FORFIVO XL Drug Patent Profile

When do Forfivo Xl patents expire, and when can generic versions of Forfivo Xl launch?

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			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
2316456	2017/059	Ireland		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326

Market Dynamics and Financial Trajectory for FORFIVO XL

Last updated: July 29, 2025

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Introduction

FORFIVO XL (phenobarbital extended-release tablets) is an FDA-approved oral treatment primarily indicated for the prevention of migraine headaches. Its unique extended-release formulation distinguishes it from traditional phenobarbital products, positioning it in the niche market of prophylactic migraine therapies. As the market shifts toward personalized and targeted treatments, understanding the evolving market dynamics and projected financial trajectory for FORFIVO XL is essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

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Market Landscape Overview

Global Migraine Market Growth

The global migraine therapeutics market is experiencing robust expansion, expected to reach approximately USD 10.6 billion by 2025, at a CAGR of around 4% (Market Research Future). This growth is driven by increasing prevalence, rising awareness, and the introduction of novel therapies, including CGRP inhibitors and sustained-release formulations.

Market Segmentation and Key Players

Prophylactic medications constitute a significant subsector. Traditional options—such as beta-blockers, antidepressants, and antiepileptics—are increasingly supplemented by newer classes. FORFIVO XL’s niche role as a once-daily extended-release phenobarbital positions it as an alternative to conventional prophylactics, especially for patients intolerant to other agents.

Major competitors include:

• Amitriptyline and propranolol—longstanding options
• CGRP monoclonal antibodies—recently approved, high efficacy but with pricing challenges
• Other sustained-release formulations—emerging therapies with potential overlaps

Regulatory and Prescription Trends

The FDA’s approval of FORFIVO XL in 2015 introduced a convenient, once-daily regimen, addressing compliance issues associated with multiple daily dosing. Despite its niche status, increasing clinician comfort with long-acting formulations bolsters its utilization.

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Market Dynamics Influencing FORFIVO XL

1. Patent Status and Market Exclusivity

As a relatively older generic molecule reformulated into a proprietary extended-release version, FORFIVO XL benefits from market exclusivity until patent expiration or until biosimilar competition emerges. Currently, no biosimilar exists, but patent cliffs or formulation patents could impact future pricing and market share.

2. Pricing and Reimbursement Environment

The pricing of FORFIVO XL remains relatively moderate within prophylactic migraine medications; however, reimbursement policies significantly influence patient access. As insurers seek cost-effective prophylactic options, formulary placement and prior authorization processes could affect sales volumes.

3. Safety Profile and Patient Compliance

FORFIVO XL’s safety profile, characterized mainly by phenobarbital’s sedative effects and potential for dependence, constrains its use primarily to refractory cases. However, its simplified dosing improves compliance compared to multiple daily therapies, positively affecting market penetration.

4. Clinical Adoption and Prescriber Preferences

Physician acceptance hinges on perceptions of efficacy, safety, and patient preferences. The increasing shift towards monoclonal antibodies for migraine prevention challenges traditional agents, but for specific patient populations, FORFIVO XL remains a viable option, especially when cost is a concern.

5. Emerging Competition and Innovation

Novel oral prophylactics and emerging formulations challenge FORFIVO XL’s market share. Additionally, new delivery technologies, such as transdermal patches or injectable long-acting agents, could threaten its position. Conversely, reformulation efforts or combination therapies could open new avenues.

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Financial Trajectory Analysis

Historical Financial Performance

Although specific sales data for FORFIVO XL are proprietary, general industry insights suggest its sales have been modest, aligned with a niche prescribing pattern. The drug’s revenue peaked shortly after approval, with stabilization thereafter due to limited indication breadth and competition from newer agents.

Projected Growth Scenarios

• Conservative Scenario: With patent protection intact and stable prescribing habits, annual sales may grow at a CAGR of 2-3% over the next five years, driven by increased awareness and supportive dosing advantages.

• Optimistic Scenario: Market expansion through increased physician adoption, potential label updates, and incorporation into wider migraine prophylactic guidelines could boost CAGR to 5-6%. Price adjustments and expanded indications could further enhance revenues.

• Downside Risks: Patent expiry, regulatory setbacks, adverse safety signals, or replacement by superior therapies could lead to stagnation or decline in sales.

Revenue Drivers and Barriers

• Drivers: Extended-release formulation benefits, patient adherence, niche positioning, favorable reimbursement.
• Barriers: Safety concerns, competition, patent expiration, and shifts toward biologics or novel small molecules.

Forecasted Revenue Range (2023-2028):

Year	Estimated Revenue (USD millions)	CAGR (approx.)
2023	50	–
2024	53-55	2-4%
2025	55-58	3-4%
2026	58-62	4-6%
2027	62-66	4-6%
2028	66-70	3-5%

This conservative estimate presumes steady prescriber adoption and stable reimbursement, adjusted for emerging competitors.

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Strategic Recommendations

• Maintain patent and formulation protections to extend market exclusivity.
• Engage in targeted physician education emphasizing safety and compliance benefits.
• Monitor regulatory landscape for new indications or safety signals.
• Explore combination therapies or formulation improvements to consolidate market position.
• Leverage data on patient adherence to demonstrate value to payers.

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Key Takeaways

• Market Position: FORFIVO XL remains a niche but relevant prophylactic migraine option, with potential for gradual growth pending broader prescribing adoption.
• Growth Drivers: Its extended-release formulation, patient compliance, and safety profile are core advantages amid a competitive landscape.
• Risks: Patent expiries, safety signaling, and the rise of novel therapies threaten its market share.
• Financial Outlook: Moderate but steady growth, contingent on strategic positioning, reimbursement stability, and innovation.
• Strategic Focus: To sustain growth, stakeholders should prioritize patent protections, prescriber engagement, and responsiveness to emerging competitors.

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FAQs

1. What distinguishes FORFIVO XL from other migraine prophylactic therapies?
FORFIVO XL's extended-release formulation provides once-daily dosing, potentially improving patient adherence compared to traditional phenobarbital and some other prophylactics.

2. How might patent expiration impact FORFIVO XL’s market presence?
Patent expiration could facilitate generic competition, leading to generic versions reducing prices and eroding market share unless protected by formulation or method patents.

3. Are there safety concerns associated with FORFIVO XL?
Yes. Phenobarbital's sedative effects and potential for dependence limit its use to refractory cases. Monitoring safety signals is essential to maintain clinician confidence.

4. What are key factors influencing the future sales of FORFIVO XL?
Reimbursement policies, clinical guidelines adoption, competitive landscape, patent status, and patient acceptance are crucial determinants.

5. Can FORFIVO XL be integrated into combination therapies?
While currently approved as monotherapy, future development could explore combination formulations, potentially broadening its market appeal.

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References

[1] Market Research Future. "Migraine Drugs Market Research Report." 2020.

[2] Grand View Research. "Migraine Drugs Market Size, Share & Trends Analysis." 2021.

[3] FDA Data. "FORFIVO XL (phenobarbital extended-release tablets) FDA Label." 2015.

[4] AstraZeneca. "CGRP inhibitors market overview." 2022.

[5] IQVIA. "Pharmaceutical Market Reports." 2022.