ABIRATERONE ACETATE; NIRAPARIB TOSYLATE - Generic Drug Details

What are the generic drug sources for abiraterone acetate; niraparib tosylate and what is the scope of freedom to operate?

Abiraterone acetate; niraparib tosylate is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate; niraparib tosylate has two hundred and eighty-six patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

International Patents:	286
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
DailyMed Link:	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Constraining patent/regulatory exclusivity:

11,091,459

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Drug Class	Cytochrome P450 17A1 Inhibitor Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Poly(ADP-Ribose) Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

L01XK	Poly (ADP-ribose) polymerase (PARP) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

US Patents and Regulatory Information for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No	8,859,562
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	11,992,486
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	11,207,311
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	11,986,469
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No	11,986,469

International Patents for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Country	Patent Number	Title	Estimated Expiration
South Korea	20060052877	USE OF RNAI INHIBITING PARP ACTIVITY FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF CANCER
Mexico	2010006593	SALES FARMACEUTICAMENTE ACEPTABLES DE 2-{4-[(3S)-PIPERIDIN-3-IL]FE NIL}-2H-INDAZOL-7-CARBOXAMIDA. (PHARMACEUTICALLY ACCEPTABLE SALTS OF 2-{4-[(3S)-PIPERIDIN-3- YL]PHENYL} -2H-INDAZOLE-7-CARBOXAMIDE.)
Poland	2336120
China	110944638	尼拉帕尼组合物 (NIRAPARIB COMPOSITIONS)
Spain	2364140

Supplementary Protection Certificates for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1633724	S1500012	Hungary		PRODUCT NAME: OLAPARIB
2109608	300937	Netherlands		PRODUCT NAME: NIRAPARIB, OF EEN TAUTOMEER DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1235 20171120
2109608	18C1019	France		PRODUCT NAME: NIRAPARIB OU L'UN DE SES SELS,STEREOISOMERES OU TAUTOMERES PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER LE TOSYLATE OU HYDRATE DE TOSYLATE,PLUS PARTICULIEREMENT LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
1633724	PA2015016,C1633724	Lithuania		PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Abiraterone Acetate and Niraparib Tosylate

Introduction to Abiraterone Acetate and Niraparib Tosylate

Abiraterone acetate and niraparib tosylate are two significant drugs in the oncology sector, particularly for the treatment of various forms of cancer. Abiraterone acetate is primarily used for the treatment of prostate cancer, while niraparib tosylate is used for ovarian cancer and other BRCA-mutated cancers.

Market Dynamics of Abiraterone Acetate

Drivers of the Market

• Higher Incidence of Prostate Cancer: The global abiraterone acetate market is driven by the increasing incidence of prostate cancer. According to the American Cancer Society, approximately 248,530 new cases of prostate cancer were diagnosed in the U.S. in 2020, and 1,276,106 new cases were diagnosed worldwide in 2018[4].
• Introduction of New Formulations: The market is also boosted by the introduction of new formulations and strengths of abiraterone acetate. For example, Amneal Pharmaceuticals received approval for a 500 mg generic abiraterone acetate tablet in January 2021, and Dr Reddy’s Laboratories launched an abiraterone acetate tablet in the U.S. market after FDA approval in June 2020[4].

Geographical Performance

• North America: This region is expected to capture a major share of the global abiraterone acetate market due to the higher incidence of prostate cancer and the presence of key players. High disposable income and increased healthcare expenditure also contribute to the market growth in this region[4].
• Asia Pacific: The market in Asia Pacific is projected to expand rapidly due to the rising prevalence of prostate cancer and increasing awareness about the disease in the region[4].

Key Players

The global abiraterone acetate market is highly concentrated, with several key players holding significant market shares. Major players include Janssen Global Services, LLC, Dr Reddy’s Laboratories, Amneal Pharmaceuticals, and others. These companies adopt various growth strategies to drive the market forward[4].

Market Dynamics of Niraparib Tosylate

Drivers of the Market

• Increasing Incidence of Ovarian Cancer: The niraparib tosylate market is driven by the increasing incidence of ovarian cancer and other BRCA-mutated cancers. The drug's approval for these indications has significantly boosted its market[5].
• Clinical Efficacy: Niraparib tosylate has shown statistically significant improvements in clinical trials, such as the improvement in radiographic progression-free survival (rPFS) when combined with other treatments, which enhances its market appeal[3].

Geographical Performance

• Global Expansion: The niraparib tosylate market is expected to witness significant growth globally, driven by its approval in various regions and the increasing awareness of BRCA-mutated cancers[5].

Key Players

The niraparib tosylate market is dominated by key players such as Tesaro (now part of GSK), which has been instrumental in its development and marketing. Other pharmaceutical companies are also entering the market with generic or biosimilar versions, contributing to the market's growth[5].

Financial Trajectory of Abiraterone Acetate

Market Size and Growth

• The pharmaceutical grade abiraterone acetate market has experienced rapid growth in recent years and is forecasted to continue this trend from 2023 to 2031. The market size is expected to increase significantly, driven by the factors mentioned above[1].
• The market is segmented based on type (purity ≥99%, purity <99%) and application (tablet, others), with the tablet segment being a major contributor to the market revenue[1].

Revenue Projections

• The comprehensive market report indicates that the abiraterone acetate market will undergo substantial expansion, with revenue measured in USD million expected to rise significantly over the forecast period[1].

Financial Trajectory of Niraparib Tosylate

Market Size and Growth

• The global niraparib tosylate market was valued at a significant amount in 2023 and is anticipated to reach a higher value by 2030, witnessing a considerable CAGR during this period[5].
• The market growth is driven by the increasing adoption of niraparib tosylate in the treatment of ovarian cancer and other BRCA-mutated cancers, as well as its approval in various regions[5].

Revenue Projections

• The revenue projections for niraparib tosylate indicate a robust growth trajectory, with the market expected to expand significantly over the forecast period. This growth is supported by the drug's clinical efficacy and the increasing incidence of targeted cancers[5].

Regulatory Approvals and Impact

FDA Approvals

• Abiraterone Acetate: The FDA approved abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer in August 2023, which has significantly boosted its market potential[3].
• Niraparib Tosylate: Niraparib tosylate has received FDA approval for various indications, including ovarian cancer, which has been a key driver of its market growth[3].

Impact on Market Dynamics

• Regulatory approvals play a crucial role in the market dynamics of both drugs. These approvals not only validate the clinical efficacy of the drugs but also expand their market reach and acceptance among healthcare providers and patients[3].

Consumer Behavior and Awareness

Increasing Awareness

• There is an increasing awareness about prostate cancer and ovarian cancer, which is driving the demand for effective treatments like abiraterone acetate and niraparib tosylate. Patient advocacy groups and healthcare campaigns are contributing to this increased awareness[4][5].

Patient Preferences

• Patients are increasingly seeking targeted therapies that offer better outcomes and fewer side effects. Both abiraterone acetate and niraparib tosylate have been favored due to their targeted action and improved clinical outcomes, which aligns with patient preferences[4][5].

Economic, Political, and Social Landscapes

Economic Factors

• High disposable income and increased healthcare expenditure in regions like North America are driving the market for abiraterone acetate. Similarly, economic factors such as government healthcare policies and insurance coverage are influencing the niraparib tosylate market[4].

Political Factors

• Government regulations and policies play a significant role in the pharmaceutical industry. Approvals, pricing regulations, and reimbursement policies can all impact the market dynamics of these drugs[1][5].

Social Factors

• Social awareness campaigns and patient advocacy groups are crucial in increasing the adoption of these drugs. Public health initiatives aimed at early detection and treatment of cancers also contribute to the market growth[4][5].

Challenges and Opportunities

Challenges

• Competition: Both markets face competition from generic and biosimilar versions of the drugs, which can impact pricing and market share[4][5].
• Regulatory Hurdles: Navigating regulatory approvals and maintaining compliance with changing regulations can be challenging for pharmaceutical companies[1][5].

Opportunities

• Emerging Markets: The Asia Pacific region offers significant growth opportunities for both abiraterone acetate and niraparib tosylate due to the rising prevalence of cancers and increasing healthcare awareness[4][5].
• New Indications: The potential for these drugs to be approved for additional indications can further expand their market reach and revenue[3].

Key Takeaways

• The markets for abiraterone acetate and niraparib tosylate are driven by increasing cancer incidence, regulatory approvals, and the introduction of new formulations.
• North America and Asia Pacific are key regions for these markets due to high incidence rates and increasing healthcare expenditure.
• Regulatory approvals and clinical efficacy are crucial for the market growth of these drugs.
• Consumer awareness and patient preferences for targeted therapies are driving the demand for these drugs.
• Economic, political, and social factors significantly influence the market dynamics.

FAQs

What are the primary drivers of the abiraterone acetate market?

The primary drivers include the higher incidence of prostate cancer, introduction of new formulations, and high healthcare expenditure in regions like North America[4].

What is the significance of FDA approvals for abiraterone acetate and niraparib tosylate?

FDA approvals validate the clinical efficacy of these drugs and expand their market reach and acceptance among healthcare providers and patients[3].

Which regions are expected to drive the growth of the niraparib tosylate market?

The global niraparib tosylate market is expected to witness significant growth in various regions, with a notable expansion in the Asia Pacific due to increasing awareness and incidence of ovarian cancer[5].

How do economic factors influence the market for these drugs?

High disposable income and increased healthcare expenditure in regions like North America drive the market for these drugs. Government healthcare policies and insurance coverage also play a crucial role[4][5].

What are the challenges faced by the abiraterone acetate and niraparib tosylate markets?

Both markets face challenges from competition, regulatory hurdles, and the need to navigate changing regulatory landscapes[1][4][5].

Sources

1. Market Research Intellect: Global Pharmaceutical Grade Abiraterone Acetate Market Size, Scope And Forecast Report[1].
2. Market Research Intellect: Global Niraparib Tosylate Market Size, Scope And Forecast Report[2].
3. FDA: FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer[3].
4. Biospace: Abiraterone Acetate Drugs Market: Higher incidence of prostate cancer worldwide is expected to drive the market[4].
5. Valuates Reports: Niraparib Tosylate Market, Report Size, Worth, Revenue, Growth[5].