talazoparib tosylate - Profile

What are the generic drug 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.

Summary for talazoparib tosylate

International Patents:	97
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	2

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

Constraining patent/regulatory exclusivity:

8,735,392

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

8,735,392

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.

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	211651-005	Jun 20, 2023		DISCN	Yes	No	9,820,985
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-005	Jun 20, 2023		DISCN	Yes	No	10,780,088
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-005	Jun 20, 2023		DISCN	Yes	No	8,012,976		Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-005	Jun 20, 2023		DISCN	Yes	No	8,420,650		Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-005	Jun 20, 2023		DISCN	Yes	No	10,189,837		Y	Y

International Patents for talazoparib tosylate

Country	Patent Number	Title	Estimated Expiration
Argentina	083502	SAL TOSILADA DE (8S,9R)-5-FLUORO-8-(4-FLUOROFENIL)-9-(1-METIL-1H-1,2,4-TRIAZOL-5-IL)-8,9-DIHIDRO-2H-PIRIDO[4,3,2-DE]FTALAZIN-3(7H)-ONA CRISTALINA
Australia	2011317040	Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt
Australia	2017201564	CRYSTALLINE (8S,9R)-5-FLUORO-8-(4-FLUOROPHENYL)-9-(1-METHYL-1H-1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTHALAZIN-3(7H)-ONE TOSYLATE SALT
Brazil	112013009117	sal tosilato de (8s,9r)-5-fluor-8-(4-fluorefenil)-9-(1-metil-1h-1,2,4-triazol-5-il)-8,9-diidro-2h-pirido[4,3,2-de]ftalazin-3(7h)-ona, método para preparar uma forma cristalina e uso do mesmo,composição farmacêutica e método para tratar um câncer ou um sintoma do mesmo.
Canada	2814581	SEL TOSYLATE DE LA (8S,9R)-5-FLUORO-8-(4-FLUOROPHENYL)-9-(1-METHYL-1H- 1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTALAZIN-3(7H)-ONE CRISTALLIN (CRYSTALLINE (8S,9R)-5-FLUORO-8-(4-FLUOROPHENYL)-9-(1-METHYL-1H-1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTHALAZIN-3(7H)-ONE TOSYLATE SALT)

Supplementary Protection Certificates for talazoparib tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	C20190041 00311	Estonia		PRODUCT NAME: TALASOPARIIB;REG NO/DATE: EU/1/19/1377 24.06.2019
2767537	756	Finland
2767537	C02767537/01	Switzerland		FORMER OWNER: MEDIVATION TECHNOLOGIES LLC, US
2767537	408 19-2019	Slovakia		OWNER(S): MEDIVATION TECHNOLOGIES LLC, NEW YORK, NY, US; DATUM ZAPISU DO REGISTRA: 20.1.2022
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)

Investment Scenario, Market Dynamics, and Financial Trajectory for Talazoparib Tosylate

Last updated: February 3, 2026

Summary

Talazoparib tosylate, marketed as Talzenna by Pfizer, is a potent poly (ADP-ribose) polymerase (PARP) inhibitor approved for the treatment of BRCA-mutated locally advanced or metastatic breast cancer. As a targeted oncology therapy, Talazoparib is positioned within an expanding segment driven by personalized medicine, genetic testing, and the increasing prevalence of BRCA mutations. This analysis offers a comprehensive overview of its market outlook, competitive landscape, and financial prospects, integrating market data, R&D pipelines, regulatory status, and pricing considerations.

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What is the Pharmaceutical Profile of Talazoparib Tosylate?

Aspect	Details
Generic Name	Talazoparib
Brand Name	Talzenna (Pfizer)
Therapeutic Class	PARP inhibitor
Indication	BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer
Approval Date	October 2018 (FDA)
Mechanism of Action	Inhibits PARP enzymes, impairing DNA repair in BRCA-mutated cancer cells

Note: As a chemical entity, talazoparib is a potent inhibitor with a high binding affinity for PARP enzymes, offering advantages in efficacy over earlier PARP inhibitors such as olaparib and niraparib.

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Market Overview and Dynamics

Global Market Size and Growth Trends

Parameter	Data	Source
2022 Global PARP Inhibitor Market	USD 4.2 billion	[1]
Projected CAGR (2022-2028)	13.5%	[1]
Estimated 2028 Market Size	USD 10.4 billion	[1]

Segmentation Focus

Segment	Share of Total PARP Market (2022)	Key Drivers
Breast Cancer	56%	High BRCA mutation prevalence, expanded indications
Ovarian Cancer	29%	Monotherapy approvals, maintenance therapy uses
Prostate Cancer	10%	Emerging approvals, ongoing trials
Other (pancreatic, lung, etc.)	5%	Growing evidence, targeted therapy preference

Note: The breast cancer segment is the primary driver for talazoparib sales, given its initial approval and established indications.

Market Drivers

• Increasing detection of germline BRCA mutations.
• Rising incidence of breast cancer worldwide (estimated 2.3 million new cases annually in 2020, per WHO).
• Regulatory approvals expanding indications to early-line and adjuvant settings.
• Growing acceptance of personalized medicine and companion diagnostics.
• Competitive pipeline and diversification within PARP inhibitors.

Market Challenges

• Patent cliffs for key competitors.
• High cost and reimbursement barriers.
• Adverse event profiles affecting patient compliance.
• Competition from other PARP inhibitors (olaparib, niraparib, rucaparib).

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Competitive Landscape

Company	Product	Market Share (2022)	Key Indications	Patent Status
Pfizer	Talzenna	40%	Breast cancer, ovarian (pending label expansion)	Patented till 2030
AstraZeneca	Lynparza (Olaparib)	35%	Multiple cancer types	Patent expiry 2024-2029
GlaxoSmithKline	Zejula (Niraparib)	15%	Ovarian, breast	Patented till 2028
Clovis Oncology	Rubraca	10%	Ovarian, prostate	Patent expiry 2026

Note: Pfizer’s Talzenna maintains a leading position in breast cancer, aided by targeted marketing and ongoing clinical trials.

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Regulatory and R&D Trajectory

Year	Milestone	Impact
2018	FDA approval of Talazoparib	Market entry for advanced breast cancer indications
2020	Expanded label approvals (e.g., neoadjuvant)	Extended market potential
2022+	Trials in early-stage breast cancer	Potential boost to sales if approved
2023+	Regulatory filings for other cancers	Access to additional markets

Pipeline Overview

Development Stage	Indication	Candidate(s)	Key Milestones Expected
Pre-Clinical	Pan-cancer, combination therapies	Multiple pipeline programs	Further efficacy data
Phase 1-2	Prostate, pancreatic, colon	Multiple ongoing clinical studies	Data readouts in 2023-2024
Phase 3	Early line breast (adjuvant), ovarian	Pending filings and trial results	Variations in approval timelines

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Financial Trajectory and Investment Outlook

Revenue Estimation (2022-2028)

Year	Estimated Sales (USD billion)	Assumptions	Source/Methodology
2022	1.2	Initial launch effect, moderate uptake	Company filings & market data
2023	1.6	Expansion into early-line indications	Trial outcomes, regulatory filings
2024	2.0	Broader adoption, increased indications	Market penetration
2025	2.5	Commercial success, pipeline approvals	Projected pipeline success
2028	4.5	Market expansion, price adjustments	CAGR assumptions

Note: Peak sales could reach USD 4.5 billion by 2028, driven by indication expansion and higher adoption rates if pipeline progress remains favorable.

Pricing Trends and Reimbursement

Aspect	Details
Average Wholesale Price (AWP)	Approximately USD 10,000–12,000 per month in the US
Reimbursement Policies	Favorable post-approval, with growing use of companion diagnostics
Pricing Strategy	Tiered based on indication, healthcare setting, and market

Cost Considerations

Cost Item	Estimated Range (USD millions)	Notes
R&D Investment	USD 150–200 million/year	Ongoing clinical trials
Manufacturing & Supply Chain	Variable	Scale-up costs impact margins
Regulatory & Marketing	USD 50–80 million/year	Especially in emerging markets

Financial Risks and Opportunities

Risk Factors	Impact	Mitigation Strategy
Patent expiration or legal challenges	Loss of exclusivity, price competition	Portfolio diversification, pipeline pipeline diversification
Regulatory delays	Revenue stagnation	Proactive engagement with agencies
Market competition	Reduced market share	Differentiation through new indications

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Market Entry and Expansion Strategies

Key Opportunities

• Adjuvant and neoadjuvant settings in breast cancer: Potential approval could significantly increase revenues.
• New indication approvals (ovarian, prostate, pancreatic): Expand patient base.
• Combination therapies: Integration with immunotherapies or chemotherapies.
• Biomarker-driven precision medicine: Improving patient selection accuracy.

Barriers to Entry

• Patent landscapes: Navigating patent expiration timelines.
• Pricing and reimbursement landscapes: Secure favorable payer agreements.
• Clinical trial costs: High investments required for expanding approvals.

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Comparative Analysis

Dimension	Talazoparib (Pfizer)	Olaparib (AstraZeneca)	Niraparib (GSK)	Rucaparib (Clovis)
Approval Year	2018	2014	2017	2018
Indications	Breast, ovarian (expanding)	Breast, ovarian, prostate	Ovarian, breast	Ovarian, prostate
Efficacy (ORR)	High in BRCA-mutated cancers	Comparable	Similar	Similar
Adverse Events	Hematologic toxicity	Hematologic, GI	Hematologic, fatigue	Hematologic
Pricing (US)	USD 10,000–12,000/month	Similar	Similar	Similar

Note: Ongoing head-to-head studies and real-world data will influence future positioning.

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Future Outlook and Strategic Recommendations

• Accelerate pipeline development, focusing on first-line and early-stage indications.
• Expand diagnostic deployment for better patient stratification.
• Engage with payers early to establish favorable reimbursement pathways.
• Monitor patent expiries and prepare for generic entry post-2030.
• Invest in combination therapy trials to stay ahead in the competitive landscape.

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Key Takeaways

• Talazoparib's market potential remains robust with projected peak sales of USD 4.5 billion by 2028.
• Market growth is driven by increasing BRCA mutation prevalence, regulatory expansion, and personalized medicine trends.
• Competitive positioning depends on pipeline success, indication expansion, and pricing strategies.
• Pfizer retains strong IP protection until approximately 2030, offering near-term exclusivity.
• Investment in new indications, combination therapies, and biomarker strategies could significantly enhance long-term revenues.

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FAQs

1. What are the primary drivers for Talazoparib's market growth?

The main drivers include increasing detection of BRCA mutations, expanded indications to earlier and broader lines of therapy, supportive regulatory approvals, and growing use of companion diagnostics.

2. How does Talazoparib compare to other PARP inhibitors?

Talazoparib is regarded as highly potent with a strong efficacy profile, particularly for BRCA-mutated breast cancer. It faces competition from olaparib, niraparib, and rucaparib, each with comparable efficacy but different side effect profiles, prices, and approved indications.

3. What are the major risks associated with investing in Talazoparib?

Key risks include patent expiry, market competition, regulatory hurdles, adverse event management, and potential delays in indication expansions.

4. What is the outlook for pipeline-driven growth for Talazoparib?

Pipeline expansion into earlier-stage cancers and combination therapies holds significant promise, potentially doubling market size if approvals are secured.

5. How will healthcare payers influence Talazoparib's market success?

Reimbursement policies and pricing negotiations are crucial; favorable agreements can facilitate broader access and adoption, boosting sales.

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References

[1] Grand View Research, “PARP Inhibitors Market Size, Share & Trends Analysis Report by Compound, by Application, by Region, and Segment Forecasts, 2022-2028,” 2022.