PREVEN EMERGENCY CONTRACEPTIVE KIT Drug Patent Profile

When do Preven Emergency Contraceptive Kit patents expire, and what generic alternatives are available?

Preven Emergency Contraceptive Kit is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in PREVEN EMERGENCY CONTRACEPTIVE KIT is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for PREVEN EMERGENCY CONTRACEPTIVE KIT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	518
DailyMed Link:	PREVEN EMERGENCY CONTRACEPTIVE KIT at DailyMed

US Patents and Regulatory Information for PREVEN EMERGENCY CONTRACEPTIVE KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	PREVEN EMERGENCY CONTRACEPTIVE KIT	ethinyl estradiol; levonorgestrel	TABLET;ORAL	020946-001	Sep 1, 1998		DISCN	No	No

Expired US Patents for PREVEN EMERGENCY CONTRACEPTIVE KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	PREVEN EMERGENCY CONTRACEPTIVE KIT	ethinyl estradiol; levonorgestrel	TABLET;ORAL	020946-001	Sep 1, 1998	6,156,742

International Patents for PREVEN EMERGENCY CONTRACEPTIVE KIT

See the table below for patents covering PREVEN EMERGENCY CONTRACEPTIVE KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2558297
European Patent Office	0904084
Japan	2000511890

Supplementary Protection Certificates for PREVEN EMERGENCY CONTRACEPTIVE KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for PREVEN Emergency Contraceptive Kit

Last updated: August 5, 2025

Introduction

The pharmaceutical landscape surrounding emergency contraception has experienced substantial shifts driven by regulatory, societal, and technological factors. Among key players, PREVEN Emergency Contraceptive Kit has carved out a significant position, influenced by evolving consumer needs and healthcare policies. This analysis explores the market dynamics shaping PREVEN’s trajectory and projects its financial outlook amid competitive pressures and expanding markets.

Market Overview

The global emergency contraceptive market has grown at a compounded annual growth rate (CAGR) of approximately 9.2% from 2018 to 2022, driven by increased awareness, shifts in socio-cultural attitudes, and improved regulatory access [1]. The demand for OTC (over-the-counter) options remains robust, with the Preferring method being oral pills such as PREVEN, which offers a user-friendly alternative to more invasive procedures.

The increasing incidence of unplanned pregnancies worldwide—estimated at nearly 60% of pregnancies globally—amplifies the need for accessible emergency contraceptives [2]. Regulatory agencies, like the FDA in the United States, have liberalized access to such medications, further propelling market expansion.

PREVEN’s positioning as a safe, effective, and easy-to-use oral emergency contraceptive aligns well with this market trend. Its formulations, typically consisting of levonorgestrel, are recognized for their efficacy when administered within 72 hours of unprotected intercourse, which sustains broad consumer appeal.

Key Market Drivers

1. Regulatory Approvals and Over-the-Counter Access

Recent regulatory decisions have played an integral role in expanding PREVEN’s market share. The FDA’s approval for OTC sale of levonorgestrel-based emergency contraceptives has significantly lowered barriers for consumer access, correspondingly increasing sales [3].

Similarly, regulatory bodies in Europe and Asia are easing restrictions, fostering potential market penetration in emerging economies with high unplanned pregnancy rates.

2. Societal and Cultural Shifts

Public awareness campaigns, especially targeting youth and women of reproductive age, have heightened consciousness regarding reproductive rights and emergency contraception options. The reduction of stigma associated with emergency contraception fosters higher consumption, bolstering demand for products like PREVEN.

3. Technological Advancements

Innovations in formulation and delivery mechanisms, including combination therapies and improved packaging, have improved efficacy, usability, and shelf life—further boosting consumer confidence and adherence.

4. Competitive Landscape

While generic options dominate, branded formulations—including PREVEN—distinguish themselves through brand recognition, distribution channels, and perceived efficacy. Such advantages underpin their ability to maintain market share despite intense generic competition.

5. Global Expansion

Emerging markets account for a growing share of sales, fueled by demographic shifts and increased healthcare infrastructure. Companies investing in localized manufacturing and partnerships are set to exploit this expansion efficiently.

Market Challenges

Despite robust growth prospects, PREVEN and similar products face distinct challenges:

• Regulatory Variance: Differing approval statuses across countries create complex compliance landscapes.
• Consumer Awareness: In some regions, limited awareness or cultural resistance hampers widespread adoption.
• Pricing Pressures: Intense competition from lower-cost generics constrains margins.
• Legal and Ethical Debates: Ongoing debates may influence policy decisions, impacting access and sales.

Financial Trajectory

Revenue Projections

Based on current market data and growth drivers, the global emergency contraceptive market is projected to reach approximately USD 1.2 billion by 2025, reflecting a CAGR of 8.8% between 2022 and 2025 [1].

PREVEN's market share is anticipated to grow at a slightly higher rate contingent on successful regulatory approvals and marketing strategies. Assuming a conservative market share increase from 8% to 12% over the forecast period, PREVEN's revenues could approximate USD 144 million by 2025, up from an estimated USD 80 million in 2022.

Profitability Considerations

Margins are influenced by manufacturing costs, distribution, and competitive pricing strategies. Given the product’s relatively low-cost formulation, gross margins may hover around 50%, with net margins affected by marketing and regulatory compliance expenses.

Scaling manufacturing capacity and establishing strong distribution alliances can yield economies of scale, further improving profitability. Moreover, direct-to-consumer marketing campaigns and digital health initiatives will be pivotal in strengthening brand loyalty and expanding consumer base.

Investment and R&D

Investments in formulation innovation, packaging, and digital platforms are strategic priorities. Enhanced formulations, such as single-dose options with increased bioavailability, can command higher prices and loyalty.

Additionally, expanding indications—such as prophylactic use or combination therapies—present future revenue avenues, contingent on regulatory approval.

Competitive Landscape and Strategic Positioning

PREVEN’s primary competitors include generic levonorgestrel pills and other branded brands like Plan B One-Step and Ella. While generics dominate due to cost advantages, brand products leverage consumer trust, efficacy perception, and marketing.

To sustain competitive advantage, PREVEN can:

• Strengthen regional partnerships.
• Expand into untapped markets through tailored regulatory strategies.
• Invest in consumer education campaigns.
• Innovate formulations for enhanced efficacy and convenience.

Regulatory and Policy Impact

Policy shifts favoring OTC availability are paramount. Countries implementing dedicated reproductive health policies can catalyze sales growth. Conversely, tightening regulations or ideological opposition could impede market expansion.

Proactive engagement with policymakers and advocacy groups is essential to mitigate risks and align product offerings with societal values.

Conclusion

The PREVEN Emergency Contraceptive Kit stands at a strategic intersection of market growth drivers and challenges. Its financial trajectory hinges on regulatory navigation, competitive positioning, and consumer awareness. With targeted investments and strategic market expansion, PREVEN is poised for sustained growth in a dynamic global landscape.

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Key Takeaways

• The emergency contraceptive market is experiencing consistent growth driven by regulatory liberalization, societal acceptance, and demographic shifts.
• PREVEN’s strategic advantage relies on regulatory approvals, brand recognition, and expanding consumer base, especially in emerging markets.
• Market projections suggest revenues could reach approximately USD 144 million by 2025, assuming increased market share and geographic expansion.
• Competitive differentiation through formulation innovation and regional partnerships is vital to sustain profitability amid pricing pressures.
• Engagement with policymakers and ongoing innovation will be crucial for navigating legal and societal challenges impacting market access.

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FAQs

1. How does regulatory approval influence PREVEN’s market prospects?
Regulatory approvals, especially for OTC sales, expand consumer access, directly enhancing sales volumes. Favorable policies accelerate market penetration and revenue growth, while restrictive regulations pose significant barriers.

2. What trends are shaping consumer demand for emergency contraception?
Increased awareness, reduced stigma, and accessibility initiatives drive demand. Additionally, the integration of digital health platforms for education and purchase facilitates broader adoption.

3. How does PREVEN differentiate from generic competitors?
PREVEN capitalizes on brand trust, perceived efficacy, and packaging standards. Strategic marketing and regional partnerships bolster its competitive edge against low-cost generics.

4. What are key opportunities for PREVEN’s expansion?
Emerging markets with high unmet demand, regulatory reforms, and product innovation present significant growth avenues. Tailored marketing in culturally sensitive regions enhances market penetration.

5. What are main risks impacting the financial trajectory?
Regulatory reversals, sociopolitical controversies, and pricing pressures from generics could dampen growth. Investing in consumer education and advocacy mitigates these risks.

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Sources:
[1] Market Research Future, "Emergency Contraceptive Market," 2022.
[2] World Health Organization, "Unplanned Pregnancy Data," 2021.
[3] U.S. Food and Drug Administration, "OTC Labeling for Levonorgestrel," 2019.