Abiraterone acetate - Generic Drug Details

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

Abiraterone acetate is the generic ingredient in four branded drugs marketed by Amneal Pharms, Apotex, Dr Reddys, Florida, Glenmark Speclt, Hikma, MSN, Mylan, Novugen, Qilu, Rising, Teva Pharms Usa, Wockhardt Bio Ag, Sun Pharm, and Janssen Biotech, and is included in eighteen NDAs. There are thirteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate has fifty-eight patent family members in twenty-six countries.

There are twenty-two drug master file entries for abiraterone acetate. Twenty-six suppliers are listed for this compound.

Summary for abiraterone acetate

International Patents:	58
US Patents:	13
Tradenames:	4
Applicants:	15
NDAs:	18
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	254
Patent Applications:	3,620
Drug Prices:	Drug price trends for abiraterone acetate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for abiraterone acetate
What excipients (inactive ingredients) are in abiraterone acetate?	abiraterone acetate excipients list
DailyMed Link:	abiraterone acetate at DailyMed

See drug prices for abiraterone acetate

Recent Clinical Trials for abiraterone acetate

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

Sponsor	Phase
Changhai Hospital	N/A
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	Phase 3

See all abiraterone acetate clinical trials

Pharmacology for abiraterone acetate

Drug Class	Cytochrome P450 17A1 Inhibitor
Mechanism of Action	Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors

Medical Subject Heading (MeSH) Categories for abiraterone acetate

Antineoplastic Agents

Cytochrome P-450 Enzyme Inhibitors

Steroid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for abiraterone acetate

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ABIRATERONE ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YONSA	Tablets	abiraterone acetate	125 mg	210308	1	2018-07-23
ZYTIGA	Tablets	abiraterone acetate	500 mg	202379	1	2017-08-23
ZYTIGA	Tablets	abiraterone acetate	250 mg	202379	13	2015-04-28

US Patents and Regulatory Information for abiraterone acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novugen	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	215947-002	Jan 5, 2022	AB	RX	No	No
Novugen	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	215947-001	Jan 5, 2022	AB	RX	No	No
Dr Reddys	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208416-001	May 18, 2020	AB	RX	No	No
Teva Pharms Usa	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	210726-001	Jan 26, 2023	AB	RX	No	No
Mylan	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208446-002	Dec 14, 2020	AB	RX	No	No
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	8,071,579
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-002	Apr 14, 2017	AB	RX	Yes	Yes

Expired US Patents for abiraterone acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-001	Apr 28, 2011	5,604,213

EU/EMA Drug Approvals for abiraterone acetate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Ireland Limited	Abiraterone Mylan	abiraterone acetate	EMEA/H/C/005368 Abiraterone Mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.	Authorised	yes	no	no	2021-08-20
Krka, d.d., Novo mesto	Abiraterone Krka	abiraterone acetate	EMEA/H/C/005649 Abiraterone Krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.	Authorised	yes	no	no	2021-06-24

International Patents for abiraterone acetate

Country	Patent Number	Title	Estimated Expiration
China	105246598	Abiraterone acetate formulation
Taiwan	201943408	Abiraterone acetate formulation
World Intellectual Property Organization (WIPO)	2016044701
Chile	2015002787	Formulación de acetato de abiraterona.
Eurasian Patent Organization	201790650	ЛЕКАРСТВЕННАЯ ФОРМА И СПОСОБЫ ПРИМЕНЕНИЯ АБИРАТЕРОНА АЦЕТАТА
Canada	2958316	FORMULATION D'ACETATE D'ABIRATERONE ET SES PROCEDES D'UTILISATION (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE)
South Korea	102617537

Supplementary Protection Certificates for abiraterone acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0633893	11C0055	France		PRODUCT NAME: ABIRATERONE, SES SELS D'ADDITION D'ACIDE ET 3-ESTERS, EN PARTICULIER ACETATE D'ABIRATERONE; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
0633893	2012/003	Ireland		PRODUCT NAME: ZYTIGA (ABIRATERONE) "ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF, ESPECIALLY ABIRATERONE ACETATE"; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
0633893	SPC/GB11/063	United Kingdom		PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905

Abiraterone acetate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Abiraterone Acetate

Introduction

Abiraterone acetate, a crucial drug in the treatment of advanced prostate cancer, has been witnessing significant growth and evolution in the pharmaceutical market. This article delves into the market dynamics, financial trajectory, and key factors influencing the abiraterone acetate market.

Increasing Prevalence of Prostate Cancer

One of the primary drivers of the abiraterone acetate market is the rising incidence of prostate cancer globally. Prostate cancer is the most common cancer in men, and the demand for effective treatment options is steadily increasing. This growing patient population creates a substantial market for abiraterone acetate and other targeted therapies[1].

Advancements in Drug Formulations

Ongoing research and development activities aimed at improving the efficacy and safety profiles of abiraterone acetate are another significant driver. Novel drug formulations with enhanced bioavailability and extended-release characteristics are being developed to improve patient compliance and treatment outcomes. These advancements contribute to the market's steady growth[1].

Growing Demand for Targeted Therapies

The increasing preference for targeted therapies, which offer better treatment outcomes with reduced side effects, is also driving the market. Targeted therapies specifically inhibit cancer cells, minimizing damage to healthy cells, making them a preferred choice over traditional treatments[1].

Regional Analysis

The abiraterone acetate market is segmented into several regions, with North America currently dominating due to the high prevalence of prostate cancer and well-established healthcare infrastructure. Europe is the second-largest market, followed by Asia Pacific, which is expected to witness significant growth due to improving healthcare facilities, increasing healthcare expenditure, and a growing patient population[1].

North America

North America's dominance is attributed to the high incidence of prostate cancer and the presence of advanced healthcare systems. This region is home to many key players in the pharmaceutical industry, which further fuels market growth.

Europe

Europe is the second-largest market for abiraterone acetate, driven by a high prevalence of prostate cancer and a robust healthcare system. European countries are also hubs for pharmaceutical research and development.

Asia Pacific

The Asia Pacific region is expected to experience significant growth due to improving healthcare infrastructure, increasing healthcare expenditure, and a growing patient population. Countries like China and India are becoming key markets due to their large populations and increasing healthcare needs.

Competitive Landscape

The abiraterone acetate market is highly competitive, with several key players vying for market share. Companies are adopting strategies such as mergers and acquisitions, collaborations, and product launches to maintain their market positions. Prominent companies operating in this market include those with a strong focus on product development and strategic partnerships[1].

Financial Considerations

Cost-Effectiveness

Despite its effectiveness, abiraterone acetate poses significant financial challenges. The cost of treatment is high, and its cost-effectiveness is a subject of debate. For instance, in the UK, the incremental cost-effectiveness ratio (ICER) for abiraterone acetate plus prednisone/prednisolone (AAP) is substantial, making it not cost-effective at current prices. However, scenario analyses suggest that it could be cost-effective if priced below certain thresholds[2].

Budgetary Impact

In the U.S., the budgetary impact of adopting abiraterone acetate on health plans is significant. Factors such as treatment duration and the market share of other treatments like cabazitaxel are key drivers of cost. These factors highlight the need for careful financial planning and negotiation to make the treatment more accessible[3].

Market Restraints

High Treatment Costs

One of the major restraints for the abiraterone acetate market is the high cost of treatment. This makes it inaccessible to many patients, especially in regions with limited healthcare resources.

Adverse Effects

Abiraterone acetate is associated with significant adverse effects, which can impact patient compliance and overall treatment outcomes. Managing these side effects is crucial for maintaining patient health and market growth.

Market Opportunities

Emerging Markets

Emerging regions, particularly in Asia Pacific, offer significant market opportunities due to their growing patient populations and improving healthcare facilities. Expanding into these markets can provide substantial growth opportunities for pharmaceutical companies.

Research and Development

Continuous research and development in drug formulations and delivery mechanisms offer opportunities for innovation and market expansion. Improving the efficacy and safety profiles of abiraterone acetate can further enhance its market position.

API Market Dynamics

The global abiraterone acetate API market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031. This growth is driven by the positive momentum in market dynamics, coupled with anticipated continued expansion. The API market undergoes a comprehensive assessment, examining drivers, restraints, opportunities, and challenges to unveil their impact on the market[4].

Support Programs

To address the financial burden of abiraterone acetate treatment, various support programs are available. For example, the YONSA SUPPORT® Co-Pay Card Program helps eligible, commercially insured patients access their prescriptions, making the treatment more affordable[5].

Key Takeaways

• The abiraterone acetate market is driven by the increasing incidence of prostate cancer, advancements in drug formulations, and the growing demand for targeted therapies.
• North America dominates the market, but Asia Pacific is expected to witness significant growth.
• The market is highly competitive, with key players focusing on product development and strategic collaborations.
• High treatment costs and adverse effects are major restraints.
• Emerging markets and ongoing research and development offer significant opportunities for growth.

FAQs

What are the primary drivers of the abiraterone acetate market?

The primary drivers include the increasing incidence of prostate cancer, advancements in drug formulations, and the growing demand for targeted therapies.

Which region currently dominates the abiraterone acetate market?

North America currently dominates the market due to the high prevalence of prostate cancer and well-established healthcare infrastructure.

What are the major restraints for the abiraterone acetate market?

High treatment costs and adverse effects are the major restraints for the market.

How is the cost-effectiveness of abiraterone acetate evaluated?

The cost-effectiveness is evaluated through incremental cost-effectiveness ratios (ICERs), which compare the additional cost to the health gains in terms of quality-adjusted life-years (QALYs).

What support programs are available to make abiraterone acetate more accessible?

Support programs like the YONSA SUPPORT® Co-Pay Card Program help eligible patients access their prescriptions by reducing the financial burden.

Sources:

1. MarkWide Research: Abiraterone Acetate Drugs market 2024-2032 | Size, Share, Growth
2. PLOS ONE: Lifetime decision model based on STAMPEDE trial data
3. PubMed: Budgetary impact on a U.S. health plan adopting abiraterone
4. Market Research Intellect: Global abiraterone acetate api market size and forecast
5. Yonsa Support: YONSA SUPPORT® programs provide a simple path to services