TALZENNA Drug Patent Profile

When do Talzenna patents expire, and when can generic versions of Talzenna launch?

Talzenna is a drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this drug.

This drug has ninety-seven patent family members in thirty-two countries.

The generic ingredient in TALZENNA is talazoparib tosylate. Two suppliers are listed for this compound. Additional details are available on the talazoparib tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Talzenna

Talzenna was eligible for patent challenges on October 16, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 20, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TALZENNA

International Patents:	97
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	23
Patent Applications:	308
Drug Prices:	Drug price information for TALZENNA
What excipients (inactive ingredients) are in TALZENNA?	TALZENNA excipients list
DailyMed Link:	TALZENNA at DailyMed

See drug prices for TALZENNA

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

NDA:

211651

Dosage:

CAPSULE;ORAL

NDA:

217439

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 TALZENNA

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

Sponsor	Phase
German Cancer Research Center	Phase 1/Phase 2
University of Malaya	Phase 2
Cancer Research Malaysia	Phase 2

See all TALZENNA clinical trials

Pharmacology for TALZENNA

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

US Patents and Regulatory Information for TALZENNA

TALZENNA is protected by six US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	217439-006	Mar 7, 2024		RX	Yes	Yes
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		DISCN	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-006	Jun 20, 2023		DISCN	Yes	No			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-004	Mar 7, 2024		RX	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-005	Mar 7, 2024		RX	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		DISCN	Yes	No			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-004	Mar 7, 2024		RX	Yes	No			Y	Y

International Patents for TALZENNA

When does loss-of-exclusivity occur for TALZENNA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TALZENNA around the world.

Country	Patent Number	Title	Estimated Expiration
Luxembourg	C00140
Japan	2017061526
Portugal	2326650
Japan	2013540158
Taiwan	I643858
Lithuania	2767537
Israel	271497

Supplementary Protection Certificates for TALZENNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	756	Finland
2767537	SPC/GB19/070	United Kingdom		PRODUCT NAME: TALAZOPARIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, SUCH AS THE TOSYLATE SALT; REGISTERED: UK EU/1/19/1377 (NI) 20190624; UK PLGB00057-1672 20190624; UK PLGB00057-1673 20190624
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)
2767537	C201930072	Spain		PRODUCT NAME: TALAZOPARIB, OPCIONALMENTE EN FORMA DE SAL FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1377; DATE OF AUTHORISATION: 20190620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1377; DATE OF FIRST AUTHORISATION IN EEA: 20190620
2767537	LUC00140	Luxembourg		PRODUCT NAME: TALAZOPARIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624
2767537	2019042	Norway		PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTERBART SALT; REG. NO/DATE: EU/1/19/1377 20190715

Market Dynamics and Financial Trajectory for TALZENNA

Last updated: November 22, 2025

Introduction

TALZENNA (talazoparib), developed and marketed by Pfizer, is a first-in-class PARP inhibitor approved for the treatment of germline BRCA-mutated (gBRCAm) locally advanced or metastatic breast cancer. Since its FDA approval in 2018, TALZENNA's market performance exemplifies the evolving landscape of targeted cancer therapies, driven by expanding indications, competitive dynamics, and emerging biomarkers. This analysis elucidates the key market dynamics, financial trajectory, and strategic factors influencing TALZENNA’s commercial outlook.

Market Landscape and Therapeutic Positioning

1. Competitive Environment

TALZENNA operates within the PARP inhibitor class, alongside competitors such as AstraZeneca’s Lynparza (olaparib) and Merck's / Eisai’s Lynparza. Although Lynparza was first-to-market in several indications, TALZENNA's approval for specific breast cancer subsets distinguishes its niche. The PARP class remains vital for BRCA-mutated cancers, with ongoing trials expanding indications to ovarian, pancreatic, and prostate cancers.

Despite initial market entry hurdles, TALZENNA benefits from Pfizer’s established presence in oncology, robust clinical data, and targeted marketing strategies. However, the competitive pressure from Lynparza persists due to earlier market penetration and broader approved indications—factors influencing its revenue trajectory.

2. Expanding Indications and Clinical Development

The therapeutic potential of TALZENNA extends beyond breast cancer. Pfizer’s strategic expansion efforts include registration trials for ovarian (OlympiAD-2), pancreatic, and prostate cancers, anticipating broader label extensions. For instance, pivotal studies like Talzenna plus abiraterone for metastatic castration-resistant prostate cancer aim to bolster market penetration.

Success in these avenues hinges on clinical trial outcomes and regulatory approvals, which could significantly enhance the financial prospects of TALZENNA. The approval timeline for these indications remains pivotal for revenue acceleration.

3. Regulatory and Reimbursement Landscape

FDA approvals for TALZENNA are complemented by positive coverage decisions in key healthcare markets. Reimbursement remains critical; high drug costs necessitate favorable payer acceptance. Pfizer’s engagement with payers and demonstrated value through clinical data are essential for maintaining reimbursement levels conducive to sales growth.

Moreover, ongoing health technology assessments (HTAs) in Europe and Asia influence access, affecting the global sales trajectory. Rapid approval of supplementary indications and value-based pricing strategies will be instrumental for TALZENNA’s market expansion.

Financial Trajectory and Revenue Drivers

1. Revenue Streams and Growth Potential

Since launch, TALZENNA has demonstrated promising revenue growth, driven primarily by its initial approval for gBRCAm metastatic breast cancer. Sales milestones reached in 2021 and projections into 2023 reflect increased prescribing as clinicians adopt the drug in line with evolving guidelines.

Pfizer’s quarterly earnings reports indicate that TALZENNA’s revenue contribution is burgeoning, positioned as a high-margin asset owing to its targeted nature and premium pricing. The sales growth rate is expected to accelerate with indication expansions and increased awareness.

2. Key Revenue Drivers

• Indication Expansion: Additional approvals in ovarian and prostate cancers could exponentially increase patient eligible populations.
• Line of Therapy Adoption: TALZENNA is increasingly adopted as a first-line treatment in eligible patients, emphasizing early adoption's importance for revenue.
• Market Penetration: Geographic expansion into Europe, Asia, and emerging markets is vital, as these regions hold significant growth potential. Pfizer’s established delivery infrastructure facilitates access.

3. Competitive Pricing and Market Share

Pricing strategies will influence sales volumes and profitability. While PARP inhibitors generally command high prices (e.g., >$14,000/month for similar agents), payer negotiations and value-based agreements are critical for sustained market share. As clinical efficacy becomes more evident, Pfizer can leverage data to justify premium pricing, thus impacting revenue trajectories.

4. Clinical Trial Milestones and R&D Pipeline

Ongoing and future trials, such as combination regimens with immunotherapies and testing in earlier disease stages, could broaden TALZENNA’s use cases. Positive trial outcomes are likely to catalyze pipeline-driven revenue growth, especially if they lead to label extensions. Conversely, delays or adverse results could hinder anticipated growth.

Challenges and Risks Influencing Market Dynamics

1. Competition and Biosimilar Entry

The competitive landscape remains intense, with Lynparza maintaining a leading position in certain indications due to earlier market entry and wider approvals. Potential emergence of biosimilars or alternative treatments, especially with ongoing combination therapy research, could dilute market share.

2. Clinical and Regulatory Risks

While initial trials are promising, uncertainty persists around trial completion timelines and regulatory receptivity. Regulatory hurdles in certain jurisdictions and the need for post-marketing studies present risks.

3. Pricing and reimbursement pressures

Payers' increasing scrutiny over drug prices and cost-effectiveness evaluations could challenge revenue growth, particularly if cheaper alternatives emerge or if value-based pricing benchmarks tighten.

4. Patent and Market Exclusivity

Patent expirations or legal challenges threaten exclusivity, especially as biosimilars are developed globally. Such factors could impact future revenue streams.

Strategic Outlook and Future Trajectory

The future of TALZENNA hinges on its ability to expand into new indications and markets, maintain clinical momentum, and demonstrate comparative efficacy and safety. Pfizer’s robust pipeline and strategic investments in combination therapies position TALZENNA for sustained growth, contingent on successful clinical trials and appropriate regulatory approvals.

Furthermore, the integration of companion diagnostics and biomarker-driven patient selection will optimize market penetration and improve cost-effectiveness, enhancing commercial viability.

Anticipated Revenue Growth

• Near term (1-2 years): Focused on sales in breast cancer, leveraging existing label and prescriber familiarity.
• Medium term (3-5 years): Expansion into ovarian, prostate, and pancreatic cancers, combined with geographic growth.
• Long term (5+ years): Potential adoption in earlier treatment lines and combination regimens, potentially transforming TALZENNA into a cornerstone targeted therapy.

Market Penetration Strategy

Pfizer's strategic focus involves strengthening relationships with oncology specialists, integrating real-world evidence to support value proposition, and demonstrating clinical benefits over competitors. Collaboration with diagnostic providers to refine biomarker screening further enhances targeted patient selection.

Key Takeaways

• Market position: TALZENNA occupies a significant niche within the PARP inhibitor class, with room for expansion via label extensions and pipeline developments.
• Growth drivers: Indication expansion, early-line adoption, and international market penetration are primary catalysts.
• Competitive landscape: Lynparza remains the dominant player, but TALZENNA's differentiated approvals and clinical data support its growth trajectory.
• Financial outlook: Revenue is poised for substantial growth, contingent on successful clinical trials, regulatory approvals, and reimbursement strategies.
• Risks: Market competition, regulatory delays, pricing pressures, and patent challenges remain ongoing concerns.

Conclusion

TALZENNA’s financial trajectory underscores its potential as a pivotal targeted therapy within oncology. Strategic expansion, robust clinical validation, and market access will determine its growth sustainability amid intense competition. Pfizer’s ongoing investments and pipeline position TALZENNA as a promising asset with long-term revenue prospects in the evolving landscape of precision cancer therapies.

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Sources:

[1] FDA Approval Announcement — TALZENNA (2018).
[2] Pfizer Reports Q4 2022 Earnings — Oncology Revenue Details.
[3] ClinicalTrials.gov — Ongoing Trials of TALZENNA in Various Indications.
[4] EvaluatePharma — Oncology Market Size and Forecasts.
[5] IMS Health Data on Cancer Drug Reimbursement and Pricing Trends.