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Last Updated: December 22, 2024

LEVONORGESTREL Drug Patent Profile


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Which patents cover Levonorgestrel, and what generic alternatives are available?

Levonorgestrel is a drug marketed by Wyeth Pharms Inc, Alvogen, Fdn Consumer, Glenmark Pharms Ltd, L Perrigo Co, Laboratoire Hra, Lotus Pharm Co Ltd, Lupin Ltd, Naari Pte Ltd, Novel Labs Inc, Perrigo R And D, Watson Labs, Xiromed, Amneal Pharms, Barr, Dr Reddys Labs Sa, and Hetero Labs. and is included in forty-six NDAs.

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

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Summary for LEVONORGESTREL
Drug patent expirations by year for LEVONORGESTREL
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Recent Clinical Trials for LEVONORGESTREL

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

SponsorPhase
Alexion Pharmaceuticals, Inc.Phase 1
Lori GawronPhase 4
Planned Parenthood Association of UtahPhase 4

See all LEVONORGESTREL clinical trials

Medical Subject Heading (MeSH) Categories for LEVONORGESTREL

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
Dr Reddys Labs Sa LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 078834-001 May 31, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 091425-001 Jan 18, 2013 AB1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiromed LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 205131-001 Dec 14, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Barr LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 075862-002 Apr 29, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 200248-001 Nov 19, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Sa LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 076625-001 Nov 18, 2004 AB1 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Pharms Inc LEVONORGESTREL levonorgestrel IMPLANT;IMPLANTATION 020627-001 Aug 15, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

LEVONORGESTREL Market Analysis and Financial Projection Experimental

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]

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.