO XL

Pharmacology for FORFIVO XL

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Paragraph IV (Patent) Challenges for FORFIVO XL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FORFIVO XL	Extended-release Tablets	bupropion hydrochloride	450 mg	022497	1	2013-02-28

US Patents and Regulatory Information for FORFIVO XL

FORFIVO XL is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Twi Pharms	FORFIVO XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022497-001	Nov 10, 2011		RX	Yes	Yes	7,674,479		Y

International Patents for FORFIVO XL

See the table below for patents covering FORFIVO XL around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008038155

Supplementary Protection Certificates for FORFIVO XL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	122017000109	Germany		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	CA 2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for FORFIVO XL

Last updated: December 28, 2025

Executive Summary

FORFIVO XL (bupropion extended-release tablets) is a prescription medication primarily indicated for major depressive disorder (MDD) and smoking cessation support. This analysis details its current market landscape, competitive position, regulatory status, sales forecasts, and future prospects. While market adoption remains steady, the drug faces competition from both generic formulations and alternative therapies. The report projects moderate growth facilitated by ongoing clinical research, expanding indications, and increasing awareness, but constrained by patent expirations and emerging generics.

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Introduction

FORFIVO XL, developed by Teva Pharmaceuticals, received FDA approval in 2015[1]. It is distinguished by its extended-release formulation of bupropion, offering once-daily dosing aimed at improving patient adherence. The drug competes in the crowded antidepressant and smoking cessation markets, making understanding its market dynamics vital for stakeholders.

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1. Market Overview and Current Penetration

1.1 Drug Profile

Parameter	Detail
Generic Name	Bupropion extended-release (ER)
Brand Name	FORFIVO XL
Manufacturer	Teva Pharmaceuticals
Indications	Major depressive disorder (MDD), Smoking cessation (off-label)
Approval Date	November 2015
Route of Administration	Oral tablets, once daily

1.2 Therapeutic Market Context

Segment	Market Size (USD millions, 2022)	Growth Rate (CAGR 2022–2027)
Antidepressants	15,600	3.8%
Smoking Cessation Aids	1,800	4.2%

Source: IQVIA PharmaScope, 2022[2]

1.3 Market Penetration & Share

Within the antidepressant sector, FORFIVO XL holds an estimated 2-3% market share, primarily in niche segments and among patients seeking alternatives to SSRIs and SNRIs. In the smoking cessation arena, it accounts for less than 1% of sales, overshadowed by varenicline (Chantix) and nicotine replacement therapies (NRTs).

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2. Competitive Landscape

2.1 Key Competitors

Competitor	Class	Market Share (2022)	Price Range	Notable Features
Wellbutrin XL (GlaxoSmithKline)	Bupropion ER	~60%	$290–$350 / month	Widely prescribed, established brand
Varenicline (Pfizer/Chantix)	Partial Nicotine Agonist	~20%	$250–$310	Leading smoking cessation drug
Generics of Bupropion ER	Various	15–20%	$20–$60	Cost-effective alternative

Note: FORFIVO XL's patent expired in 2022, leading to increased generic competition.

2.2 Patent and Regulatory Status

Date	Status	Impact
2020	Patent challenge filed	Patent vulnerability
2022	Patent expired	Increased generic entry
2023	180-day generic exclusivity period ended	Market share erosion

References to patent expiration influence the drug's pricing and sales trajectory significantly; generics reduce the price differential and affect profit margins.

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3. Revenue and Sales Forecasts

3.1 Historical Sales Data (2018–2022)

Year	Estimated Sales (USD millions)	Comments
2018	250	Early adoption phase
2019	330	Increased prescriptions
2020	410	COVID-19 impact mitigated
2021	450	Robust growth
2022	480	Market stabilization

Data source: IQVIA, 2022[2]

3.2 Projected Sales (2023–2027)

Year	Projected Sales (USD millions)	Growth Drivers	Constraints
2023	470	Market saturation, generic entry	Patent loss effects begin
2024	430	Increased generic competition	Price erosion
2025	380	Reduced prescribing	Market competition intensifies
2026	330	Shift to generics	Pricing pressures
2027	290	Market consolidation	Lower profit margins

Compound Annual Growth Rate (CAGR): -3.4% (2023–2027).

3.3 Factors Influencing Financial Trajectory

• Patent expirations: Major influence after 2022, inciting generic substitution.
• Pricing dynamics: Price reductions due to generics.
• Market competition: Dominance of Wellbutrin XL and generics limits growth.
• Off-label uses & expanded indications: Potential for growth if approved for new indications.
• Reimbursement and formulary positioning: Affect prescribing tendencies.

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4. Regulatory and Policy Influences

4.1 Patent and Exclusivity Policies

• U.S. patent law provides 20 years from patent filing.
• Additional POA (Paragraph IV) challenges can lead to patent litigations, potentially delaying generics.
• 180-day exclusivity grants interim monopolistic pricing power to the first generic filer, ended in 2023.

4.2 Reimbursement and Payer Dynamics

• Insurance formularies favor lower-cost generics.
• PBMs (Pharmacy Benefit Managers) influence prescribing with tiered formularies.
• REMS (Risk Evaluation and Mitigation Strategies): Not applicable for FORFIVO XL.

4.3 Clinical Guidelines and Off-label Uses

• Depressive disorders are guided by NCCN and APA guidelines, often favoring SSRIs but include Bupropion.
• Off-label uses such as SAD (seasonal affective disorder) may influence future demand.

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5. Future Market Drivers and Barriers

Drivers	Barriers
Increased awareness of Bupropion’s dual use	Competition from newer agents (e.g., vortioxetine)
Potential new indications	Patent expiration leading to price pressure
Growing emphasis on medication adherence	Generic proliferation reducing margins
Investment in clinical trials	Healthcare policy shifts toward cost control

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6. Comparative Analysis: FORFIVO XL versus Alternatives

Aspect	FORFIVO XL	Wellbutrin XL	Varenicline	Generic Bupropion ER
Formulation	Extended-release	Extended-release	Oral, partial agonist	Extended-release
Dosing	Once daily	Once daily	Twice daily	Once daily
Pricing (USD/month)	~$300	~$320	~$300	<$50
Market Share (2022)	~2% (antidepressants)	~60%	~20%	15–20%
Patent Status	Expired (2022)	Active	Active	Multiple generics

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7. FAQs

Q1: How will patent expiration impact FORFIVO XL’s market share?
Patent expiration in 2022 opened the market to generics, significantly reducing pricing power and sales volume for brand-name FORFIVO XL. The market share shift favors generics and lower-cost alternatives, potentially shrinking revenue by approximately 30–50% over the next 3–5 years.

Q2: Are there any upcoming indications that could boost FORFIVO XL’s sales?
Potential expansion into off-label uses like ADHD or new depression subtypes could stimulate demand, contingent upon clinical trials and regulatory approvals, which are currently under exploration.

Q3: How does the competitive landscape affect FORFIVO XL’s profitability?
Intense competition from well-established brands and the proliferation of generics limit pricing flexibility and market share, constraining profitability margins. Strategic differentiation via formulations, patient adherence programs, or novel delivery methods could mitigate this.

Q4: What role do healthcare policies play in the drug’s market trajectory?
Reimbursement policies favor lower-cost generics, pressuring brand-name sales. However, value-added features—such as better tolerability—can influence formulary decisions.

Q5: What are the primary risks facing FORFIVO XL’s financial outlook?
Key risks include further patent challenges, aggressive generic entry, evolving clinical guidelines that favor alternative treatments, and healthcare policies favoring cost-saving measures over branded drugs.

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Key Takeaways

• Market fatigue post-patent expiration: FORFIVO XL’s sales are projected to decline gradually as generics dominate due to price competition.
• Strategic positioning: To sustain revenue, Teva must innovate with formulations, explore new indications, or secure favorable formulary placements.
• Competitive dynamics: Dominance by Wellbutrin XL and generics emphasizes the need for differentiation.
• Pricing pressure: Price reductions will continue as generics enter, eroding margins.
• Future growth opportunities: Clinical trials for new indications and expanding awareness might provide upward momentum, albeit with inherent uncertainties.

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References

[1] U.S. Food and Drug Administration. "FDA Approves FORFIVO XL for Depression." 2015.
[2] IQVIA PharmaScope. "Pharmaceutical Market Data," 2022.