ella Drug Patent Profile

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

Ella is a drug marketed by Lab Hra Pharma and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-five patent family members in twenty-eight countries.

The generic ingredient in ELLA is ulipristal acetate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ulipristal acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Ella

Ella was eligible for patent challenges on August 13, 2014.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ella

International Patents:	65
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	70
Patent Applications:	1,041
Drug Prices:	Drug price information for ella
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ella
What excipients (inactive ingredients) are in ella?	ella excipients list
DailyMed Link:	ella at DailyMed

See drug prices for ella

Pharmacology for ella

Drug Class	Progesterone Agonist/Antagonist
Mechanism of Action	Selective Progesterone Receptor Modulators

Paragraph IV (Patent) Challenges for ELLA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELLA	Tablets	ulipristal acetate	30 mg	022474	1	2014-08-13

US Patents and Regulatory Information for ella

ella is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	8,426,392
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	9,844,510		Y
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	10,159,681
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	8,512,745		Y
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	8,962,603
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	9,283,233
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	8,735,380		Y

EU/EMA Drug Approvals for ella

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Laboratoire HRA Pharma	ellaOne	ulipristal acetate	EMEA/H/C/001027Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.	Authorised	no	no	no	2009-05-15
Gedeon Richter Plc.	Ulipristal Acetate Gedeon Richter	ulipristal acetate	EMEA/H/C/005017Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.	Withdrawn	no	no	no	2018-08-27

International Patents for ella

When does loss-of-exclusivity occur for ella?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Russian Federation

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ella around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2757496
Japan	2016188232	オンデマンド避妊方法 (METHOD FOR ON-DEMAND CONTRACEPTION)
Japan	5951480
Ukraine	101863	ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА;ТАБЛЕТКИ НА ОСНОВІ УЛІПРИСТАЛУ АЦЕТАТУ (ULIPRISTAL ACETATE TABLETS)
Montenegro	02548	POSTUPAK ZA KONTRACEPCIJU PO POTREBI (METHOD FOR ON-DEMAND CONTRACEPTION)
San Marino	T201600399
Colombia	6400186

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ELLA

Last updated: July 27, 2025

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Introduction

ELLA (generic name: ulipristal acetate) has become a prominent player within the emergency contraception market, representing a critical advancement in reproductive health. As a selective progesterone receptor modulator (SPRM), ELLA offers a highly effective, prescription-based alternative to over-the-counter emergency contraceptives. This analysis explores the market dynamics shaping ELLA's trajectory, examines its revenue potentials, competitive positioning, regulatory landscape, and future growth prospects, providing key insights for stakeholders and industry observers.

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Market Landscape and Segmentation

Global Emergency Contraception Market Overview

The global emergency contraception (EC) market has experienced consistent growth, driven by rising awareness, shifting social attitudes toward reproductive health, and increased access to healthcare services. The market was valued at approximately USD 3.2 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of around 6.2% through 2030 (Grand View Research, 2022). ELLA, as a prescription-only LNG-EC, occupies a distinct niche within this landscape, primarily serving informed consumers seeking a more effective and reliable option than OTC pills like levonorgestrel.

Segmentation Dynamics

• Product Type: Prescription drugs (ELLA) versus OTC formulations (levonorgestrel-based).
• Distribution Channels: Hospitals, clinics, pharmacies, online pharmacies.
• End Users: Healthcare providers, women aged 15–45, policymakers focusing on reproductive health.

ELLA's positioning as a prescription-based therapy accentuates its role among healthcare practitioners, emphasizing the importance of medical oversight to optimize efficacy and manage side effects.

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Regulatory and Patent Framework

Regulatory Status and Approvals

ELLA received regulatory approval from the European Medicines Agency (EMA) in 2011 for the treatment of heavy menstrual bleeding, and later in various jurisdictions for emergency contraception (e.g., Europe, Canada, Australia, and select Asian markets). Notably, EMA approved ELLA specifically for emergency contraception in 2015 [1].

Patent Landscape

Ulipristal acetate's patent protection historically limited generic competition. The original patent expiration in the European Union occurred around 2018–2020, opening avenues for generic entries, which could impact ELLA's market share and pricing in the coming years. Patent expirations tend to exert downward pressure on prices, influencing revenue streams.

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Competitive Dynamics

Key Competitors

• Levonorgestrel Pills: OTC, widely accessible, lower cost, but slightly less effective (89% efficacy versus 95% with ELLA).
• Ulipristal Acetate (Brand: ellaOne): The flagship prescription ELLA, offering higher efficacy and a broader window of use (up to 120 hours post-coitus).

Emerging Competitive Threats

The entrance of generics post-patent expiry, combined with advances in novel emergency contraceptives or non-hormonal alternatives, could alter the competitive landscape. Additionally, ongoing research into long-acting reversible contraceptives (LARCs) and non-hormonal options may influence overall market demand.

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Market Dynamics Influencing ELLA’s Trajectory

1. Increasing Awareness and Education

Global campaigns addressing reproductive rights and contraceptive options have expanded awareness about the importance of effective emergency contraception. Healthcare provider endorsement and patient education programs are pivotal in increasing ELLA's prescription rates, especially in regions where cultural factors previously limited access.

2. Accessibility and Prescribing Policies

In several markets, regulatory constraints prevent OTC sales of ulipristal acetate, maintaining ELLA's prescription-only status. This limits immediate access but ensures medical oversight, which could appeal to healthcare-conscious consumers but restrict rapid uptake in regions emphasizing self-care.

3. Pricing and Reimbursement Policies

Pricing strategies significantly impact ELLA's adoption:

• In developed markets: Reimbursement schemes and insurance coverage facilitate broader access.
• In emerging markets: Price elasticity and limited healthcare insurance coverage can hinder market penetration of premium-priced drugs like ELLA.

4. Patent Expiry and Generic Competition

Post-2020, generic ulipristal acetate products are expected to enter markets, exerting downward pressure on ELLA’s price point and margins. While this enhances consumer access, original manufacturers face revenue compression, requiring strategic adaptation.

5. Regulatory Approvals and Expansions

Expanding approved indications (e.g., treatment of heavy menstrual bleeding) and geographic expansion into underserved markets (Africa, Southeast Asia) could boost revenues. Regulatory hurdles, especially in countries with conservative reproductive health policies, remain significant barriers.

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Financial Trajectory Projections

Revenue Drivers

• Market Penetration: Increasing prescription volumes driven by education campaigns and physician endorsement.
• Pricing Strategies: Premium pricing maintained in markets with limited generics, with anticipated erosion post-patent expiry.
• Geographic Expansion: Growth in emerging markets, where contraceptive awareness is increasing.
• Indication Expansion: Additional approved uses, such as heavy menstrual bleeding, provide multiple revenue streams.

Financial Forecasts (2023–2030)

• Revenue Growth: Predicted CAGR of 4–6% over the next decade, tempered by generic penetration.
• Margins: Initially high margins due to brand recognition; expected decline as generic competition intensifies.
• Market Share: Steady in developed markets with strong healthcare infrastructure; potential gains in emerging markets with strategic investments.
• Investment in R&D: Ongoing R&D for next-generation SPRMs or new formulations can sustain long-term revenue streams.

Case Studies and Market Data

• Ella’s Sales Performance: U.S. sales peaked in 2018, but have plateaued due to generic competition and pricing pressures (IQVIA, 2022). Similar patterns observed in Europe suggest an approaching revenue plateau unless differentiated indications expand.

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Challenges and Opportunities

Challenges	Opportunities
Patent expiration leading to generics	Diversification into additional indications
Restrictive prescribing policies	Advocacy and policy engagement to broaden access
Competition from OTC levonorgestrel drugs	Potential development of longer-acting formulations
Cultural and regulatory barriers	Strategic regional expansion

Emerging opportunities include developing combination therapies, novel formulations with extended window of use, and expanding into regions with limited current access.

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Regulatory and Market Outlook

The regulatory environment will continue to evolve, with authorities favoring safe, accessible reproductive health options. Policymakers' willingness to liberalize access, combined with public health initiatives promoting women’s reproductive rights, can accelerate ELLA’s adoption. However, patent expiries and the entrance of low-cost generics will necessitate strategic price adjustments and marketing differentiation.

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Key Takeaways

• Market potential remains substantial despite intensifying competition, particularly in emerging regions with increasing awareness and demand for effective emergency contraception.
• Patent expiry around 2020 paves the way for generics, likely reducing ELLA’s market share and prices over time, influencing revenue trajectories.
• Regulatory and policy factors significantly impact access and prescribing patterns; proactive engagement is crucial for sustaining growth.
• Diversification through expanded indications and geographic expansion offers avenues for revenue enhancement beyond traditional markets.
• Investment in R&D for next-generation formulations and novel therapeutics can secure long-term market relevance amid evolving competition.

Strategic Actions for Stakeholders:

• Monitor patent landscapes and prepare for generic entry by optimizing branding and expanding indications.
• Engage with regulators and policymakers to facilitate broader access policies.
• Invest in market-specific educational campaigns to increase prescription rates and patient awareness.
• Explore partnerships in emerging markets to capitalize on demographic shifts and increasing healthcare investments.

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FAQs

1. What is the primary advantage of ELLA over OTC emergency contraceptives?
   ELLA offers higher efficacy, a broader window of use (up to 120 hours post-coitus), and requires medical consultation, ensuring appropriate use and management of side effects.

2. How will patent expiries impact ELLA’s market share?
   Patent expiries enable generic manufacturers to produce lower-cost versions, increasing price competition and potentially reducing ELLA’s market share and profit margins.

3. Are there ongoing innovations for emergency contraception that could threaten ELLA?
   Yes, research into non-hormonal options and long-acting reversible contraceptives may influence future demand, but currently, ELLA maintains a competitive edge due to efficacy and regulatory approval.

4. Which regions offer the highest growth potential for ELLA?
   Emerging markets in Asia, Africa, and Latin America exhibit high growth potential owing to increasing awareness, expanding healthcare infrastructure, and rising contraceptive demand.

5. What regulatory trends could influence ELLA’s future?
   Regulatory movements toward liberalizing access, expanding indications, and streamlining approvals can accelerate ELLA’s market presence; conversely, restrictive policies could hinder growth.

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References

[1] European Medicines Agency. (2015). EMA approves ulipristal acetate for emergency contraception. EMA Press Release.