LEVONORGESTREL - Generic Drug Details

What are the generic sources for levonorgestrel and what is the scope of patent protection?

Levonorgestrel is the generic ingredient in fourteen branded drugs marketed by Population Council, Wyeth Pharms Inc, Bayer Hlthcare, Medicines360, Aurobindo Pharma, Lupin Ltd, Novast Labs, Alvogen, Annora Pharma, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co Ltd, Naari Pte, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, and Sun Pharm, and is included in thirty-one NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levonorgestrel has one hundred and thirteen patent family members in thirty-five countries.

There are twenty drug master file entries for levonorgestrel. Thirty-four suppliers are listed for this compound.

Summary for LEVONORGESTREL

International Patents:	113
US Patents:	7
Tradenames:	14
Applicants:	20
NDAs:	31
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	277
Patent Applications:	6,624
Drug Prices:	Drug price trends for LEVONORGESTREL
What excipients (inactive ingredients) are in LEVONORGESTREL?	LEVONORGESTREL excipients list
DailyMed Link:	LEVONORGESTREL at DailyMed

See drug prices for LEVONORGESTREL

See drug sales revenues for LEVONORGESTREL

Recent Clinical Trials for LEVONORGESTREL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Premier Research	PHASE2
University of Florida	PHASE2
Pfizer	PHASE1

See all LEVONORGESTREL clinical trials

Pharmacology for LEVONORGESTREL

Drug Class	Progestin Progestin-containing Intrauterine System Progestin-containing Intrauterine Device
Physiological Effect	Inhibit Ovum Fertilization

Medical Subject Heading (MeSH) Categories for LEVONORGESTREL

Contraceptive Agents, Female

Contraceptives, Oral, Synthetic

Anatomical Therapeutic Chemical (ATC) Classes for LEVONORGESTREL

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03AD	Emergency contraceptives
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for LEVONORGESTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novast Labs	HER STYLE	levonorgestrel	TABLET;ORAL	207976-001	Mar 11, 2016		OTC	No	No
Xiromed	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202740-001	Sep 2, 2016		DISCN	No	No
Naari Pte	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202380-001	May 29, 2015		OTC	No	No
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013		RX	Yes	Yes	11,628,088		Y

Expired US Patents for LEVONORGESTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MIRENA	levonorgestrel	SYSTEM;INTRAUTERINE	021225-001	Dec 6, 2000	5,785,053
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990	3,850,911
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013	5,785,053
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016	7,252,839

International Patents for LEVONORGESTREL

Country	Patent Number	Title	Estimated Expiration
Brazil	112020019403
Canada	2735952
Croatia	P20181826
Brazil	PI0919228

Supplementary Protection Certificates for LEVONORGESTREL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
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
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

Market Dynamics and Financial Trajectory for Levonorgestrel

Last updated: July 28, 2025

Introduction

Levonorgestrel, a synthetic progestogen widely used as an emergency contraceptive and in various hormonal contraceptive formulations, remains a pivotal player in the reproductive health market. Its long-standing efficacy, safety profile, and regulatory approval across global markets underpin its commercial stability. Analyzing the market dynamics and financial prospects requires understanding clinical advancements, regulatory trends, competitive landscape, and evolving consumer preferences.

Historical and Current Market Overview

Levonorgestrel's introduction in the 1980s revolutionized reproductive health, particularly with over-the-counter (OTC) availability for emergency contraception. According to IQVIA data, the global contraceptive market, valued approximately at USD 20 billion in 2022, includes a significant share attributed to levonorgestrel-based products. Its sales are driven by high consumer demand for reliable, accessible contraception options.

Market Drivers

Multiple factors fuel levonorgestrel's market trajectory:

1. Rising Awareness of Reproductive Rights: Increased education and advocacy have led to greater acceptance of hormonal contraception, boosting demand globally. Governments and NGOs actively promote contraceptive access, further expanding the market [1].

2. Regulatory Approvals and Market Expansion: Many countries have relaxed restrictions on OTC sales of levonorgestrel-based emergency contraceptives, notably in North America, Europe, and parts of Asia. This regulatory shift enhances sales volume and accessibility [2].

3. Product Diversification: Pharmaceutical companies are innovating formulations—combining levonorgestrel with other agents or developing new delivery systems such as intrauterine devices (IUDs)—which sustains growth prospects.

4. Demographic Trends: Population growth, especially among reproductive-age women in emerging markets like India and Nigeria, expands the consumer base, unlocking growth opportunities.

Market Challenges and Constraints

Despite its strengths, several challenges impede exponential growth:

• Competitive Landscape: Introduction of newer emergency contraceptives such as ulipristal acetate and ellaOne provides alternatives, intensifying market competition [3].

• Pricing and Reimbursement Policies: In many jurisdictions, pricing negotiations and insurance reimbursement policies influence patient access, potentially limiting market expansion.

• Cultural and Legal Barriers: Variability in cultural acceptance and restrictive legal environments in certain countries hinder universal access.

• Patent and Intellectual Property Dynamics: Patent expirations can prompt generic entry, reducing prices but also impacting revenue streams for innovator companies.

Emerging Trends Influencing Market Trajectory

1. Shift Toward Long-Acting Reversible Contraceptives (LARCs): While LARCs dominate the contraceptive market with higher efficacy and compliance, levonorgestrel-based oral pills continue to be preferred for immediate, on-demand contraception.

2. Digital Health Integration: Mobile app-based reminders and telemedicine consultations are improving adherence and awareness, indirectly supporting levonorgestrel sales.

3. Growing Demand in Low- and Middle-Income Countries (LMICs): Efforts by NGOs and governments to improve contraceptive access are aligning with levonorgestrel's affordability and efficacy, driving sustained growth in these regions.

Financial Trajectory and Revenue Outlook

Forecasts indicate a steady growth trajectory for levonorgestrel-based products:

• Market Size Projections: The global emergency contraceptive market alone is expected to reach approximately USD 2.2 billion by 2030, growing at a CAGR of 8–10% (2023–2030) [4]. Levonorgestrel remains a dominant active ingredient within this segment.

• Revenue Streams: Established brands like Plan B One-Step and its generics contribute significantly to revenues, with strategic launches of new formulations further expanding income streams.

• Impact of Patent Expirations: The patent expirations of some formulations in the late 2010s partially opened the floodgates for generic competition, intensifying price pressure but also broadening market penetration.

• Emerging Markets: Rapid population growth and rising healthcare infrastructure investments in LMICs are expected to amplify revenues over the next decade.

Competitive Landscape

Major pharmaceutical players like Teva, Pfizer, and Noor Abu Dhabi Pharma dominate the landscape, leveraging their extensive distribution networks. The entrance of biosimilar and generic manufacturers in emerging markets enhances affordability and access, albeit compressing margins for established brands.

Regulatory and Policy Influences

Government policies significantly influence market trajectories:

• OTC Accessibility: Countries like the U.S., UK, and Canada have expanded OTC access, directly boosting sales.

• Reimbursement Models: Variations across countries can either limit or promote product utilization—public health initiatives often subsidize costs in LMICs, promoting broader usage.

• Legal Restrictions: Legislation surrounding contraception rights, especially in conservative regions, creates regional disparities in market potential.

Future Outlook

Long-term prospects for levonorgestrel are robust, driven by demographic trends, policy shifts favoring access, and product innovation. However, success hinges on navigating regulatory landscapes, maintaining product differentiation, and aligning with evolving consumer preferences.

Key Market Segments and Revenue Drivers

• Emergency Contraception: The largest segment, forecasted to grow at a CAGR of 8–10%, driven by OTC accessibility and consumer awareness.

• Oral Contraceptives: Adjunct use of levonorgestrel in daily pills continues, with innovations targeting improved compliance.

• Intrauterine Devices (IUDs): Levonorgestrel-releasing IUDs constitute a growing subset, offering long-term solutions with high efficacy, expanding the product portfolio.

Implications for Stakeholders

• Pharmaceutical Companies: Continued investment in formulation improvements, market expansion strategies, and real-world evidence collection can sustain growth.

• Regulatory Agencies: Streamlining approval processes and expanding OTC access will influence market dynamics favorably.

• Investors: Focusing on company pipelines, especially in emerging markets and generic manufacturing, offers lucrative opportunities given the stable, yet growing, revenue landscape.

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Key Takeaways

• Levonorgestrel's extensive clinical history and regulatory acceptance underpin its continued dominance in reproductive health.

• Market expansion hinges on improved access, particularly through OTC availability and in LMICs.

• Competition from newer contraceptive agents and generics exerts pricing pressure but also broadens consumer options.

• Innovations such as long-acting delivery systems and digital health integration will shape future growth.

• Strategic positioning by pharmaceutical firms around emerging markets and regulatory trends can enhance long-term revenue prospects.

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FAQs

1. How does patent expiration impact levonorgestrel market revenues?
Patent expirations of branded levonorgestrel formulations open markets to generic manufacturers, significantly reducing product prices and eroding revenue margins for originators. However, increased competition can boost overall market volume and accessibility, especially in regions with price-sensitive consumers.

2. What are the main regulatory hurdles for levonorgestrel in expanding markets?
Regulatory challenges include approval delays, restrictions on OTC sales, and legal restrictions related to reproductive rights. Variations in regulatory frameworks across countries require tailored compliance strategies for market entry.

3. How is technological innovation influencing levonorgestrel formulations?
Innovations include the development of long-acting intrauterine devices! and novel delivery systems that improve efficacy, compliance, and user convenience, thereby expanding market segments and enhancing revenue potential.

4. What role do demographic trends play in levonorgestrel’s market outlook?
Demographic factors such as increasing reproductive-age populations, especially in LMICs, drive demand. Population growth coupled with rising awareness and improved healthcare infrastructure sustains long-term growth prospects.

5. How do competitive dynamics shape future revenue streams?
The rise of generic manufacturers and alternative contraceptive methods intensifies price competition, potentially compressing margins but also expanding market access and consumer choice, ultimately fostering a resilient revenue environment for leading players aligned with market needs.

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References

[1] IQVIA. Global contraceptive market report, 2022.
[2] U.S. Food and Drug Administration. Emergency contraceptives regulations overview, 2023.
[3] European Medicines Agency. Approvals and updates on emergency contraception, 2022.
[4] Grand View Research. Emergency Contraceptive Market Size, Share & Trends, 2023-2030.