ella Drug Patent Profile

Which patents cover Ella, and when can generic versions of Ella launch?

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. Two 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:	2
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

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	METHODE DE CONTRACEPTION A LA DEMANDE (METHOD FOR ON-DEMAND CONTRACEPTION)
Canada	2745084	COMPRIMES D'ULIPRISTAL ACETATE (ULIPRISTAL ACETATE TABLETS)
Russian Federation	2542779

Market Dynamics and Financial Trajectory for Ella (ulipristal acetate)

Last updated: February 19, 2026

What is Ella and how does it position within the emergency contraceptive market?

Ella (ulipristal acetate) is a prescription-only emergency contraceptive approved by the FDA in 2015. It is indicated for the prevention of pregnancy within five days (120 hours) after unprotected intercourse or contraceptive failure. Compared to OTC options like Plan B One-Step (levonorgestrel), Ella offers higher efficacy, especially closer to ovulation.

Market Overview

Market Size and Growth

• The global emergency contraceptive market was valued at approximately $2.5 billion in 2022.
• Compound annual growth rate (CAGR): 8.3% (2022-2029), driven by increasing demand for on-demand contraception and changing societal attitudes toward family planning.
• North America accounts for roughly 45% of the market; Europe holds approximately 30%.

Drivers

• Rising awareness of reproductive rights.
• Expansion of OTC access in some regions, increasing overall demand.
• Legal and cultural changes favoring contraceptive access.

Constraints

• Regulatory hurdles restrict Ella’s OTC availability outside the U.S., limiting market expansion.
• Market penetration faced issues due to competition from generic brands and OTC formulations.

Competitive Landscape

Product Name	Type	Availability	Key Features	Market Share (2022)
Ella (ulipristal acetate)	Prescription-only	U.S., select countries	Efficacious within 5 days, prescription-based	20%
Plan B One-Step	OTC levonorgestrel	Global, OTC	72-hour window, lower cost	50%
Next Choice, others	OTC levonorgestrel	Global, OTC	Similar to Plan B	30%

Notes: Ella’s lower market share results from regulatory restrictions and consumer awareness.

Regulatory and Policy Influences

• In the U.S., Ella remains prescription-only, limiting access.
• Some European countries, such as the UK, permit OTC access for Ella, broadening market potential.
• Ongoing regulatory reviews and patent statuses influence future market dynamics.

Patent and Pricing

• Ella's patent expired in 2020, leading to a surge in generic formulations.
• Brand price in the U.S.: approximately $50-70 per dose.
• Generic versions have reduced prices by approximately 40-50%, impacting Eli Lilly’s revenue.

Financial Trajectory

Revenue Trends

• Eli Lilly’s Ella sales peaked at around $250 million in 2016.
• Post-generic entry (2020 onward), sales declined to approximately $60 million by 2023.
• The decline reflects increased competition and reduced pricing power.

Profitability

• The product’s margins diminished with generic entry, reducing overall profitability.
• The company shifted focus toward expanding access in regions where Ella remains prescription-only.

Investment and Future Outlook

• R&D efforts focus on next-generation contraceptives and non-hormonal options.
• Regulatory negotiations for potential OTC approval in the U.S. could open new revenue streams.
• Strategic partnerships with pharmacies and health providers could mitigate some market restrictions.

Strategic Considerations

• Expanding OTC availability could increase market penetration.
• Navigating patent landscapes remains critical for maintaining competitive advantage.
• Developing combination products and positioning Ella within broader reproductive health portfolios offers growth potential.

Summary of Key Market and Financial Insights

Aspect	Observation
Market size (2022)	$2.5 billion
CAGR (2022-2029)	8.3%
Key regions	North America (45%), Europe (30%)
Main competitors	OTC levonorgestrel products
Ella’s market share (2022)	20%
Revenue (2023)	~$60 million (post-generic decline)
Patent status	Expired in 2020
Pricing	$50-70 per dose

Key Takeaways

• Ella occupies a niche in the emergency contraceptive market with high efficacy but faces significant sales pressure due to patent expiration and OTC alternatives.
• Regulatory environments heavily influence market access and growth opportunities.
• Future revenue depends on expanded OTC availability in the U.S. and regulatory approvals in emerging markets.
• Competitive pricing and product differentiation remain vital in a saturated market.

FAQs

1. How does Ella's efficacy compare to OTC options like Plan B?
   Ella maintains higher efficacy within five days post-intercourse, especially near ovulation, with a 98% success rate compared to 89% for levonorgestrel-based products.

2. What are the main barriers to Ella's OTC approval in the U.S.?
   Regulatory barriers include concerns about safety, the need for prescription counseling, and existing patent disputes.

3. How will patent expiry impact Eli Lilly's revenue streams?
   The patent expiry in 2020 led to generic competition, significantly reducing sales and profit margins.

4. Are there emerging markets where Ella could see growth?
   Yes, countries with evolving reproductive health policies, such as Brazil and India, present opportunities if regulatory access improves.

5. What future developments could influence Ella’s market position?
   Regulatory shifts toward OTC access, new formulations, and partnerships with health providers could reshape Ella’s market presence.

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References

[1] MarketResearch.com. (2023). Global Emergency Contraceptive Market Report.
[2] Eli Lilly & Co. Annual Reports. (2016-2023).
[3] U.S. Food and Drug Administration. (2015). Ella (ulipristal acetate) prescribing information.
[4] European Medicines Agency. (2022). Contraceptive drugs overview.
[5] Statista. (2023). Emergency contraceptive market size and forecast.