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. Four 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:	4
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	56
Patent Applications:	2,385
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
University of Colorado, Denver	Phase 2
University of North Carolina, Chapel Hill	Phase 2
University of Utah	Early Phase 1

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	10,159,681
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	10,772,897
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

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/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 ULIPRISTAL ACETATE

Country	Patent Number	Title	Estimated Expiration
Hungary	E029434
South Africa	201104137	ULIPRISTAL ACETATE TABLETS
New Zealand	593498	ULIPRISTAL ACETATE TABLETS
Colombia	6400186	TABLETAS DE ACETATO DE ULIPRISTAL

ULIPRISTAL ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ulipristal Acetate

Introduction

Ulipristal acetate, a selective progesterone receptor modulator (SPRM), has been a significant player in the pharmaceutical market, particularly for the treatment of uterine fibroids and as an emergency contraceptive. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Forecast

The ulipristal acetate market is projected to experience steady growth, with a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from 2023 to 2031. The market size is estimated to increase significantly, valued at several hundred million USD by 2031[1][4].

Segmentation

The market is segmented based on application, product purity, and geographical regions. Key segments include:

• Application: Ulipristal acetate tablets and other applications.
• Product Purity: Purity ≥98% and Purity ≥99%.
• Geography: North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[1][4].

Market Drivers

Several factors drive the growth of the ulipristal acetate market:

• Increasing Prevalence of Uterine Fibroids: The rising incidence of uterine fibroids among women of reproductive age drives the demand for effective treatments.
• Efficacy in Emergency Contraception: Ulipristal acetate's effectiveness as a single-dose emergency contraceptive contributes to its market demand.
• Clinical Trials and Approvals: Positive outcomes from clinical trials, such as the Venus I and II trials, have supported its use in various regions[3][5].

Market Restraints

Despite the growth potential, the market faces several restraints:

• Safety Concerns: The European Medicines Agency's (EMA) recommendation to revoke the marketing authorization for ulipristal acetate due to liver injury has significantly impacted its use for uterine fibroids in the EU. However, this does not affect its use as an emergency contraceptive[2].
• Regulatory Challenges: Regulatory hurdles, such as the FDA's extended review period for the New Drug Application (NDA) in the U.S., can delay market entry and expansion[3].

Geographical Performance

The market performance varies across different regions:

• Europe: Despite the EMA's recommendation against its use for uterine fibroids, ulipristal acetate remains approved for emergency contraception.
• North America: The drug is still under review for the treatment of uterine fibroids, with ongoing clinical trials and regulatory assessments.
• Asia-Pacific: This region is expected to show significant growth due to a large patient population and increasing healthcare expenditure[1][4].

Key Players

Several companies are prominent in the ulipristal acetate market:

• Allergan: Known for marketing ulipristal acetate under the trade name Esmya® in Europe.
• NewChem, Maiden Group, Hangzhou Think Chemical: Other key players involved in the production and distribution of ulipristal acetate[1][4].

Financial Performance

The financial trajectory of ulipristal acetate is influenced by its market dynamics:

• Revenue Growth: The market is expected to generate significant revenue, driven by its applications in both uterine fibroid treatment and emergency contraception.
• Patent Protection: Ulipristal acetate is protected by a patent that expires in 2029, which helps maintain its market exclusivity and revenue stream[3].

Consumer Behavior and Market Trends

Consumer behavior and market trends play a crucial role:

• Increasing Awareness: Growing awareness about the treatment options for uterine fibroids and emergency contraception drives consumer demand.
• Technological Advancements: Continuous research and development in SPRMs are expected to enhance the efficacy and safety profile of ulipristal acetate, further boosting its market position[4][5].

Regulatory Landscape

The regulatory landscape significantly impacts the market:

• EMA's Recommendation: The EMA's decision to revoke the marketing authorization for ulipristal acetate in the EU has had a profound impact on its use for uterine fibroids, but not for emergency contraception.
• FDA Review: The ongoing FDA review process in the U.S. will determine the future of ulipristal acetate in this market[2][3].

Future Outlook

Despite the challenges, the ulipristal acetate market is poised for growth:

• Emerging Markets: Expansion into emerging markets, particularly in the Asia-Pacific region, is expected to drive future growth.
• Diversification of Applications: Potential new applications and indications could further expand the market for ulipristal acetate[1][4].

Key Takeaways

• The ulipristal acetate market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
• Safety concerns and regulatory challenges, particularly in the EU, have impacted its use for uterine fibroids.
• The drug remains a significant player in emergency contraception.
• Key players are focusing on expanding their product portfolios and entering new markets.
• Emerging markets and potential new applications are expected to drive future growth.

FAQs

Q: What is the primary use of ulipristal acetate? A: Ulipristal acetate is primarily used for the treatment of moderate to severe symptoms of uterine fibroids and as an emergency contraceptive.

Q: Why was the marketing authorization for ulipristal acetate revoked in the EU? A: The EMA revoked the marketing authorization due to confirmed cases of liver injury, including the need for liver transplantation, associated with the use of ulipristal acetate for uterine fibroids[2].

Q: What is the current regulatory status of ulipristal acetate in the U.S.? A: Ulipristal acetate is still under review by the FDA for the treatment of uterine fibroids, with ongoing clinical trials and regulatory assessments[3].

Q: Which regions are expected to drive the future growth of the ulipristal acetate market? A: Emerging markets, particularly in the Asia-Pacific region, are expected to drive future growth due to a large patient population and increasing healthcare expenditure[1][4].

Q: What is the patent status of ulipristal acetate? A: Ulipristal acetate is protected by a patent that expires in 2029, which helps maintain its market exclusivity and revenue stream[3].

Sources

1. Market Research Intellect - Ulipristal Acetate Market Size And Forecast[1].
2. European Pharmaceutical Review - EMA recommends withdrawal of ulipristal acetate marketing authorisation[2].
3. Abbvie News - Allergan Announces FDA Has Extended The Ulipristal Acetate NDA Review Period To August 2018[3].
4. Cognitive Market Research - Global Ulipristal Acetate Market Report 2024 Edition[4].
5. Frontiers in Endocrinology - Ulipristal Acetate Interferes With Actin Remodeling Induced by 17β-Estradiol and Progesterone in Human Endometrial Stromal Cells[5].