Levonorgestrel - Generic Drug Details

What are the generic drug sources for levonorgestrel and what is the scope of freedom to operate?

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, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co Ltd, Naari Pte Ltd, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, and Sun Pharm, and is included in thirty 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-one suppliers are listed for this compound.

Summary for levonorgestrel

International Patents:	113
US Patents:	7
Tradenames:	14
Applicants:	19
NDAs:	30
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	252
Patent Applications:	6,367
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
Alexion Pharmaceuticals, Inc.	Phase 1
Lori Gawron	Phase 4
Planned Parenthood Association of Utah	Phase 4

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
Naari Pte Ltd	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	207660-001	May 2, 2019		OTC	No	No
Lotus Pharm Co Ltd	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	202684-001	Sep 2, 2016		DISCN	No	No
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990		DISCN	No	No
Bayer Hlthcare	MIRENA	levonorgestrel	SYSTEM;INTRAUTERINE	021225-001	Dec 6, 2000		RX	Yes	Yes	10,561,524
Novast Labs	HER STYLE	levonorgestrel	TABLET;ORAL	207976-001	Mar 11, 2016		OTC	No	No
Xiromed	LEVONORGESTREL	levonorgestrel	TABLET;ORAL	205329-001	Sep 18, 2018		OTC	No	No
Fdn Consumer	PLAN B	levonorgestrel	TABLET;ORAL	021045-002	Aug 24, 2006		DISCN	Yes	No

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
Wyeth Pharms Inc	NORPLANT SYSTEM IN PLASTIC CONTAINER	levonorgestrel	IMPLANT;IMPLANTATION	020088-001	Dec 10, 1990	3,850,911
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990	3,850,911
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016	7,252,839
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013	5,785,053
Population Council	NORPLANT	levonorgestrel	IMPLANT;IMPLANTATION	019897-001	Dec 10, 1990	3,959,322
Bayer Hlthcare	SKYLA	levonorgestrel	SYSTEM;INTRAUTERINE	203159-001	Jan 9, 2013	7,252,839

International Patents for levonorgestrel

Country	Patent Number	Title	Estimated Expiration
Spain	2980154
New Zealand	619783	Intrauterine systems, iud insertion devices, and related methods and kits therefor
Japan	2021518216	子宮内器具（ＩＵＤ）挿入装置および関連する方法とそのためのキット
South Korea	20140051296	INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR
Hong Kong	1155351	AN INSERTER
China	116999234	IUD插入装置和相关方法以及用于其的套件 (IUD INSERTION DEVICES AND RELATED METHODS AND KITS THEREFOR)
Australia	2015221468

Supplementary Protection Certificates for levonorgestrel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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	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	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
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 Levonorgestrel

Introduction to Levonorgestrel

Levonorgestrel is a synthetic progestin widely used in various contraceptive and reproductive health applications, including oral contraceptive pills, intrauterine devices (IUDs), emergency contraceptives, and other hormone-based treatments. Its efficacy and versatility have made it a crucial segment within the global pharmaceutical industry.

Market Size and Growth

The global levonorgestrel market is projected to experience significant growth over the coming years. As of 2023, the market size is valued at approximately USD 7.87 billion and is anticipated to reach USD 11.75 billion by 2033, with a Compound Annual Growth Rate (CAGR) of around 4.2% from 2024 to 2033[3].

In a more specific segment, the levonorgestrel API market was valued at USD 52.01 million in 2023 and is predicted to reach USD 71.37 million by 2031, growing at a CAGR of 4.13% during the forecast period[4].

Key Drivers of the Market

Increasing Demand for Contraceptives

The rising global population and the growing need for family planning services are significant drivers for the levonorgestrel market. The increasing awareness about the importance of family planning and the benefits of contraceptive use have led to a higher demand for levonorgestrel-based products[3].

Expanded Applications

Beyond traditional contraceptive use, levonorgestrel has been approved for the treatment of heavy menstrual bleeding, a condition affecting many women worldwide. This expanded indication has opened up new opportunities for the use of levonorgestrel-based products, driving overall market demand[3].

Innovative Product Developments

The development of innovative levonorgestrel-based products, such as extended-release formulations and combination therapies, is expected to drive market growth. These advancements aim to offer improved convenience, better user experience, and the ability to address diverse needs and preferences[3].

Regional Analysis

North America

North America, particularly the United States, is expected to dominate the global levonorgestrel market. The region's well-established healthcare infrastructure, the availability of diverse contraceptive options, and high awareness about reproductive health contribute to its market leadership[3].

Europe

Europe is another major market for levonorgestrel-based products, with countries such as the United Kingdom, Germany, and France being key contributors. The region's focus on women's healthcare, the availability of subsidized reproductive services, and the growing emphasis on family planning drive the demand for levonorgestrel-based solutions[3].

Asia-Pacific

The Asia-Pacific region is projected to grow rapidly due to the increasing number of women in the population, strong and stringent policies for contraceptive payment, and fertility rates. This growth is driven by the rising healthcare costs and the robust healthcare system in countries like China and India[4].

Competitive Landscape

The levonorgestrel market is characterized by the presence of both large pharmaceutical companies and specialized women's health organizations. Key players include Bayer HealthCare, Qinhuangdao Zizhu Pharmaceutical, Yangzhou Pharmaceutical, Lupin, and Hubei Gedian Humanwell, among others[4].

Market Segmentation

By Type

The levonorgestrel API market is segmented into short-acting contraceptive API and long-acting contraceptive API. The short-acting contraceptive API segment, which includes oral contraceptive pills and injectables, is a major contributor to the market due to its convenience and effectiveness[4].

By Application

The market is segmented into levonorgestrel tablets, mixture products, and hormone-releasing IUDs. The hormone-releasing IUD segment is expected to witness significant growth, particularly in countries like the US, Germany, the UK, China, and India, due to its additional benefits such as alleviating heavy or painful periods[4].

Financial Trajectory

Revenue Projections

The global levonorgestrel market is expected to reach USD 11.75 billion by 2033, with a CAGR of around 4.2% from 2024 to 2033. The levonorgestrel API market is projected to grow from USD 52.01 million in 2023 to USD 71.37 million by 2031, at a CAGR of 4.13% during the forecast period[3][4].

Cost Savings and Economic Impact

The use of levonorgestrel-containing intrauterine systems (LNG-IUS) can result in significant cost savings. For example, in the context of active duty women, the estimated annual cost savings from LNG-IUS use range from $3,387,107 to $47,352,295 with 5% to 25% intrauterine device usage. This highlights the economic benefits of levonorgestrel-based products in reducing unintended pregnancies and associated healthcare costs[5].

Challenges and Restraints

Alternative Contraceptive Methods

The availability of alternative contraceptive methods can act as a restraint for the levonorgestrel market. Consumers may opt for other forms of birth control that offer different benefits or fewer side effects[3].

Potential Side Effects

The potential side effects associated with levonorgestrel use, such as changes in menstrual bleeding, mood changes, and other adverse reactions, can also act as restraints for the market[2].

High-Cost Criteria

The high-cost criteria for the safety and health of levonorgestrel API and the need for significant upfront expenditure for large-scale applications can be major obstacles to industry expansion[4].

Future Outlook

The future outlook for the levonorgestrel market remains positive, driven by the increasing demand for effective and accessible contraceptive options, the development of innovative products, and the integration of digital health technologies. Advancements in product formulations and the use of telemedicine and mobile applications will enhance the accessibility and user experience of levonorgestrel-based products, contributing to the market's steady growth[3].

Key Takeaways

• The global levonorgestrel market is projected to grow significantly, reaching USD 11.75 billion by 2033.
• The levonorgestrel API market is expected to grow from USD 52.01 million in 2023 to USD 71.37 million by 2031.
• Key drivers include increasing demand for contraceptives, expanded applications, and innovative product developments.
• North America and Europe are major markets, with the Asia-Pacific region showing rapid growth.
• The competitive landscape includes large pharmaceutical companies and specialized women's health organizations.
• The market is segmented by type and application, with short-acting contraceptives and hormone-releasing IUDs being significant segments.
• Despite challenges such as alternative contraceptive methods and potential side effects, the market is poised for steady growth.

FAQs

What is the projected market size of the global levonorgestrel market by 2033?

The global levonorgestrel market is anticipated to reach USD 11.75 billion by 2033[3].

What is the CAGR of the levonorgestrel API market from 2024 to 2031?

The levonorgestrel API market is expected to grow at a CAGR of 4.13% from 2024 to 2031[4].

Which region is expected to dominate the global levonorgestrel market?

North America, particularly the United States, is expected to dominate the global levonorgestrel market[3].

What are the key drivers of the levonorgestrel market?

Key drivers include the increasing demand for effective and accessible contraceptive options, the expansion of levonorgestrel's applications, and the development of innovative products[3].

What are the potential restraints for the levonorgestrel market?

Potential restraints include the availability of alternative contraceptive methods and the potential side effects associated with levonorgestrel use[3].

How does the use of levonorgestrel-containing IUDs impact healthcare costs?

The use of levonorgestrel-containing IUDs can result in significant cost savings by reducing unintended pregnancies and associated healthcare costs[5].

Sources

1. Cognitive Market Research: "Global Levonorgestrel Market Report 2024"[1]
2. DrugBank: "Levonorgestrel: Uses, Interactions, Mechanism of Action"[2]
3. DataHorizon Research: "Levonorgestrel Market Size, Share & Forecast 2033"[3]
4. InsightAce Analytic: "Levonorgestrel API Market"[4]
5. PubMed: "Estimated economic impact of the levonorgestrel intrauterine system"[5]

Last updated: 2024-12-16