FORFIVO XL Drug Patent Profile

Which patents cover Forfivo Xl, 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-two 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FORFIVO XL

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	349 22-2017	Slovakia		PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	C201730057	Spain		PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330

Forfivo XL: Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

What is Forfivo XL?

Forfivo XL is a prescription medication used for treatment of major depressive disorder (MDD). It contains sustained-release formulations of bupropion, an antidepressant classified as a norepinephrine-dopamine reuptake inhibitor (NDRI). The drug is marketed by Ajinomoto/Rite Aid.

Market Overview and Position

• Indication: Major depressive disorder
• Formulation: 450 mg sustained-release bupropion
• Pricing: Average wholesale price (AWP) around $500 per month (reflective of similar formulations)
• Competition: Includes Wellbutrin XL (bupropion extended-release), Prozac, Zoloft, and newer agents like SNRIs and SSRIs

Market size estimates for depression treatments in the US reached approximately $3.5 billion in 2022, with sustained-release forms comprising roughly 30% of the market.

Key Market Dynamics

• Patient Population: Estimated 17 million adults diagnosed with MDD in the US annually
• Prescription Trends: Growing preference for sustained-release formulations, driven by ease of compliance and tolerability
• Rebate and Pricing Trends: Pharmaceutical rebates reduce net price; industry average rebates stand near 25-30%
• Regulatory Environment: No recent FDA safety warnings specific to bupropion; patent expirations have historically allowed generic competition, but Forfivo XL retains patent protections in certain jurisdictions

Investment Fundamentals

Revenue Drivers

• Market Penetration: Limited to patients intolerant to other antidepressants due to side effects, which constrains volume
• Pricing Power: Moderate, given brand loyalty and patent protections; generics are available but with limited market share
• Reimbursement Environment: Favorable, with insurance coverage widely available, maintaining consistent demand

Cost Structure and Margins

• R&D costs have declined, with primary expenses related to marketing and sales.
• High gross margins are typical due to the relatively low manufacturing cost of generic active ingredients combined with premium pricing for branded formulations.
• Net margins depend on rebate levels, marketing expenses, and patent enforceability.

Patent and Regulatory Status

• Effective patent protections granted until 2030 in key markets
• No significant threats from biosimilars or generics in the near term
• Ongoing patent litigations may influence exclusivity period

Pipeline and R&D

• Few pipeline assets directly related to Forfivo XL; competing pipelines focus on novel antidepressants, but no significant clinical overlap
• R&D investment has shifted away from existing formulations toward new delivery systems and combination therapies

Competitive Landscape

Product	Manufacturer	Indication	Market Share (Estimated)	Patent Status	Price Point
Forfivo XL	Ajinomoto/Rite Aid	Major depressive disorder	~5% of US depression drug market	Active patents until 2030	~$500/month
Wellbutrin XL	GlaxoSmithKline	Major depression	~50% of bupropion market	Patents expired in 2018	~ $250/month
Generic Bupropion	Various	Major depression	Remaining 45%	Widely available	~$50/month

Investment Risks

• Patent Litigation: Potential patent expiry or invalidation threatens exclusivity
• Market Competition: Rapid adoption of generics can erode premium pricing
• Regulatory Changes: More stringent guidelines could increase compliance costs
• Reimbursement Risks: Changes in insurance policies could impact profitability

Summary and Outlook

Forfivo XL has stable revenue due to patent protections and a niche market focused on patients who cannot tolerate other antidepressants. Its primary value lies in its branded status and patient adherence advantages.

However, market position faces erosion from generics post-patent expiry, with a limited pipeline. The current valuation depends heavily on patent durability and market share retention.

Key Takeaways

• Forfivo XL maintains a niche market with limited direct competition due to patent protections.
• Revenue is driven by patient adherence and branded pricing power.
• Market pressure from generics poses a significant risk post-patent expiration.
• Demand remains steady within targeted patient segments, supported by reimbursement coverage.
• Long-term growth prospects require pipeline development or market expansion strategies.

FAQs

1. What are the main competitors to Forfivo XL?
Wellbutrin XL and generic bupropion formulations are the primary competitors, with generics capturing a large share.

2. How long does patent protection for Forfivo XL last?
Patent protections extend to approximately 2030 in key markets, barring litigation challenges.

3. What are the risks associated with investing in Forfivo XL?
Patent expiration, generic competition, regulatory changes, and reimbursement pressures.

4. How does Forfivo XL’s pricing compare to competitors?
It is priced roughly twice as high as generic bupropion but lower than other branded antidepressants.

5. Is there growth potential for Forfivo XL?
Limited without pipeline expansion or broader indication approvals; growth hinges on maintaining market exclusivity and expanding into new patient segments.

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References

[1] IQVIA. (2023). US Prescription Drug Market Data.
[2] U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Status.
[3] IMS Health. (2022). Market Share and Rebate Data for Antidepressants.