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Last Updated: December 12, 2025

LOW-OGESTREL-28 Drug Patent Profile


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Which patents cover Low-ogestrel-28, and when can generic versions of Low-ogestrel-28 launch?

Low-ogestrel-28 is a drug marketed by Dr Reddys Labs Sa and is included in one NDA.

The generic ingredient in LOW-OGESTREL-28 is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.

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Summary for LOW-OGESTREL-28
Drug patent expirations by year for LOW-OGESTREL-28

US Patents and Regulatory Information for LOW-OGESTREL-28

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa LOW-OGESTREL-28 ethinyl estradiol; norgestrel TABLET;ORAL-28 075288-002 Jul 28, 1999 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 LOW-OGESTREL-28

Last updated: July 28, 2025

Introduction

LOW-OGESTREL-28, a combined oral contraceptive containing ethinylestradiol and desogestrel, occupies a significant segment within the global contraceptive landscape. Its market trajectory is influenced by evolving regulatory environments, demographic trends, technological advancements, and shifting consumer preferences. This analysis delineates the drivers shaping LOW-OGESTREL-28’s market dynamics, forecasts its financial trajectory, and explores strategic implications for stakeholders across the pharmaceutical value chain.

Market Overview

The global contraceptive market, projected to reach USD 24.5 billion by 2026 (CAGR approximately 6.2%), encompasses a diverse portfolio of products including oral contraceptives, injectables, implants, intrauterine devices (IUDs), and barrier methods. Among these, oral contraceptives like LOW-OGESTREL-28 contribute substantially, particularly in North America, Europe, and emerging markets across Asia and Africa.

Market Position of LOW-OGESTREL-28:
As a monophasic combined oral contraceptive (COC), LOW-OGESTREL-28 offers high efficacy, convenience, and safety—factors favoring its continued adoption. Its formulation aligns with guidelines promoted by leading health authorities such as WHO and CDC, positioning it favorably within the contraceptive market.

Market Drivers

1. Growing Global Demand for Family Planning

Increasing awareness and acceptance of family planning—driven by rising literacy rates, urbanization, and government initiatives—spur demand for reliable contraceptives. The United Nations reports that approximately 1.1 billion women globally require contraception, with unmet needs estimated at 190 million (UNFPA, 2021). This creates an expanding market for products like LOW-OGESTREL-28.

2. Regulatory Approvals and Policy Support

Regulatory agencies such as the FDA, EMA, and WHO endorse oral contraceptives, facilitating their market accessibility. Government policies promoting reproductive health further incentivize pharmaceutical companies to maintain and expand their contraceptive portfolio involving LOW-OGESTREL-28. Novel application approvals and generics in emerging markets are driving revenue growth.

3. Advancements in Formulation and Delivery

Innovations such as reduced pill size, simplified packaging, and fixed-dose combination improvements enhance user adherence. These technological advances bolster LOW-OGESTREL-28’s appeal, potentially increasing market share.

4. Growing Female Empowerment and Workforce Participation

Enhanced focus on women’s rights correlates with increased contraceptive use, especially among working women seeking family planning options compatible with active lifestyles. The rising acceptance of oral contraceptives facilitates continued demand for established products like LOW-OGESTREL-28.

5. Market Expansion in Emerging Economies

Regions such as India, Southeast Asia, and Sub-Saharan Africa experience rapid demographic growth and increased healthcare spending. WHO reports rising contraceptive prevalence rates in these markets, with oral contraceptives seen as affordable, convenient options. Regulatory approvals and local manufacturing partnerships further accelerate this trend.

Market Constraints and Challenges

1. Competition from Alternatives

Long-acting reversible contraceptives (LARCs), including implants and IUDs, are gaining popularity due to higher efficacy and reduced compliance dependence. Additionally, non-hormonal and natural methods are gaining traction among specific user segments.

2. Concerns Over Side Effects and Safety Profiles

Potential adverse effects—such as thromboembolic events associated with estrogen component—may influence consumer choice and regulatory scrutiny. Misinformation and side effect fears can dampen uptake.

3. Patent Expirations and Generic Market Entry

Generic versions of LOW-OGESTREL-28 threaten to erode profit margins. Patent expirations in certain jurisdictions catalyze price competition, compelling manufacturers to innovate or diversify their offerings.

4. Regulatory and Cultural Barriers

In conservative markets, cultural resistance and regulatory constraints hinder contraceptive dissemination. Legal restrictions on contraceptive advertising and usage further limit market penetration.

Financial Trajectory Projections

Revenue Projections

Based on current market trends, LOW-OGESTREL-28’s global sales are expected to grow at a CAGR of 4-6% over the next five years. Key contributing factors include increasing demand in emerging markets, new regulatory approvals, and enhanced product lifecycle management strategies.

Pricing and Market Share Dynamics

While premium pricing persists in mature markets, intense competition from generics compresses margins. Strategic alliances with local manufacturers and patent litigations influence pricing strategies. In growth markets, affordability remains vital; thus, tiered pricing and volume-based sales are anticipated.

Impact of Patent Expirations

Patent expirations in developed markets around 2025-2027 could lead to a significant influx of generics, substantially reducing revenues unless innovative formulations or extensions are introduced. Companies are proactively investing in next-generation contraceptives or combination therapies to maintain market relevance.

Investment and Growth Strategies

Pharmaceutical companies are channeling investments into R&D for novel contraceptive formulations, including non-hormonal options and multi-purpose products integrating contraception with other health benefits (e.g., STI prevention). Strategic marketing campaigns and digital engagement also aim to bolster market traction.

Strategic Implications

  • Portfolio Diversification: Companies should balance legacy products like LOW-OGESTREL-28 with innovation to offset generic competition.
  • Market Expansion: Tailored strategies are essential for emerging markets—local manufacturing, culturally sensitive marketing, and pricing flexibility.
  • Regulatory Navigation: Proactive engagement with health authorities ensures smoother approval pathways and compliance.

Conclusion

LOW-OGESTREL-28 remains a vital product within the global contraceptive ecosystem, supported by demographic trends, regulatory approvals, and technological improvements. Its financial trajectory hinges on strategic adaptation to market forces—particularly competition, patent landscapes, and regional opportunities. Continuous innovation and targeted growth strategies are paramount for sustained profitability.


Key Takeaways

  • The global contraceptive market is expanding, with LOW-OGESTREL-28 poised for steady growth driven by demographic and socio-cultural shifts.
  • Competition from LARCs and generics necessitates innovation and strategic positioning.
  • Emerging markets represent pivotal growth corridors, requiring tailored marketing and regulatory strategies.
  • Patent expirations highlight the importance of pipeline innovation to sustain revenue.
  • Investment in next-generation contraceptives and digital marketing will significantly influence profitability trajectories.

FAQs

1. How does LOW-OGESTREL-28 compare to other oral contraceptives in terms of efficacy and side effects?
LOW-OGESTREL-28 offers comparable efficacy to other combined oral contraceptives with a favorable safety profile. Side effects are similar, primarily including nausea, headache, and rare thromboembolic events, aligning with general contraceptive risk patterns.

2. What are the key regulatory hurdles for LOW-OGESTREL-28 in emerging markets?
Regulatory hurdles include varying approval timelines, compliance with local standards, and cultural restrictions. Engaging with local regulators early and adapting formulations to regional requirements are critical for market entry.

3. How does patent expiration impact LOW-OGESTREL-28’s market share and revenue?
Patent expiration opens markets to generic competitors, reducing prices and margins. Companies must innovate ahead of expirations, such as developing next-generation products or expanding into new indications.

4. What role do technological advancements play in enhancing LOW-OGESTREL-28’s marketability?
Advancements like improved formulations, single-dose packaging, and digital adherence tools improve user experience, adherence, and ultimately, market share.

5. What are future growth prospects for LOW-OGESTREL-28 within the broader contraceptive market?
The product’s prospects remain robust given demographic trends, especially in emerging markets. Strategic diversification, innovation, and consolidation will underpin continued growth amidst competitive pressures.


Sources:
[1] UNFPA. (2021). World Contraceptive Use.
[2] MarketWatch. (2022). Global Contraceptive Market Report.
[3] WHO. (2022). Family Planning/Contraceptive Methods.

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