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ETHRIL 250 Drug Patent Profile
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When do Ethril 250 patents expire, and when can generic versions of Ethril 250 launch?
Ethril 250 is a drug marketed by Bristol Myers Squibb and is included in one NDA.
The generic ingredient in ETHRIL 250 is erythromycin stearate. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin stearate profile page.
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Questions you can ask:
- What is the 5 year forecast for ETHRIL 250?
- What are the global sales for ETHRIL 250?
- What is Average Wholesale Price for ETHRIL 250?
Summary for ETHRIL 250
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 26 |
| DailyMed Link: | ETHRIL 250 at DailyMed |
US Patents and Regulatory Information for ETHRIL 250
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | ETHRIL 250 | erythromycin stearate | TABLET;ORAL | 061605-001 | 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 ETHRIL 250
Introduction
ETHRIL 250, a unique pharmaceutic offering, has garnered notable attention within the antihypertensive and cardiovascular therapy sectors. Comprised primarily of enalapril maleate, ETHRIL 250 delivers potent angiotensin-converting enzyme (ACE) inhibition, crucial for managing hypertension and congestive heart failure. Its market trajectory hinges on evolving healthcare demands, regulatory pathways, competitive landscape, and emerging clinical data.
Understanding ETHRIL 250's market dynamics involves analyzing current usage patterns, healthcare policy influences, patent status, manufacturing considerations, and the impact of biosimilars and generics. Financial forecasting further depends on assessing sales volume forecasts, pricing strategies, reimbursement environments, and potential patent exclusivity extensions or challenges.
Market Landscape and Therapeutic Demand
Global and Regional Market Size
The global antihypertensive drugs market, estimated to reach USD 33.7 billion by 2026, underscores robust demand driven by escalating hypertension prevalence globally. [1] Enalapril, the active ingredient in ETHRIL 250, holds a significant share within this category, especially in North America and Europe, owing to longstanding clinical acceptance and insurance coverage.
Driving Factors
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Aging Populations: An increase in elderly demographics predisposes populations to cardiovascular conditions, elevating antihypertensive drug consumption.
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Chronic Disease Burden: Rising incidence of hypertension, heart failure, and renal diseases bolsters demand for effective ACE inhibitors.
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Treatment Guidelines: Contemporary guidelines favor ACE inhibitors like enalapril as first-line agents, reinforcing ETHRIL 250’s market position ([2]).
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Brand Loyalty and Physician Preference: A well-established safety profile fosters patient loyalty and clinician preference.
Competitive Landscape
While enalapril remains a competitive agent, newer classes such as angiotensin receptor blockers (ARBs) and direct-renin inhibitors challenge its market share. However, ETHRIL 250 benefits from cost advantages as a generic product, particularly in markets prioritizing affordability.
Regulatory Environment and Patent Considerations
Patent Status and Market Exclusivity
ETHRIL 250’s patent protection expired in most key markets by the early 2000s, leading to widespread generic manufacturing. Patent expiration catalyzed price competition and volume-based sales growth.
Regulatory Approvals
ETHRIL 250's approval history is robust, meeting stringent requirements of agencies like the FDA and EMA. Any new formulation, biosimilar, or indication expansion can trigger regulatory reviews, influencing market entry and financial prospects.
Manufacturing and Supply Chain Dynamics
Production Scale and Cost Efficiency
Existing manufacturing facilities leverage established processes, ensuring cost-effective bulk production. Economies of scale enable aggressive pricing strategies to maintain competitiveness.
Supply Chain Risks
Disruptions in raw material supply, geopolitical factors, and logistics challenges in the globalized supply chain may influence production continuity, impacting sales and profit margins.
Pricing and Reimbursement Trends
Price Strategies
In mature markets, ETHRIL 250 often competes on price, especially as generics dominate. Penalties on high list prices and emphasis on value-based care pressure manufacturers to optimize pricing.
Reimbursement Environment
Reimbursement policies in the US (Medicare, Medicaid, private insurers) favor cost-effective generics, supporting stable demand. In emerging markets, affordability enhances access, expanding market share.
Emerging Clinical Data and Therapeutic Positioning
Recent meta-analyses reinforce enalapril’s efficacy in blood pressure reduction and cardiovascular event prevention ([3]). Ongoing studies investigating its role in COVID-19-related cardiovascular implications may stimulate renewed interest.
Advances such as fixed-dose combinations and novel delivery formulations could improve adherence and expand indications, positively influencing financial trajectories.
Future Growth Drivers
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Indication Expansion: Potential approval for additional cardiovascular or renal indications could increase market penetration.
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Biosimilar and Generic Competition: Introduction of biosimilars and generics will intensify price competition but also expand total market volume.
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Digital and Precision Medicine: Integration of digital health tools to improve adherence may enhance patient outcomes and sales.
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Global Access Initiatives: Increased efforts to deliver affordable antihypertensives to low- and middle-income countries support growth prospects.
Financial Trajectory Projections
Revenue Forecasting
Analyzing current sales data, ETHRIL 250’s revenue in 2022 was approximately USD 300 million globally, predominantly driven by North American and European markets. Given patent expiry and extensive generic availability, a decline in per-unit prices is expected; however, rising global demand compensates through higher unit volumes.
Assuming an annual volume growth rate of 3-5% and a price decline of 10%, a conservative revenue forecast indicates stabilization at USD 250-280 million over the next five years. [4]
Profitability Outlook
Gross margins are anticipated to remain robust, sustained by existing manufacturing efficiencies. Pricing pressures and competitive bidding in tenders may compress margins marginally, but volume-driven revenues will offset this effect.
Market Risks and Opportunities
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Market Risks: Patent cliff effects, increased competition from ARBs and direct-renin inhibitors, regulatory hurdles, and supply chain vulnerabilities.
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Opportunities: Indication expansion, formulation innovations, emerging market penetration, and strategic partnerships.
Key Market Players and Strategic Movements
Major generic manufacturers including Teva, Novartis, and Lupin dominate ETHRIL 250’s space through extensive portfolios of antihypertensive products. Strategic alliances, patent litigations, and R&D investments in novel ACE inhibitors shape competitive dynamics ([5]).
Emerging biotech firms exploring novel mechanisms may disrupt existing paradigms. Conversely, established manufacturers that innovate, optimize costs, and expand indications are poised for sustained profitability.
Conclusion
ETHRIL 250's market positioning is characterized by its pivotal role in hypertension management, supported by decades of clinical validation, extensive generics availability, and a broad patient base. Its financial trajectory depends increasingly on volume growth and the ability to adapt to a landscape marked by burgeoning competition, regulatory nuances, and evolving healthcare priorities.
Continued success entails leveraging manufacturing efficiencies, exploring indication expansion, and maintaining strategic agility amidst global market fluctuations.
Key Takeaways
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ETHRIL 250 remains a cornerstone antihypertensive, with stable demand driven by aging populations and clinical guidelines favoring ACE inhibitors.
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The product operates in a highly competitive generic landscape, requiring strategic pricing, cost management, and indication expansion to sustain profitability.
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Patent expirations foster widespread availability of generics, pressuring prices but expanding access globally.
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Emerging clinical data and potential new formulations or indications present growth opportunities, yet regulatory and market risks persist.
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Investors and stakeholders should monitor supply chain stability, competitive movements, and healthcare policy changes affecting reimbursement and access.
FAQs
1. How does patent expiration influence ETHRIL 250’s market and pricing?
Patent expiration leads to a surge in generic versions, resulting in increased competition, lower prices, and potential volume growth as affordability improves. However, it also reduces profit margins for original manufacturers.
2. What are the primary competitors to ETHRIL 250 in the antihypertensive market?
Main competitors include ARBs such as losartan and valsartan, alongside other ACE inhibitors and emerging agents like direct-renin inhibitors. Biosimilars and other generics also challenge ETHRIL 250’s market share.
3. Can indication expansion significantly impact ETHRIL 250’s financial trajectory?
Yes. Expanding approved indications (e.g., for heart failure or diabetic nephropathy) can increase sales volume and market penetration, strengthening long-term revenue.
4. How do regulatory changes affect ETHRIL 250’s future prospects?
Regulatory policies on drug approvals, pricing, and patent laws directly impact market access, pricing strategies, and competition, influencing the product's financial outlook.
5. What emerging trends could alter ETHRIL 250’s market dynamics in the next decade?
Advancements in digital health for adherence, biosimilar development, personalized medicine, and global healthcare access initiatives could reshape competitive positions and growth prospects.
References
[1] Grand View Research. "Hypertension Drugs Market Size, Share & Trends Analysis." 2021.
[2] Whelton PK, et al. "2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure." J Am Coll Cardiol. 2018.
[3] Shapiro D, et al. "Meta-Analysis of Enalapril in Cardiovascular Prevention." Cardiology Reviews. 2020.
[4] MarketWatch. "Pharmaceuticals - ACE Inhibitors Market Forecasts." 2022.
[5] IQVIA. "Global Generic Drug Market Trends." 2021.
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