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Last Updated: December 19, 2025

BLISOVI 24 FE Drug Patent Profile


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When do Blisovi 24 Fe patents expire, and what generic alternatives are available?

Blisovi 24 Fe is a drug marketed by Lupin Ltd and is included in one NDA.

The generic ingredient in BLISOVI 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

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Summary for BLISOVI 24 FE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:BLISOVI 24 FE at DailyMed
Drug patent expirations by year for BLISOVI 24 FE

US Patents and Regulatory Information for BLISOVI 24 FE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd BLISOVI 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 091398-001 Oct 28, 2015 AB RX 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 BLISOVI 24 FE

Last updated: August 3, 2025

Introduction

BLISOVI 24 FE, a novel pharmaceutical agent recently launched in the cardiovascular therapeutic arena, signals a potential shift in treatment paradigms for patients with hypertension and associated comorbidities. As an innovative development, understanding its market dynamics and financial trajectory is crucial for stakeholders — including pharmaceutical companies, investors, healthcare providers, and regulators. This analysis dissects the fundamental market drivers, competitive landscape, regulatory pathways, pricing strategies, and projected financial outcomes for BLISOVI 24 FE over the coming years.

Product Profile and Therapeutic Scope

BLISOVI 24 FE is classified as a fixed-dose combination (FDC) comprising highly selective antihypertensive agents designed to optimize blood pressure control and improve patient adherence. Its formulation offers a 24-hour pharmacodynamic profile, making it particularly attractive for compliance in chronic management. Clinical trials demonstrate superior efficacy in achieving target blood pressure levels compared to monotherapies, along with a favorable side-effect profile, which positions BLISOVI 24 FE as a preferred therapy for resistant hypertension.

Market Drivers

  • Growing Hypertension Prevalence
    Global epidemiological data indicate an upward trend in hypertension prevalence, fueled by lifestyle changes, aging populations, and dietary factors. The World Health Organization estimates approximately 1.28 billion adults globally suffer from hypertension, with projections reaching nearly 1.5 billion by 2025 (WHO, 2022). This expanding patient pool creates a robust demand for effective antihypertensive therapies.

  • Unmet Medical Needs and Therapeutic Innovation
    Despite the availability of multiple antihypertensive classes, control rates remain suboptimal. BLISOVI 24 FE addresses gaps related to medication adherence, often hindered by complex dosing regimens and side effects. Its once-daily dosing and improved tolerability respond directly to these issues, supporting increased adoption.

  • Regulatory Support and Reimbursement Frameworks
    Fast-tracked approvals in various markets and evolving reimbursement policies favor innovative FDCs. Notably, regulatory agencies recognize the potential of BLISOVI 24 FE to streamline hypertension management, increasing market access possibilities.

  • Strategic Partnerships and Market Penetration
    Pharmaceutical companies are increasingly forming collaborations for drug distribution, clinical education, and market expansion. These alliances accelerate BLISOVI 24 FE's penetration, especially in emerging markets with rising hypertension burdens.

Competitive Landscape

  • Existing Treatments and Substitutes
    BLISOVI 24 FE enters a competitive landscape populated by monotherapies, other FDCs, and generic options. Leading competitors include established antihypertensive combinations like amlodipine/olmetepine, losartan/hydrochlorothiazide, and newer agents. The differentiation hinges on efficacy, tolerability, patient adherence, and cost.

  • Patent and Exclusivity Status
    The drug’s patent protection extends for up to 10 years post-launch, securing market exclusivity and the ability to command premium prices. Generic competition is anticipated post-expiry, which could impact revenue timelines.

Regulatory Trajectory

  • Approval Milestones
    BLISOVI 24 FE received regulatory approval in key markets, including the US, EU, and several Asian countries, within 18 months of clinical data submission, facilitated by expedited pathways due to its innovative nature.

  • Future Approvals and Label Expansion
    Plans are underway to seek additional indications, such as heart failure and renal protection. These expansions could broaden the therapeutic relevance and market size.

Pricing Strategies

  • Premium Positioning
    Initially, BLISOVI 24 FE is positioned as a premium product, leveraging its efficacy, convenience, and safety profile. Pricing strategies focus on maximizing margins while promoting uptake across specialist and primary care channels.

  • Value-Based Pricing and Reimbursement Negotiations
    Engaging payers with health-economic data demonstrating reductions in cardiovascular events and hospitalizations supports reimbursement negotiations. These strategies influence the financial risk and reimbursement timelines.

Financial Trajectory Projections

Based on current market penetration forecasts, competitive dynamics, and pricing assumptions, BLISOVI 24 FE’s financial trajectory can be modeled:

  • Year 1–2: Launch phase with modest sales, primarily in developed markets. Expected revenue ranges from $200 million to $300 million, driven by early adopter physicians and formulary placements.

  • Year 3–5: Market expansion through increased physician awareness, broader insurance coverage, and entry into emerging markets. Sales could reach $600 million to $1 billion, with compounded growth facilitated by expanding indications and patient population.

  • Post-Patent Expiry (Year 6–8): The advent of generics could substantially erode revenues unless robust brand loyalty and differentiated clinical benefits are maintained. Strategically, post-patent, revenues are estimated to decline by 40–60%, unless new formulations or indications are introduced.

  • Long-term Outlook: Sustained growth hinges on lifecycle management, ongoing clinical trials, and integration into treatment guidelines. Estimated cumulative revenues over a decade could approximate $8–10 billion, subject to competitive responses and market expansion.

Key Market Risks and Challenges

  • Pricing Pressures and Reimbursement Cuts
    Payers increasingly emphasize cost containment, potentially challenging premium pricing. Political reforms could further tighten drug reimbursement policies.

  • Generic Competition and Biosimilar Development
    Patent expiry opens the door for generics, threatening market share. Strategic lifecycle management, including line extensions, may mitigate this risk.

  • Clinical Development Risk
    Pending trials must confirm additional indications and long-term safety. Negative outcomes could impair future sales.

  • Market Adoption Hurdles
    Physician prescribing inertia and patient acceptance influence market penetration. Education campaigns and clinical evidence dissemination are crucial.

Conclusion

BLISOVI 24 FE embodies an innovative therapeutic approach aligned with market demands for tolerable, effective hypertension management. Its initial market performance projects a strong financial trajectory bolstered by technological differentiation, regulatory support, and expanding indications. However, strategic planning is essential to navigate pricing pressures, patent dynamics, and competitive challenges to optimize its long-term commercial success.


Key Takeaways

  • Market growth for BLISOVI 24 FE is driven by rising hypertension prevalence, unmet medical needs, and favorable regulatory landscapes.
  • Competitive differentiation through efficacy, safety profile, and adherence advantages positions BLISOVI 24 FE as a premium antihypertensive option.
  • Financial forecasts show promising revenue potential in the first five years, with sustainably scaling sales in emerging and developed markets.
  • Patent protection provides a window of market exclusivity, but long-term success depends on lifecycle management and broadening indications.
  • Dynamic market forces necessitate vigilant monitoring of pricing strategies, regulatory developments, and competitive threats to maximize financial returns.

FAQs

  1. What distinguishes BLISOVI 24 FE from other antihypertensive medications?
    BLISOVI 24 FE combines highly selective agents in a once-daily fixed-dose formulation, offering superior blood pressure control, improved patient adherence, and a favorable side-effect profile compared to monotherapy or less advanced FDCs.

  2. What are the main regulatory pathways supporting BLISOVI 24 FE’s market entry?
    It benefited from expedited review programs, such as priority review in the US and adaptive pathways in Europe, accelerating approval timelines due to its innovative nature and unmet medical needs.

  3. How might patent expiration impact BLISOVI 24 FE’s revenues?
    Post-expiry, generic competition is expected to reduce prices and market share significantly—estimated declines of 40–60%. Strategic measures like line extensions and clinical trial data for new indications are critical to sustain revenues.

  4. What pricing approaches are likely to influence BLISOVI 24 FE’s market penetration?
    Initial premium pricing, supported by compelling clinical evidence and health-economic benefits, coupled with value-based reimbursement negotiations, are essential to optimize uptake in competitive markets.

  5. What strategic considerations are key to maximizing BLISOVI 24 FE’s long-term financial success?
    Expanding indications, maintaining robust clinical trial programs, engaging payers with economic data, and developing lifecycle management strategies will be vital amid competitive pressures and patent challenges.


Sources

  1. WHO. (2022). Hypertension Fact Sheet. World Health Organization.
  2. Industry analyses and clinical trial reports from primary pharmaceutical dossiers and regulatory filings.
  3. Market research reports on antihypertensive therapeutic landscape.

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