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:	76
Patent Applications:	467
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/001027 Emergency 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/005017 Ulipristal 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
World Intellectual Property Organization (WIPO)	2011069871
Canada	2757496	METHODE DE CONTRACEPTION A LA DEMANDE (METHOD FOR ON-DEMAND CONTRACEPTION)
South Korea	101733533
Canada	2745084	COMPRIMES D'ULIPRISTAL ACETATE (ULIPRISTAL ACETATE TABLETS)
Cyprus	1118236
Hong Kong	1232134	烏利司他醋酸片 (ULIPRISTAL ACETATE TABLETS)
Russian Federation	2542779	СПОСОБ КОНТРАЦЕПЦИИ, ИСПОЛЬЗУЕМЫЙ ПО МЕРЕ НЕОБХОДИМОСТИ (BIRTH CONTROL TECHNIQUE USED AS AND WHEN NECESSARY)

Market Dynamics and Financial Trajectory for Ella (Ulipristal Acetate)

Market Overview

The U.S. emergency contraceptive pills market, which includes Ella (ulipristal acetate), is experiencing significant growth driven by increasing awareness about contraception and family planning, as well as the rising prevalence of unintended pregnancies.

Market Size and Growth

The U.S. emergency contraceptive pills market, including Ella, was estimated at USD 3.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5.24% from 2023 to 2030, reaching USD 5.1 billion by 2030[1].

Types of Emergency Contraceptive Pills

Ella is part of the ulipristal acetate segment, which, although not the largest, is expected to witness significant growth. Here are the key segments:

Progesterone Pills

This segment dominated the market with a 45.3% revenue share in 2022, driven by the high efficacy rate of 85% when used perfectly[1].

Combination Pills

Combination pills, including estrogen-progestin birth control pills, are the most used form of emergency contraception in the U.S., with an efficacy rate of 75%. This segment is expected to witness the fastest CAGR during the forecast period[1].

Ulipristal Acetate (Ella)

Ella, an antiprogestin, is effective for up to 120 hours after unprotected intercourse. Despite its effectiveness, it is less widely available than other options like Plan B. Only 5% of pharmacies in southwestern Pennsylvania had Ella readily accessible in 2021, highlighting the need for improved availability and awareness[1][3].

Distribution Channels

The retail store segment holds the largest market share of 56.4% in 2022, with pharmacies offering easy access to family planning services and healthcare facilities. Online stores and other distribution channels also contribute to the market but to a lesser extent[1].

Regional Outlook

The Southeast region dominated the U.S. emergency contraceptive pills market with a 28.6% revenue share in 2022, primarily due to the high prevalence of unintended pregnancies and abortion bans in the region. The Midwest is expected to witness the fastest growth rate due to similar factors[1].

Efficacy and Safety of Ella

Ella has a demonstrated safety record comparable to Plan B and can be used safely without a prescription. It remains effective for a longer period than Plan B, up to 120 hours after unprotected intercourse, and is more effective at preventing pregnancy, especially at higher weights[3][4].

Clinical Trials

Clinical trials have shown that Ella significantly reduces the pregnancy rate when taken 48 to 120 hours after unprotected intercourse. For instance, in one study, the observed pregnancy rate was 2.2% compared to an expected rate of 5.5% without emergency contraception[2].

Adverse Reactions

Common adverse reactions to Ella include headache, nausea, abdominal and upper abdominal pain, dysmenorrhea, fatigue, and dizziness. These reactions are generally mild and temporary[2].

Availability and Access

Despite its effectiveness, Ella is less frequently available than Plan B. Only 21.1% of California pharmacists reported that their pharmacy provides Ella without an outside provider's prescription, compared to 78.9% for Plan B. This disparity highlights the need for increased availability and awareness of Ella[3].

Cost and Insurance Coverage

Ella typically costs around $50 or more at pharmacies but can be free or low-cost with health insurance or Medicaid. Under the Affordable Care Act, most insurance plans must cover prescription birth control, including Ella[4].

Regulatory Considerations

The FDA has approved Ella for emergency contraception, but it remains a prescription-only medication in the U.S. Advocates suggest that the FDA should follow the European Medicines Agency's lead and make ulipristal acetate available over-the-counter to improve access[3].

Financial Trajectory

The financial trajectory for Ella is tied to the overall growth of the emergency contraceptive pills market. As awareness and demand for effective emergency contraception options increase, the market for Ella is expected to expand. Here are some key financial indicators:

Revenue Growth

The ulipristal acetate segment, including Ella, is expected to grow significantly, contributing to the overall market growth of 5.24% CAGR from 2023 to 2030[1].

Market Share

While the progesterone pills segment currently dominates, the combination pills and ulipristal acetate segments are expected to grow rapidly, potentially increasing Ella's market share over time[1].

Pricing and Revenue

Ella's pricing, typically around $50, and its coverage under health insurance plans contribute to its revenue. As more pharmacies and online stores make Ella available, its revenue is expected to increase[4].

Key Players

Several key players operate in the U.S. emergency contraceptive pills market, including Afaxys Pharma LLC, Teva Pharmaceutical Industries Ltd., and HRA Pharma, the manufacturer of Ella. These companies play a crucial role in the distribution and marketing of emergency contraceptive pills[1].

Conclusion

The market dynamics for Ella (ulipristal acetate) are driven by increasing demand for effective emergency contraception, regulatory considerations, and the need for improved availability. As the U.S. emergency contraceptive pills market grows, Ella is poised to play a significant role due to its efficacy and safety profile.

Key Takeaways

• Market Growth: The U.S. emergency contraceptive pills market is expected to grow at a CAGR of 5.24% from 2023 to 2030.
• Efficacy: Ella is more effective than other emergency contraceptive options and remains effective for up to 120 hours.
• Availability: Despite its effectiveness, Ella is less widely available than Plan B, highlighting the need for improved access.
• Cost and Insurance: Ella is typically priced around $50 but can be free or low-cost with health insurance or Medicaid.
• Regulatory Considerations: Advocates suggest making Ella available over-the-counter to improve access.

FAQs

Q: What is Ella, and how does it work?

Ella (ulipristal acetate) is an emergency contraceptive pill that works by delaying or preventing ovulation. It is effective up to 120 hours after unprotected intercourse.

Q: How effective is Ella compared to other emergency contraceptives?

Ella is more effective than Plan B, especially at higher weights, and remains effective for a longer period, up to 120 hours after unprotected intercourse[3].

Q: Why is Ella less available than Plan B?

Ella is less frequently available due to lower prescription rates by pharmacists and less widespread distribution compared to Plan B[3].

Q: Can Ella be purchased over-the-counter?

Currently, Ella is available only by prescription in the U.S., but there are advocacy efforts to make it available over-the-counter to improve access[3].

Q: Is Ella covered by health insurance?

Yes, under the Affordable Care Act, most insurance plans must cover prescription birth control, including Ella, making it free or low-cost for many users[4].

Sources

1. Grand View Research: U.S. Emergency Contraceptive Pills Market Report, 2030
2. FDA: Ella (ulipristal acetate) tablet - accessdata.fda.gov
3. UCLA Law: Access to ella® Emergency Contraception at California Pharmacies
4. Planned Parenthood: What is the ella Morning-After Pill? | Cost & Effectiveness
5. FDA: 22474 Ella Clinical PREA - FDA