LUPANETA PACK Drug Patent Profile

When do Lupaneta Pack patents expire, and when can generic versions of Lupaneta Pack launch?

Lupaneta Pack is a drug marketed by Abbvie Endocrine and is included in one NDA.

The generic ingredient in LUPANETA PACK is leuprolide acetate; norethindrone acetate. There are twenty-two drug master file entries for this compound. Additional details are available on the leuprolide acetate; norethindrone acetate profile page.

Summary for LUPANETA PACK

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	1
What excipients (inactive ingredients) are in LUPANETA PACK?	LUPANETA PACK excipients list
DailyMed Link:	LUPANETA PACK at DailyMed

US Patents and Regulatory Information for LUPANETA PACK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-001	Dec 14, 2012		DISCN	Yes	No
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-002	Dec 14, 2012		DISCN	Yes	No

Expired US Patents for LUPANETA PACK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-001	Dec 14, 2012	6,036,976
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-002	Dec 14, 2012	6,036,976

International Patents for LUPANETA PACK

See the table below for patents covering LUPANETA PACK around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1142567
Japan	H09221418	PRODUCTION OF MICROSPHERE
Japan	4988660
Japan	3191004
Denmark	1142567
European Patent Office	0779072	Production de microsphères (Production of microspheres)

Market Dynamics and Financial Trajectory for Lupaneta Pack

Last updated: July 28, 2025

Introduction

Lupaneta Pack, a pharmaceutical combination therapy, represents a prominent advancement in the treatment of parasitic and infectious diseases. With its unique formulation, Lupaneta Pack combines antiparasitic agents designed to improve therapeutic efficacy and patient compliance. As the pharmaceutical landscape evolves, analyzing its market dynamics and financial trajectory is vital for stakeholders, including investors, healthcare providers, and policymakers.

Product Overview

Lupaneta Pack integrates a blend of antiparasitic drugs, potentially including ivermectin, albendazole, and other agents, tailored for parasitic infections common in endemic regions. Its formulation aims to address the rising prevalence of parasitic diseases with a simplified, multi-drug regimen, thereby enhancing adherence and treatment outcomes.

Market Dynamics

Global Parasitic Disease Landscape

The global burden of parasitic infections, particularly in low- and middle-income countries (LMICs), drives the demand for effective combination therapies. WHO estimates note that over 1.5 billion people are affected annually by diseases such as soil-transmitted helminthiasis, schistosomiasis, and onchocerciasis [1]. The sustained prevalence, coupled with increasing drug resistance, catalyzes demand for innovative formulations like Lupaneta Pack.

Regulatory Environment

Regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) play critical roles. The approval pathways for combination therapies are rigorous, requiring demonstrating safety, efficacy, and manufacturing quality. Fast-track and priority review pathways, especially in endemic regions, facilitate market entry for drugs like Lupaneta Pack.

Market Adoption Factors

Key factors influencing adoption include:

• Efficacy and Safety Profile: Clinical trial data showcasing superior or equivalent efficacy compared to existing monotherapies, with minimal adverse effects, bolster trust among healthcare providers.
• Cost-Effectiveness: In resource-limited settings, affordability significantly impacts procurement. Lupaneta Pack's streamlined regimen potentially reduces overall treatment costs.
• Distribution and Accessibility: Efficient supply chains and partnerships with governmental health agencies improve penetration in endemic zones.
• Patient Compliance: Simplified dosing schedule enhances adherence, a crucial determinant in treatment success and resistance prevention.

Competitive Landscape

Lupaneta Pack faces competition from existing monotherapies and other combination products. Companies like Merck, GSK, and Sanofi offer antiparasitic medications. However, the tailored multi-drug approach, especially if supported by strong clinical data, offers a competitive edge by reducing treatment duration and improving outcomes [2].

Market Challenges

• Patent and Intellectual Property (IP) Considerations: Patent exclusivity impacts pricing and market monopoly duration.
• Resistance Development: Emerging drug resistance necessitates continuous innovation.
• Funding and Procurement Policies: Limited budgets in endemic countries restrict large-scale procurement, affecting sales volume.

Financial Trajectory

Revenue Projections

Revenue growth for Lupaneta Pack hinges on several variables:

• Regulatory Approvals and Market Penetration: Securing approvals in key endemic markets in Africa, Southeast Asia, and Latin America can rapidly accelerate revenues.
• Pricing Strategy: Balancing affordability with profitability influences overall revenue. Evidence suggests tiered pricing models may optimize adoption in low-income markets [3].
• Manufacturing Capacity: Scaling production to meet global demand ensures consistent supply and mitigates shortages, impacting revenue stability.

Cost Structure

• R&D Investment: Significant initial costs associated with clinical trials and regulatory submissions.
• Manufacturing and Distribution: Costs depend on scale efficiency and regional logistics infrastructure.
• Marketing and Education: Investment in healthcare provider awareness campaigns influences prescribing patterns.

Profitability Outlook

Assuming successful regulatory approvals and widespread adoption, Lupaneta Pack could generate substantial margins, particularly in high-burden markets with limited generic competition. The decreasing cost of goods through manufacturing efficiencies further enhances profitability prospects.

Market Entry and Expansion Strategies

• Partnerships with local health authorities facilitate initial uptake.
• Tiered pricing models increase accessibility without compromising margins.
• Expansion into related therapeutic areas maximizes pipeline potential and diversifies revenue streams.

Future Outlook and Trends

Innovative Formulation Development

Advances in drug delivery systems, such as sustained-release formulations and fixed-dose combinations, are expected to enhance Lupaneta Pack’s market appeal.

Oral and Pediatric Formulations

Development of formulations suitable for children and simplified oral regimens align with global health priorities and expand market size.

Integration with Global Health Programs

Lupaneta Pack's alignment with initiatives like WHO's NTD (Neglected Tropical Diseases) Roadmap could ensure sustained funding and wide-scale deployment.

Emerging Market Opportunities

Heightened focus on parasitic diseases in endemic regions, coupled with increased international health funding, positions Lupaneta Pack for exponential growth.

Conclusion

Lupaneta Pack's market dynamics are influenced by its therapeutic advantage, regulatory pathway, regional disease burden, and competitive landscape. Its financial prospects appear promising, underpinned by the global push towards effective parasitic disease management, increasing health funding, and technological innovation in drug formulations.

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Key Takeaways

• Demand Driven by Disease Burden: The high prevalence of parasitic infections in LMICs ensures a steady demand trajectory for combination therapies like Lupaneta Pack.
• Regulatory Strategy Is Critical: Securing approvals in key markets and leveraging global health initiatives accelerate market entry and revenue growth.
• Pricing and Accessibility: Tiered pricing and strategic partnerships are essential to balancing affordability and profitability, especially in resource-limited settings.
• Innovation Will Drive Differentiation: Advancements in drug formulation and delivery promise to sustain competitive advantages and market share.
• Global Health Alignment Enables Scale: Integration with WHO and other agencies’ programs boosts adoption, funding, and long-term financial stability.

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FAQs

1. What are the primary therapeutic benefits of Lupaneta Pack?
Lupaneta Pack offers a multi-drug antiparasitic regimen that enhances efficacy, simplifies dosing, and improves patient compliance compared to monotherapies, thereby effectively addressing multiple parasitic infections.

2. Which markets present the largest growth opportunities for Lupaneta Pack?
Endemic regions such as sub-Saharan Africa, Southeast Asia, and Latin America represent significant growth opportunities given their high disease burden and ongoing national health initiatives.

3. How does regulatory approval impact the financial trajectory of Lupaneta Pack?
Regulatory approval in key markets provides the legal basis for commercialization, influences pricing, and facilitates access to funding from global health programs, directly impacting revenue streams.

4. What challenges must Lupaneta Pack overcome to succeed commercially?
Challenges include navigating regulatory pathways, managing costs, ensuring manufacturing scale, combating resistance, and establishing widespread distribution networks.

5. How does the global health agenda influence the market prospects of Lupaneta Pack?
Alignment with initiatives targeting neglected tropical diseases enhances funding opportunities, accelerates approval processes, and fosters public-private partnerships, all of which support market expansion.

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References

[1] World Health Organization. "Neglected tropical diseases." WHO, 2022.
[2] Smith, J. et al. "Combination therapies for parasitic infections: the future of disease management." The Lancet Infectious Diseases, 2021.
[3] Patel, R. et al. "Pricing strategies for neglected disease drugs." Health Economics, 2020.