Talazoparib tosylate - Generic Drug Details

What are the generic sources for talazoparib tosylate and what is the scope of freedom to operate?

Talazoparib tosylate is the generic ingredient in one branded drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Talazoparib tosylate has ninety-seven patent family members in thirty-two countries.

Two suppliers are listed for this compound.

Summary for talazoparib tosylate

International Patents:	97
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	10
Patent Applications:	610
DailyMed Link:	talazoparib tosylate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for talazoparib tosylate

Dosage:

CAPSULE;ORAL

Dosage:

CAPSULE;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.

Recent Clinical Trials for talazoparib tosylate

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

Sponsor	Phase
Stanford University	Phase 2
Roswell Park Cancer Institute	Phase 1
Pfizer	Phase 1

See all talazoparib tosylate clinical trials

Pharmacology for talazoparib tosylate

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for talazoparib tosylate

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

US Patents and Regulatory Information for talazoparib tosylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-004	Mar 7, 2024		RX	Yes	No			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-005	Jun 20, 2023		DISCN	Yes	No			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-002	Mar 7, 2024		RX	Yes	No

International Patents for talazoparib tosylate

Country	Patent Number	Title	Estimated Expiration
South Korea	20110040973	DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE (PARP)
Netherlands	301021
Japan	2018012698	ポリ（ＡＤＰ−リボース）ポリメラーゼ（ＰＡＲＰ）のジヒドロピリドフタラジノン阻害剤 (DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE (PARP))

Supplementary Protection Certificates for talazoparib tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	122019000108	Germany		PRODUCT NAME: TALAZOPARIB ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1377 20190620
2767537	301021	Netherlands		PRODUCT NAME: TALAZOPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1377 20190624
2767537	2019/060	Ireland		PRODUCT NAME: TALAZOPARIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; NAT REGISTRATION NO/DATE: EU/1/19/1377/001 EU/1/19/1377/006 20190620; FIRST REGISTRATION NO/DATE: EU/1/19/1377/001 EU/1/19/1377/006 20190620 (20200708)

Market Dynamics and Financial Trajectory for TALAZOPARIB TOSYLATE

Last updated: October 17, 2025

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Introduction

Talazoparib tosylate, marketed under the brand name Talzenna among others, is a potent poly (ADP-ribose) polymerase (PARP) inhibitor approved primarily for the treatment of BRCA-mutated, HER2-negative advanced breast cancer. Its unique mechanism of action, targeting DNA repair pathways, underscores its significance in personalized oncology. As an emerging blockbuster within the PARP inhibitor class, talazoparib's market dynamics and financial prospects are shaped by clinical efficacy, regulatory milestones, competitive landscape, and evolving cancer treatment paradigms.

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Market Landscape and Drivers

1. Growing Incidence of Targeted Cancers

The incidence of breast cancer remains high globally, accentuated by the prevalence of BRCA1/2 mutations among high-risk populations. According to the International Agency for Research on Cancer (IARC), breast cancer accounts for 11.7% of all new cancer cases worldwide [1]. The subset of BRCA-mutated cancers, representing approximately 5-10% of breast carcinomas, benefits markedly from PARP inhibitors' targeted action. The increasing identification of genetic biomarkers propels patient stratification, raising demand for agents like talazoparib.

2. Expanding Approved Indications

Initially granted approval by the FDA in October 2018 for germline BRCA-mutated HER2-negative metastatic breast cancer, talazoparib's indications are expanding. Recent clinical trials investigate its efficacy in other malignancies, including ovarian and pancreatic cancers, broadening its potential market (e.g., EMBRACA trial results [2]). Regulatory agencies globally are reviewing similar labels, contingent on pivotal trial outcomes, thus underpinning future revenue streams.

3. Competitive Landscape and Differentiation

Talazoparib faces direct competition from other PARP inhibitors, notably olaparib (Lynparza) and rucaparib (Rubraca). While all target homologous recombination repair pathways, talazoparib's high PARP-trapping potency offers a potential efficacy advantage. Moreover, its relatively favorable safety profile influences patient adherence and clinical positioning. Market share dynamics depend heavily on head-to-head clinical data, physician preference, and regulatory approvals.

4. Increasing Adoption in Combination Therapies

Studies investigate combining talazoparib with agents like radiotherapy, immunotherapies, and chemotherapies, potentially opening new markets. Such combinations aim to enhance efficacy, especially in resistant tumors. Market adoption hinges on positive trial outcomes, safety considerations, and reimbursement policies.

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Regulatory and Reimbursement Factors

1. Approvals Beyond the United States

The FDA’s approval in 2018 catalyzed market entry, but the global landscape remains variable. The European Medicines Agency (EMA) approved talazoparib in 2019, with subsequent approvals in Japan, Canada, and other countries. Each regulatory milestone elevates sales prospects, especially with expanding indications.

2. Reimbursement and Pricing Strategies

Pricing strategies reflect the drug’s value proposition, market competitiveness, and healthcare system structures. As a targeted therapy for a specific subgroup, talazoparib commands premium pricing, with cost-effectiveness supported by clinical benefits [3]. Negotiations with payers influence market access, critical in emerging markets.

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Financial Trajectory and Revenue Forecasts

1. Revenue Estimates and Growth Potential

In its initial years post-launch, talazoparib generated approximately $300 million worldwide in 2021, primarily in the U.S., EU, and Japan [4]. Analysts project compound annual growth rates (CAGR) between 12-18% over the next five years, driven by broader indications, geographic expansion, and combination therapy approvals.

2. Impact of Clinical Progress and Label Expansion

Successful phase 3 trials in ovarian and pancreatic cancers are poised to significantly augment revenues. For example, positive results in ovarian cancer could open a market worth over $1 billion globally due to the high prevalence of BRCA mutations in ovarian carcinoma [5].

3. Competitive and Regulatory Risks

Potential setbacks include unfavorable trial outcomes, regulatory delays, or safety concerns diminishing market share. Patent expirations within the coming decade could also impact profitability, emphasizing the importance of pipeline development and lifecycle management.

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Market Challenges and Opportunities

Challenges

• Pricing and Reimbursement Constraints: Increased scrutiny on drug pricing may pressure margins.
• Competitive Pressure: Olaparib’s broader label and entrenched market position pose significant competition.
• Resistance Development: Tumor resistance to PARP inhibitors necessitates combination strategies and second-line agents.

Opportunities

• Biomarker-Driven Personalized Medicine: Enhancing diagnostic capabilities can identify eligible patient populations, expanding market share.
• Combination Therapies: Synergistic regimens can provide incremental benefits and extend lifecycle.
• Emerging Markets: Growing healthcare infrastructure facilitates access, promising incremental revenues.

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Conclusion

Talazoparib tosylate's market trajectory hinges on its clinical efficacy, expanding indications, regulatory approvals, and strategic positioning against competitors. While current revenues depict a promising outlook, sustained growth depends on successful clinical development, proactive market access strategies, and innovations in combination treatments. As personalized oncology advances, talazoparib’s role within the PARP inhibitor paradigm establishes it as a significant, albeit competitive, player in targeted cancer therapy.

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Key Takeaways

• Market Opportunity: Significant growth potential exists driven by expanding approvals, indications, and combination strategies.
• Competitive Edge: Talazoparib’s high potency and favorable safety profile offer differentiators within PARP inhibitors.
• Regulatory Outlook: Successful label expansions in ovarian and other cancers are pivotal for revenue diversification.
• Pricing & Access: Strategic pricing and reimbursement negotiations remain critical in maximizing market penetration.
• Innovation Focus: Investment in biomarker diagnostics and combination approaches will sustain future growth.

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FAQs

1. What distinguishes talazoparib from other PARP inhibitors?
   Talazoparib demonstrates higher PARP-trapping potency, which may translate to increased anti-tumor activity and improved efficacy in certain patient subsets.

2. What are the primary indications for talazoparib today?
   Currently approved for germline BRCA-mutated, HER2-negative metastatic breast cancer, with ongoing trials aiming for additional approvals in ovarian and pancreatic cancers.

3. What challenges could impede talazoparib’s market growth?
   Competition from established agents like olaparib, reimbursement negotiation difficulties, potential resistance development, and regulatory hurdles.

4. How is the global market for talazoparib expected to evolve?
   International approvals and expanded indications, coupled with increasing genetic testing, are likely to drive global uptake, especially in Europe, Asia, and emerging markets.

5. What strategic moves can pharmaceutical companies pursue to maximize talazoparib’s potential?
   Expanding indications, investing in combination therapy research, improving diagnostic tools for patient stratification, and fostering payer relationships are vital strategies.

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References

[1] International Agency for Research on Cancer. Global Cancer Statistics 2020.

[2] EMBRACA Trial Results. The New England Journal of Medicine, 2018.

[3] Cost-Effectiveness Analysis of Talazoparib. Cancer Management and Research, 2020.

[4] Company Financial Reports, 2021.

[5] Market Analysis on Ovarian Cancer PARP Inhibitors. MarketWatch, 2022.