ULIPRISTAL ACETATE - Generic Drug Details

What are the generic drug sources for ulipristal acetate and what is the scope of patent protection?

Ulipristal acetate is the generic ingredient in two branded drugs marketed by Lab Hra Pharma and Teva Pharms Usa, and is included in two NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ulipristal acetate has sixty-five patent family members in twenty-eight countries.

There are six drug master file entries for ulipristal acetate. Two suppliers are listed for this compound.

Summary for ULIPRISTAL ACETATE

International Patents:	65
US Patents:	8
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	57
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ULIPRISTAL ACETATE
What excipients (inactive ingredients) are in ULIPRISTAL ACETATE?	ULIPRISTAL ACETATE excipients list
DailyMed Link:	ULIPRISTAL ACETATE at DailyMed

Recent Clinical Trials for ULIPRISTAL ACETATE

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

Sponsor	Phase
The University of Hong Kong	PHASE3
The Family Planning Association of Hong Kong	PHASE3
University of Colorado, Denver	Phase 2

See all ULIPRISTAL ACETATE clinical trials

Pharmacology for ULIPRISTAL ACETATE

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

Anatomical Therapeutic Chemical (ATC) Classes for ULIPRISTAL ACETATE

G03AD	Emergency contraceptives
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03XB	Progesterone receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for ULIPRISTAL ACETATE

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 ULIPRISTAL ACETATE

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			Y
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes
Teva Pharms Usa	LOGILIA	ulipristal acetate	TABLET;ORAL	207952-001	Feb 13, 2017	AB	RX	No	No
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes			Y

EU/EMA Drug Approvals for ULIPRISTAL ACETATE

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 ULIPRISTAL ACETATE

Country	Patent Number	Title	Estimated Expiration
New Zealand	595790	METHOD FOR ON-DEMAND CONTRACEPTION
Russian Federation	2542779	СПОСОБ КОНТРАЦЕПЦИИ, ИСПОЛЬЗУЕМЫЙ ПО МЕРЕ НЕОБХОДИМОСТИ (BIRTH CONTROL TECHNIQUE USED AS AND WHEN NECESSARY)
European Patent Office	3103445	COMPRIMÉS D'ACÉTATE D'ULIPRISTAL (ULIPRISTAL ACETATE TABLETS)
Slovenia	2365800
Japan	2016188232	オンデマンド避妊方法 (METHOD FOR ON-DEMAND CONTRACEPTION)

Ulipristal Acetate: Market Dynamics and Financial Trajectory

Last updated: February 12, 2026

Overview

Ulipristal acetate (UPA) is a selective progesterone receptor modulator approved for emergency contraception and preoperative treatment of symptomatic uterine fibroids. Its core markets include North America, Europe, and parts of Asia, with expansion potential into additional territories.

Regulatory Status and Market Access

• United States: UPA marketed as Ella for emergency contraception since 2010 under license from HRA Pharma, now owned by Pfizer.
• European Union: Approved for emergency contraception (brand name ellaOne) and fibroid treatment.
• Japan & Other Countries: Approval timed variably, with some markets still evaluating regulatory pathways.
• Regulatory hurdles include safety concerns about potential liver toxicity, leading to restricted use guidelines in some jurisdictions.

Market Size and Growth Drivers

• Emergency Contraception (EC):
  The global EC market totalled approximately $1.2 billion in 2022. UPA accounts for roughly 60% of prescription EC sales in North America and Europe.
• Uterine Fibroids:
  The fibroid market was valued at around $6 billion in 2022, with UPA capturing about 10% of this segment through preoperative treatments.
• Growth Rates:
  The EC sector experiences a compound annual growth rate (CAGR) of approximately 4-6%. UPA's market share in EC has slightly increased over the past five years, driven by increased awareness and availability of new formulations.

Market Challenges

• Safety Concerns:
  Liver toxicity risk led to the EMA’s temporary suspension of ellaOne in 2018, which was lifted upon further safety review. Such concerns restrict broader market penetration and practitioner confidence.
• Competitive Landscape:
  Oral levonorgestrel-based pills dominate EC markets, with UPA holding a premium position due to higher efficacy within five days post-unprotected sex.
• Pricing and Reimbursement:
  Price points differ widely; reimbursement policies influence uptake, especially in publicly funded healthcare systems.

Financial Trajectory Projections

• Revenue Estimations:
  Pfizer projected the global Ella franchise (including UPA for EC) to generate approximately $300 million in 2022. Anticipated CAGR is 3-5%, contingent on regulatory and safety developments.
• Market Penetration:
  Expansion into emerging markets—such as Southeast Asia and Latin America—could boost revenues by 15-20% over five years, assuming regulatory approvals.
• Pipeline Potential:
  Novel formulations, extended indications (e.g., endometriosis treatment), and combination therapies could diversify revenue streams.

Key Influencing Factors

Factor	Impact	Notes
Regulatory changes	Positive/Negative	Revisions could expand or restrict access.
Safety profile	Critical	Liver risk influences market size and brand reputation.
Competitive innovations	High	New EC agents or alternatives like levonorgestrel generics.
Public awareness	Moderate	Education campaigns influence usage frequency.
Reimbursement policies	Significant	Affect overall affordability and sales volume.

Potential Growth Opportunities

• Expansion of UPA's indications to other gynecologic conditions, such as stopping abnormal uterine bleeding.
• Development of long-acting formulations or innovative delivery methods.
• Tailoring marketing strategies to increase penetration in underdeveloped regions.

Risks and Uncertainties

• Safety controversies may reduce prescribing confidence.
• Regulatory delays or bans in sizeable markets can hinder revenue growth.
• Competitive pressures increase as other emergency contraceptives gain market share.

Key Takeaways

• UPA remains a niche but significant player in emergency contraception and uterine fibroid treatment.
• Regulatory and safety factors heavily influence its market trajectory.
• Revenues are projected to grow modestly, with potential upswings via geographic expansion and new indications.
• The overall market environment is mature, with moderate growth prospects primarily driven by demographic and awareness shifts.

FAQs

1. How does ulipristal acetate compare with levonorgestrel-based emergency contraceptives?
   UPA is more effective within five days post-unprotected intercourse, especially in cases where levonorgestrel fails or is contraindicated.

2. What safety concerns are associated with ulipristal acetate?
   The primary concern is severe liver injury, leading to restrictions and extended monitoring requirements.

3. Are there opportunities to expand ulipristal acetate’s indications?
   Yes, ongoing research explores its potential in treating conditions like endometriosis and fibroid-related bleeding.

4. How do regulatory decisions impact market revenues?
   Positive approvals expand access; bans or restrictions limit sales and affect brand perception.

5. What are the prospects for market growth in emerging economies?
   High, assuming regulatory approval and affordability improvements, potentially doubling current market size over five years.

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Sources

[1] IQVIA, "Global Emergency Contraceptive Market Report," 2022.
[2] Pfizer, "Ella (Ulipristal Acetate) Product Info," 2022.
[3] European Medicines Agency, "EMA Safety Review of EllaOne," 2018.
[4] Grand View Research, "Uterine Fibroids Market Size, Share & Trends," 2022.