You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 18, 2026

levonorgestrel - Profile


✉ Email this page to a colleague

« Back to Dashboard


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, 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.

Summary for levonorgestrel
International Patents:113
US Patents:7
Tradenames:14
Applicants:20
NDAs:31

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
Population Council JADELLE levonorgestrel IMPLANT;IMPLANTATION 020544-001 Nov 1, 1996 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Pharms Inc LEVONORGESTREL levonorgestrel IMPLANT;IMPLANTATION 020627-001 Aug 15, 1996 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Population Council NORPLANT levonorgestrel IMPLANT;IMPLANTATION 019897-001 Dec 10, 1990 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Pharms Inc NORPLANT SYSTEM IN PLASTIC CONTAINER levonorgestrel IMPLANT;IMPLANTATION 020088-001 Dec 10, 1990 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bayer Hlthcare KYLEENA levonorgestrel SYSTEM;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Bayer Hlthcare KYLEENA levonorgestrel SYSTEM;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bayer Hlthcare KYLEENA levonorgestrel SYSTEM;INTRAUTERINE 208224-001 Sep 16, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for levonorgestrel

International Patents for levonorgestrel

Country Patent Number Title Estimated Expiration
Japan 7392929 ⤷  Get Started Free
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 ⤷  Get Started Free
Portugal 2349143 ⤷  Get Started Free
European Patent Office 1871314 SYSTEME INTRA-UTERIN DETECTABLE PAR ULTRASONS (AN ULTRASONICALLY DETECTABLE INTRAUTERINE SYSTEM) ⤷  Get Started Free
Georgia, Republic of P20166482 ) INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR ⤷  Get Started Free
Mexico 2011002671 ⤷  Get Started Free
Croatia P20130510 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for levonorgestrel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 39/2015 Austria ⤷  Get Started Free 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 122015000093 Germany ⤷  Get Started Free PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 C201630040 Spain ⤷  Get Started Free 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 300814 Netherlands ⤷  Get Started Free PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 132016000025143 Italy ⤷  Get Started Free PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521 15C0050 France ⤷  Get Started Free 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 C 2015 029 Romania ⤷  Get Started Free PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Levonorgestrel: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Levonorgestrel, a synthetic progestogen, is a core component in emergency contraception (EC) and versatile in other reproductive health applications. The drug’s broad adoption, regulatory landscape, and evolving market conditions shape its investment potential. Global demand for contraceptives, government policies, patent expirations, and competition influence levonorgestrel's financial trajectory. Current market size exceeds USD 1.5 billion, with projected CAGR of 5-7% through 2030. Strategic investments hinge on regulatory developments, patent transitions, and expanding use cases, especially in emerging markets.


What is the Market Overview for Levonorgestrel?

Global Market Size & Growth

Parameter Figures & Trends Sources
2022 Global Market Size USD 1.52 billion [1]
Estimated CAGR (2023-2030) 5-7% [2]
Major Revenue Regions North America, Europe, Asia-Pacific [3]

Market Segments

Segment Description Market Share (2022) Growth Drivers
Emergency Contraception Tablets, intrauterine devices 65% Unintended pregnancy prevention
Reproductive Health Contraceptive pills, intrauterine systems 25% Family planning, population control
Off-Label Uses Heavy menstrual bleeding, others 10% Expanded therapeutic applications

Key Market Players

Company Market Share Focus Areas Notable Developments
Bayer AG 30% EC, LARC New formulations
Watson Pharmaceuticals 20% Oral pills Patent expirations
Teva Pharmaceutical 15% Generic levonorgestrel Competitive pricing
Others 35% Diversified Regional expansion

What are the Market Dynamics Affecting Levonorgestrel?

Key Drivers

  • Rising Unintended Pregnancy Rates: Estimated 89 million unintended pregnancies annually globally, fueling demand for EC [4].

  • Increasing Acceptance of Contraceptives: Social and policy shifts promote reproductive autonomy, increasing use of levonorgestrel-based products [5].

  • Regulatory Approvals & Reimbursement Policies: Easier access, over-the-counter availability in many countries, supports growth [6].

  • Emerging Markets Penetration: Expanding healthcare infrastructure and awareness in Asia, Africa, and Latin America drive volume [7].

Challenges & Constraints

  • Patent Expiry & Generic Competition: Patent expiration for key formulations in 2025 in major markets may erode margins [8].

  • Regulatory Barriers: Strict approval processes and reimbursement policies can delay market entry.

  • Alternative Technologies: Advances in long-acting reversible contraceptives (LARCs), such as subdermal implants, threaten market share.

  • Pricing & Affordability: Cost sensitivity in emerging markets limits growth opportunities.

Competitive Landscape & Innovation

  • Product Differentiation: Development of combination pills, lower-dose formulations, extended-release options.

  • Regulatory Approvals: Recent approvals for new delivery formats (e.g., intravaginal rings) could open new markets.

  • Market Entry Barriers: Patent barriers and manufacturing scale requirements influence competitive strategies.


What is the Financial Trajectory for Levonorgestrel?

Projection Assumptions

  • Market Penetration: Continued growth in emerging markets and expanding indications.

  • Pricing Trends: Slight declines due to generic competition, offset by volume increases.

  • Regulatory Landscape: No significant new restrictions; potential for accelerated approvals.

Revenue Forecast (2023-2030)

Year Estimated Market Size (USD billion) Projected Revenue (USD billion) Notes
2023 1.60 1.55 Recovery post-pandemic
2025 1.75 1.70 Patent expiry impacts margins
2027 2.00 1.90 Generic competition stabilizes
2030 2.30 2.15 Market maturation

Profitability & Investment Trends

Attribute Details
Gross Margins 40-55% depending on market segment and formulation
R&D Investment Approximately 8-12% of revenue for new formulations, delivery methods
M&A Activity Focused on portfolio expansion and pipeline acquisition

Risk Factors

  • Competitive pricing pressures
  • Regulatory delays and restrictions
  • Supply chain disruptions
  • Changes in global reproductive health policies

How Do Patent Expirations Shape Investment Opportunities?

Patent Expiry Year Impact Strategic Actions
2025 Generic entries increase competition, reduce prices Investment in innovation, new delivery systems
2030 Possible secondary patents or exclusivity periods Focus on formulation differentiation

Patent Landscape Summary

Patent Type Duration Recent Trends Implication
Composition of Matter 20 years Expired in key jurisdictions by 2025 Increased generic entries
Delivery Systems & Formulations 15-17 years Ongoing filings New market opportunities

Comparison with Other Contraceptive Drugs

Drug Active Ingredient Market Size (2022) Key Markets Patent Status CAGR
Levonorgestrel Synthetic progestogen USD 1.52B Global Expiring 2025 5-7%
Ulipristal Acetate Selective progesterone receptor modulator USD 300M US, Europe Patent expired 4-6%
Combined Oral Contraceptives Ethinylestradiol + progestins USD 4.2B Global Multiple patents 3-5%

Conclusion: Investment Outlook for Levonorgestrel

Levonorgestrel’s market remains resilient amid rapid demographic shifts and evolving reproductive health needs. Its dominant position in emergency contraception and steady expansion into other indications support a stable financial trajectory, with projected revenues reaching approximately USD 2.15 billion by 2030. However, patent expirations in 2025, increased generic competition, and the emergence of novel contraceptive modalities present challenges. Strategic investments should focus on innovation, pipeline expansion, and expanding access in emerging markets.


Key Takeaways

  • The global levonorgestrel market is valued at USD 1.52 billion (2022), with a CAGR of 5-7% anticipated through 2030.
  • Emergency contraception accounts for the majority of revenues, with expanding use in reproductive health.
  • Patent expirations in key markets can erode margins, necessitating innovation and formulation differentiation.
  • Increasing market share in emerging economies offers significant growth opportunities.
  • Competitive pressures and regulatory hurdles highlight the importance of strategic R&D and diversification.

FAQs

1. How will patent expirations in 2025 affect levonorgestrel’s market?
Patent expirations will lead to a surge in generic formulations, intensifying competition and reducing prices. Companies investing in new delivery systems or combination products can mitigate revenue losses.

2. What emerging markets show the most promise for levonorgestrel expansion?
Regions such as Southeast Asia, Sub-Saharan Africa, and Latin America demonstrate high growth potential due to increasing awareness, evolving policies favoring contraceptive access, and improving healthcare infrastructure.

3. Are there new formulations or delivery systems for levonorgestrel in development?
Yes, innovations include extended-release intrauterine devices, intravaginal rings, and combination pills with other contraceptives—aimed at improving compliance and expanding market share.

4. How does competition from newer contraceptive methods impact levonorgestrel?
While LARCs and hormonal implants dominate long-term contraception, levonorgestrel remains vital for emergency contraception and short-term use, maintaining its niche.

5. What strategic moves should investors consider regarding levonorgestrel?
Investors should monitor patent timelines, R&D pipelines, regulatory changes, and emerging markets, diversifying portfolios with companies focusing on innovation and geographic expansion.


References

[1] MarketWatch. (2022). Levonorgestrel Market Size and Trends.
[2] Grand View Research. (2023). Contraceptive Market Forecast.
[3] IQVIA. (2022). Global Contraceptive Market Insights.
[4] UNFPA. (2021). Adolescent Pregnancy and Family Planning.
[5] WHO. (2022). Reproductive Rights and Access.
[6] FDA. (2022). Over-the-Counter Contraceptive Approvals.
[7] Bain & Company. (2021). Emerging Market Healthcare.
[8] PatentScope. (2022). Levonorgestrel Patent Landscape.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.