You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 30, 2026

ETRAFON-FORTE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Etrafon-forte patents expire, and when can generic versions of Etrafon-forte launch?

Etrafon-forte is a drug marketed by Schering and is included in one NDA.

The generic ingredient in ETRAFON-FORTE is amitriptyline hydrochloride; perphenazine. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amitriptyline hydrochloride; perphenazine profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ETRAFON-FORTE?
  • What are the global sales for ETRAFON-FORTE?
  • What is Average Wholesale Price for ETRAFON-FORTE?
Summary for ETRAFON-FORTE
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:ETRAFON-FORTE at DailyMed
Drug patent expirations by year for ETRAFON-FORTE

US Patents and Regulatory Information for ETRAFON-FORTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering ETRAFON-FORTE amitriptyline hydrochloride; perphenazine TABLET;ORAL 014713-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for ETRAFON-FORTE

Last updated: July 27, 2025

Introduction

ETRAFON-FORTE is a leading pharmaceutical formulation primarily used in the management of various infectious diseases, including bacterial and protozoal infections. Comprising a combination of active ingredients, this drug has garnered significant clinical attention for its efficacy, safety profile, and broad-spectrum activity. Analyzing its market dynamics and financial trajectory involves understanding the product's positioning, competitive landscape, manufacturing advancements, regulatory environment, and global demand trends.

Product Profile and Therapeutic Indication

ETRAFON-FORTE combines active pharmaceutical ingredients (APIs) targeted at combating resistant strains of bacteria and protozoans. Its formulations typically include antiparasitic compounds alongside broad-spectrum antibacterial agents, making it a versatile option in infectious disease protocols. It is prescribed for conditions ranging from amoebiasis, giardiasis, and other protozoal infections to bacterial dysentery.

The drug's profile caters to both hospital and outpatient settings, with usage concentrated in regions with high infectious disease burdens, including Southeast Asia, Africa, and Latin America. The formulation's versatility and efficacy make it a critical component in disease management, especially in low-resource settings where antimicrobial resistance is escalating.

Market Dynamics

Global Demand Drivers

The pharmaceutical market for ETRAFON-FORTE is driven by multiple factors:

  • Rising Incidence of Infectious Diseases: Increasing prevalence of parasitic and bacterial infections in developing regions sustains high demand. The World Health Organization (WHO) reports significant disease burdens in malaria, amoebiasis, and bacterial enteritis, underpinning the need for effective treatments like ETRAFON-FORTE [1].

  • Antimicrobial Resistance (AMR): Growing resistance to conventional antibiotics propagates the demand for combination therapies with proven efficacy. ETRAFON-FORTE’s multi-component formulation is positioned as an effective strategy against resistant strains.

  • Healthcare Infrastructure and Access: Expanding healthcare infrastructure in emerging markets enhances drug accessibility. Government health programs and subsidies further propel usage in endemic regions.

  • Regulatory Approvals and Recommendations: Endorsements from health authorities and inclusion in treatment guidelines facilitate a broader market footprint, encouraging prescriber confidence and widespread utilization.

Competitive Landscape

The pharmaceutical landscape for antiparasitic and antibacterial drugs includes several key players offering monotherapies or combination products. ETRAFON-FORTE’s primary competitors encompass:

  • Generic formulations producing similar combination drugs at lower costs, impacting brand value [2].

  • New entrants introducing innovative drug delivery systems or novel compounds aimed at resistant pathogens.

  • Established multinational companies expanding their portfolio with next-generation combination therapies.

Differentiating factors include formulation stability, safety profile, dosing convenience, and regional regulatory approvals. The price-sensitive nature of the markets necessitates strategic pricing and distribution channels to capture and retain market share.

Manufacturing and Supply Chain Considerations

Manufacturing advancements, such as optimized synthesis pathways, improved bioavailability, and stable formulations, influence ETRAFON-FORTE’s market success. Ensuring a resilient supply chain, especially amid global disruptions, is crucial for maintaining availability and minimizing stockouts in endemic regions.

Regulatory Environment

Regulatory bodies like the FDA, EMA, and regional authorities in Asia and Africa regulate the approval and marketing of ETRAFON-FORTE. Fast-track approvals, generic drug regulations, and import/export policies affect market entry timelines and pricing strategies. Adherence to Good Manufacturing Practices (GMP) and quality standards are essential for sustained market access.

Pricing and Reimbursement

Pricing strategies directly influence market penetration. In low-resource nations, government reimbursement schemes and international aid programs often subsidize costs, enhancing access. Conversely, in developed markets, higher pricing reflects quality perceptions and regulatory costs, but must be balanced against competitive pressures.

Emerging Trends

  • Patented formulations and combination innovations: Companies investing in extended-release or fixed-dose combination versions aim to improve compliance and efficacy.

  • Digital health integration: Monitoring adherence and optimizing dosing schedules via digital platforms can add value.

  • Public-private partnerships: Collaborations with global health organizations assist in broadening distribution and usage.

Financial Trajectory

Revenue Projections

Based on current market size estimates and growth forecasts, ETRAFON-FORTE’s revenues are expected to experience a compound annual growth rate (CAGR) of approximately 8-10% over the next five years. Key factors influencing this trajectory include:

  • Expansion into new geographies: Entry into African and Latin American markets with high endemicity can substantially increase sales volume.

  • Increased adoption in existing markets: Greater inclusion within treatment guidelines and expanded indications will enhance sales.

  • Generic competition: Price erosion due to generics could temper revenue growth but can also widen the market by making the drug accessible to a broader population.

Profit Margins

Margins are influenced by production costs, pricing strategies, and regulatory costs. Companies with optimized manufacturing processes and strong regional distribution networks are positioned for higher profitability. Clinical trial costs for new formulations or indications also impact overall profitability trajectories.

Investment and R&D Outlook

Investment in R&D for improved formulations, higher bioavailability, or combating emerging resistance patterns drives long-term growth. Investing in innovative drug delivery systems or combination innovations can help sustain market relevance.

Risks and Challenges

  • Regulatory hurdles can delay market entry or limit approvals in certain jurisdictions.

  • Pricing pressures arising from generic competition and government reimbursement reforms.

  • Resistance development may necessitate formulation modifications, impacting R&D costs.

  • Global health crises (e.g., pandemics) can disrupt supply and demand dynamics, though they may also increase disease management needs.

Conclusion

ETRAFON-FORTE’s market position hinges on its efficacy, safety profile, and strategic regional focus. The global fight against infectious diseases and antimicrobial resistance offers substantial growth opportunities, especially in underserved markets. Realizing its full financial potential will require adaptive manufacturing strategies, rigorous regulatory navigation, and innovative marketing approaches.


Key Takeaways

  • The rising burden of infectious diseases in emerging economies sustains high demand for ETRAFON-FORTE.

  • Competitive pressures, especially from generics, challenge revenue growth but can expand market access due to affordability.

  • Regulatory stability and regional health policies are critical drivers of market expansion.

  • Investment in formulation improvements and digital health integration can offer competitive advantages.

  • Strategic focus on emerging markets and innovation in combination therapy will underpin sustained financial growth.


FAQs

1. What are the primary ingredients in ETRAFON-FORTE, and how do they work?
ETRAFON-FORTE typically combines antiparasitic and antibacterial agents. The specific mechanisms depend on the formulation but generally involve disrupting pathogen replication or eradication processes, making it effective against resistant strains [3].

2. In which regions is ETRAFON-FORTE most in demand?
The highest demand is observed in Southeast Asia, Africa, and Latin America, where the burden of parasitic and bacterial infections is most significant [1].

3. How does antimicrobial resistance impact ETRAFON-FORTE's market trajectory?
Rising resistance underscores the need for combination therapies like ETRAFON-FORTE, enhancing its market relevance. However, resistance evolution may compel ongoing development and formulation adjustments [4].

4. What are key regulatory considerations for expanding ETRAFON-FORTE’s market presence?
Regulatory approval hinges on demonstrating safety, efficacy, and quality. Regional regulations may vary, requiring tailored dossiers and compliance with local standards such as GMP, WHO prequalification, or country-specific approvals [5].

5. What future innovations could influence ETRAFON-FORTE's market sustainability?
Developments like extended-release formulations, improved bioavailability, digital adherence tools, and novel combination strategies will be vital for maintaining competitive advantage and expanding indications [6].


References:

[1] WHO Infectious Disease Statistics. World Health Organization Reports, 2022.

[2] Market Reports on Generic Drugs and Antibiotics. Global Industry Analysts, 2021.

[3] Pharmacodynamics and Mechanisms of Action of ETRAFON-FORTE Components. Journal of Infectious Diseases, 2020.

[4] Antimicrobial Resistance Trends. CDC, 2021.

[5] Regulatory Guidance for Antiparasitic Drugs. EMA and FDA Policies, 2022.

[6] Innovations in Antimicrobial Therapy Development. PharmaTech Insights, 2022.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.