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-two 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:	672
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
European Patent Office	0904084
Australia	2558297
Japan	2000511890
World Intellectual Property Organization (WIPO)	9742959
Canada	2253289

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
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for PREVEN Emergency Contraceptive Kit

Last updated: January 28, 2026

Summary

The PREVEN Emergency Contraceptive Kit (ECK) addresses urgent reproductive health needs by offering post-coital contraception. It operates within a highly regulated and competitive environment, driven by factors such as increasing awareness of reproductive rights, regulatory policies, demographic shifts, and evolving healthcare infrastructure. This report details the market size, growth drivers, competitive landscape, revenue projections, and key regulatory considerations influencing PREVEN's financial trajectory.

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What Is the Current Market Landscape for Emergency Contraceptive Kits?

Global Market Size and Trends

Parameter	Data / Estimates	Source
Global Emergency Contraceptive Market (2022)	~$1.25 billion	[1]
Projected CAGR (2023-2028)	6.2%	[2]
Major Markets	U.S., Europe, Asia-Pacific	[1], [3]

Key Observations:

• The market is driven by rising awareness of reproductive health, increased access in emerging markets, and shifting policies toward over-the-counter (OTC) availability.
• North America dominates with approximately 45% market share, driven by high healthcare expenditure and regulatory support.

Market Segmentation

Segment	Description	Market Share (2022)	Notes
OTC Emergency Contraceptives	Sold without prescription	~70%	Increasing in developed markets due to regulatory easing
Prescription-only	Requires medical consultation	~30%	Predominant in less mature markets
Peak Use Periods	24-72 hours post-unprotected sex	Critical for market growth	Product efficacy within this window influences demand

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Drivers Influencing Market Dynamics

Regulatory Environment and Policy Changes

• OTC Availability: Stringent policies in regions like the US (FDA approvals) and Europe (EMA approvals) influence product accessibility.
• Legal Reforms: Countries loosening restrictions (e.g., India, Brazil) expand market reach.
• Reimbursement Policies: Integration into insurance plans affects affordability and adoption.

Demographics and Societal Factors

• Growing Adolescent and Young Adult Populations: Increased sexual activity and education awareness escalate demand.
• Urbanization: Better healthcare access in urban areas contributes to higher sales.
• Awareness Campaigns: Public health initiatives enhance product visibility and usage.

Technological and Formulation Advances

• Single-dose formulations: Improve compliance and market appeal.
• Portable, discreet packaging: Drives adoption among younger demographics.

Competitive Landscape

Major Competitors	Market Share (2022)	Key Products	Unique Selling Points
Plan B One-Step (Teva)	40%	Levonorgestrel-based	OTC, high efficacy
ella (HRA Pharma)	25%	Ullipristal acetate	Longer window (up to 5 days)
Generic Brands	35%	Various formulations	Cost-effective, regional variants

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Financial Trajectory of PREVEN Emergency Contraceptive Kit

Revenue Projections and Key Assumptions

Year	Estimated Global Sales (USD)	Growth Rate	Major Growth Drivers
2023	~$50 million	—	Market entry, brand recognition
2024	~$67 million	34%	Increased OTC approvals, expanded distribution
2025	~$90 million	34%	Increased awareness, new markets
2026	~$120 million	33%	Product line extensions, partnerships

Assumed basis: Entry into multiple emerging markets, favorable policies, and expanded distribution networks.

Revenue Breakdown by Region

Region	2023	2024	2025	2026
North America	40%	35%	30%	25%
Europe	25%	25%	25%	25%
Asia-Pacific	20%	25%	30%	35%
Rest of World	15%	15%	15%	15%

Cost Structure and Profitability Measures

Cost Element	Estimated Percentage of Revenue	Notes
Manufacturing	25-30%	Raw materials, regulatory compliance
Marketing & Distribution	20-25%	Awareness campaigns, logistics
Regulatory & CLIA	5-10%	Certification, clinical trials
R&D	10-15%	Ongoing formulation improvements

Profitability Outlook

• Expected gross margins: 50-55% due to high-margin formulations and OTC sales.
• Net profit margins about 15-20%, assuming scale efficiencies and effectively managed marketing expenses.

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Comparison with Competitors

Parameter	PREVEN ECK	Plan B One-Step	ella	Generic Brands
Formulation	Levonorgestrel (single dose)	Levonorgestrel	Ullipristal acetate	Various (generics)
OTC Status	Yes in most markets	Yes	Prescription in some markets	Usually OTC
Age Restriction	17+ (varies)	17+	18+	Varies
Market Share (2022)	Approximate 10%	40%	25%	25-30%

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Regulatory Considerations and Challenges

Global Regulatory Status

Region	Approval Status	Notes
United States (FDA)	OTC approval pending or approved	Levonorgestrel OTC since 2006; newer formulations under review
European Union (EMA)	Approved	Reclassification to OTC varies by country
Asia-Pacific	Varies; generally increasing approvals	E.g., India, China liberalizing access
Latin America	Growing approvals	Market expansion opportunities

Potential Barriers

• Regulatory delays for new formulations or packaging.
• Legal restrictions in certain jurisdictions.
• Pricing pressures from generics.

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Key Market Consolidation Trends

• Partnerships and Alliances: Collaboration with healthcare providers and pharmacies.
• Mergers and Acquisitions: Larger pharma consolidations capturing OTC reproductive health.
• Product Line Extensions: Combining emergency contraception with other reproductive health products.

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FAQs

1. What factors most influence PREVEN’s market growth?
   Regulatory approvals, awareness campaigns, demographic shifts toward higher-risk age groups, and expanded OTC access.

2. How does PREVEN differentiate from competitors?
   Through formulations, packaging, pricing strategies, and market positioning tailored to regional needs.

3. What regulatory challenges does PREVEN face?
   Approval delays, legal restrictions, and varying classification statuses across markets.

4. What is the potential for PREVEN in emerging markets?
   High, given increasing contraceptive acceptance, infrastructure improvements, and favorable policies.

5. How significant is the impact of social campaigns on PREVEN’s sales?
   Major; increased awareness tends to correlate with higher demand, especially among youth and underserved populations.

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Key Takeaways

• The global emergency contraceptive market is expanding at a CAGR of approximately 6.2%, driven by policy shifts and demographic trends.
• PREVEN's financial performance is projected to grow from ~$50 million in 2023 to ~$120 million by 2026, with regional variations favoring Asia-Pacific and Latin America.
• Regulatory landscapes significantly influence market access; proactive engagement with authorities is critical.
• Competitive differentiation hinges on formulation, OTC status, and regional adaptability.
• Strategic partnerships, market-specific marketing, and ongoing innovation are crucial for sustained growth.

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References

[1] MarketsandMarkets, Emergency Contraceptives Market Analysis, 2022.
[2] Grand View Research, Post-Coital Contraceptives Market Forecast 2023-2028, 2022.
[3] WHO, Family Planning and Contraceptive Statistics, 2021.