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ORTHO-NOVUM 1/50 21 Drug Patent Profile
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When do Ortho-novum 1/50 21 patents expire, and when can generic versions of Ortho-novum 1/50 21 launch?
Ortho-novum 1/50 21 is a drug marketed by Ortho Mcneil Pharm and is included in one NDA.
The generic ingredient in ORTHO-NOVUM 1/50 21 is mestranol; norethindrone. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethindrone profile page.
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Questions you can ask:
- What is the 5 year forecast for ORTHO-NOVUM 1/50 21?
- What are the global sales for ORTHO-NOVUM 1/50 21?
- What is Average Wholesale Price for ORTHO-NOVUM 1/50 21?
Summary for ORTHO-NOVUM 1/50 21
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Patent Applications: | 57 |
| DailyMed Link: | ORTHO-NOVUM 1/50 21 at DailyMed |
US Patents and Regulatory Information for ORTHO-NOVUM 1/50 21
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ortho Mcneil Pharm | ORTHO-NOVUM 1/50 21 | mestranol; norethindrone | TABLET;ORAL-21 | 012728-004 | 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 |
rket Dynamics and Financial Trajectory for ORTHO-NOVUM 1/50 21
Introduction
ORTHO-NOVUM 1/50 21, a combined oral contraceptive (COC), remains a prominent product within the global reproductive health market. Its market dynamics are driven by evolving demographic trends, regulatory landscapes, competitive alternatives, and shifting consumer preferences. Understanding the financial trajectory of ORTHO-NOVUM 1/50 21 involves analyzing these factors alongside broader pharmaceutical industry trends and patent/patent-expiration impacts. This report provides a detailed, authoritative assessment of its current market position and future financial prospects.
Product Overview and Market Position
ORTHO-NOVUM 1/50 21, manufactured by a leading pharmaceutical entity, contains a low-dose combination of ethinyl estradiol and norethindrone, designed for contraception. It has a well-established reputation for efficacy, safety, and user compliance. Currently, it is marketed globally, with significant penetration in North America, Europe, and parts of Asia-Pacific.
Despite competitive pressures from newer formulations—such as drospirenone-based pills, extended-cycle pills, and non-hormonal methods—ORTHO-NOVUM 1/50 21 maintains substantial market share due to brand loyalty, physician prescribing habits, and familiarity.
Market Dynamics
Demographic Trends and Consumer Preferences
The global contraceptive market is projected to reach USD 23 billion by 2027, growing at a CAGR of approximately 6% (source: Fortune Business Insights). The increasing awareness of reproductive health, early sexual activity, and urbanization in emerging markets fuel demand for reliable contraceptives.
In developed countries, however, growth is tempered by declining birth rates and increased use of long-acting reversible contraceptives (LARCs). Conversely, emerging markets exhibit robust growth potential. In particular, India, China, and Africa represent expanding horizons owing to rising female workforce participation and expanding healthcare infrastructures.
Key Point: The demographic shift and evolving consumer preferences towards oral pills, perceived as convenient and familiar, sustain demand for products like ORTHO-NOVUM 1/50 21.
Regulatory Environment and Patent Landscape
The patent expiry landscape significantly influences market dynamics. ORTHO-NOVUM 1/50 21's original patent expired approximately a decade ago, inviting generic competitors. Generics capture a substantial portion of market share, with pharmaceutical companies now relying on brand differentiation, patent protections on new formulations, or marketing strategies to maintain revenue.
Regulatory bodies such as the FDA (United States), EMA (Europe), and regulators in emerging markets enforce strict safety and efficacy standards. Recent trends include approval of low-dose formulations, which have impacted sales figures for traditional formulations like ORTHO-NOVUM.
Key Point: Patent expirations have resulted in increased generic competition, necessitating strategic innovation and differentiation.
Competitive Landscape
The market is fragmented but dominated by a few key players, including Bayer, Pfizer, and Teva. Generics now account for a lion’s share of contraceptive sales globally, compelling branded products to innovate with extended-release formulations or combination strategies.
New entrants focus on non-hormonal methods and digital health integrations, intensifying competition. For ORTHO-NOVUM 1/50 21, maintaining market share hinges on prescriber loyalty and consumer preference for established brands.
Pricing and Reimbursement Dynamics
Pricing policies are crucial; in developed markets, coverage by insurance plans and government reimbursement schemes influence sales volume. In emerging markets, affordability remains a primary driver, with generic availability impacting price competitiveness.
Pharmaceutical companies use tiered pricing strategies to navigate diverse economic landscapes, which affect the overall revenue trajectory of ORTHO-NOVUM 1/50 21.
Financial Trajectory Analysis
Current Revenue and Market Share
While specific revenue figures are proprietary, industry estimates suggest that traditional oral contraceptive products generate between USD 2-4 billion annually globally. ORTHO-NOVUM 1/50 21, being a leading brand, commands a significant share—estimated at approximately 10-15% within its segment.
Factors influencing current revenues include:
- Market Penetration: Deep penetration in established markets.
- Generic Competition: High, leading to price competition.
- Product Lifecycle Stage: Mature, with stable but plateauing revenues.
Forecasted Growth and Trends
The trajectory for ORTHO-NOVUM 1/50 21 is characterized by plateauing sales in mature markets but potential growth in emerging economies. Projected revenue CAGR is expected to be modest, around 1-3% over the next five years, driven by:
- Expansion into emerging markets.
- Prescriber inertia in developed regions.
- Potential reformulation or combination ventures leveraging existing brand recognition.
Impact of Patent Policies and Innovation
The expiration of key patents has precipitated a surge in generics, compressing profit margins. However, investments in research may enable new formulation launches, such as fixed-dose combinations, extended-cycle pills, or non-hormonal contraceptives, providing revenue uplift.
Financial Risks and Opportunities
Risks: Regulatory hurdles, patent litigations, declining consumer preferences for established products, and commoditization due to generics threaten financial stability.
Opportunities: Digital health integration, personalized contraception, and entry into untapped markets could positively influence financial results.
Global Market and Geographical Outlook
In North America and Europe, the mature markets prefer long-acting reversible contraceptives, constraining growth prospects for traditional pills like ORTHO-NOVUM 1/50 21. Nonetheless, healthcare provider inertia and patient familiarity sustain sales.
Emerging markets—particularly in Asia, Africa, and Latin America—present growth opportunities, fueled by rising contraceptive awareness and government initiatives supporting family planning. Local manufacturing and strategic partnerships are crucial for penetrating these markets.
Regulatory and Legal Impact on Financials
Regulatory agencies’ approval processes influence product lifecycle and revenue timelines. Recent moves advocating for lower-dose formulations, improved safety profiles, and non-hormonal options may impact market share and innovation pathways for legacy products.
Legal challenges, including patent disputes and regulatory compliance costs, can influence profitability and strategic planning.
Conclusion and Future Outlook
The financial trajectory of ORTHO-NOVUM 1/50 21 is predominantly mature, with steady revenues in established markets and growth opportunities in developing regions. Its sustained market presence depends on maintaining prescriber loyalty, navigating patent expirations, and evolving consumer preferences.
The product’s future hinges on strategic innovation—such as new formulations and digital health approaches—and strategic expansion into high-growth geographies. The integrating of non-hormonal contraceptive options presents a potential avenue for revitalizing the brand’s market share.
Key Takeaways
- Market Stability and Challenges: ORTHO-NOVUM 1/50 21 remains a stable player, though faced with significant generic competition and shifting consumer preferences towards long-acting and non-hormonal methods.
- Emerging Market Catalysts: Growth potential in Asia-Pacific, Africa, and Latin America driven by demographic trends and healthcare infrastructure development.
- Innovation Risks and Opportunities: Patent expirations necessitate innovation; digital and personalized contraception represent promising avenues.
- Pricing and Reimbursement Impact: Successful navigation of diverse reimbursement landscapes will be critical for maintaining revenue streams.
- Strategic Positioning: Continued investment in marketing, education, and market expansion essential for sustaining profitability and competitive relevance.
FAQs
1. How does patent expiry affect the financial future of ORTHO-NOVUM 1/50 21?
Patent expiry typically leads to increased generic competition, reducing prices and profit margins. However, it also opens avenues for increased market share through affordable generics, provided the original manufacturer sustains brand loyalty.
2. What are the primary growth opportunities for this contraceptive product?
Expansion in emerging markets and product innovation—such as new formulations, extended cycles, or combinations—offer significant growth avenues, especially where contraceptive awareness and healthcare access are improving.
3. How does consumer preference shift impact the product’s market?
A move toward long-acting reversible contraceptives (LARCs), non-hormonal options, and digital health solutions challenges the traditional oral contraceptive segment, necessitating strategic adaptation by brands like ORTHO-NOVUM 1/50 21.
4. What role does healthcare provider loyalty play in the product’s financial performance?
Prescriber inertia and familiarity significantly influence continued prescription of established brands. Maintaining relationships with healthcare providers and demonstrating safety/effectiveness are key for sustaining sales.
5. How might regulatory changes influence the product’s future revenue?
Regulatory shifts favoring safer, lower-dose, or non-hormonal options could diminish market share for traditional formulations unless companies innovate or adapt quickly.
References
[1] Fortune Business Insights. "Contraceptive Market Size, Share & Industry Analysis." 2022.
[2] IQVIA. "Global Pharmaceutical Market Data," 2022.
[3] European Medicines Agency. "Contraceptive Drugs Regulatory Framework," 2021.
[4] Deloitte. "Pharmaceutical Industry Outlook 2023," 2023.
[5] Statista. "Global Birth Control Market Forecast," 2022.
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