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:	310
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

Constraining patent/regulatory exclusivity:

8,735,392

NDA:

211651

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

8,735,392

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.

This potential generic entry date is based on patent 8,735,392.

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	9,820,985
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		DISCN	Yes	No	9,820,985
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-006	Jun 20, 2023		DISCN	Yes	No	8,735,392		Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-004	Mar 7, 2024		RX	Yes	No	9,820,985
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-005	Mar 7, 2024		RX	Yes	No	10,780,088

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
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 TALZENNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	CA 2019 00055	Denmark		PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT; REG. NO/DATE: EU/1/19/1377 20190624
2767537	301021	Netherlands		PRODUCT NAME: TALAZOPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1377 20190624
2767537	PA2019522	Lithuania		PRODUCT NAME: TALAZOPARIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1377 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	2019C/551	Belgium		PRODUCT NAME: TALAZOPARIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624

TALZENNA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

TALZENNA (talazoparib), a poly (ADP-ribose) polymerase (PARP) inhibitor developed by Pfizer Inc., targets specific genetic mutations, primarily BRCA1/2, in various cancer types. Its market entry and subsequent performance are influenced by clinical efficacy, regulatory approvals, competitive landscape, and payer reimbursement policies.

What is TALZENNA's approved indication and mechanism of action?

TALZENNA is approved for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer [1]. It is also indicated for adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic castration-resistant prostate cancer (mCRPC) [2].

The drug functions by inhibiting PARP enzymes, which are crucial for DNA repair. In cancer cells with deficiencies in DNA repair pathways, such as those with BRCA mutations, PARP inhibition leads to the accumulation of DNA damage and subsequent cell death [3]. This concept is known as synthetic lethality.

What is TALZENNA's current market status and competitive landscape?

TALZENNA competes within the PARP inhibitor class and the broader oncology market. Key competitors include:

• Olaparib (LYNPARZA) by AstraZeneca/Merck: A well-established PARP inhibitor with multiple approved indications across ovarian, breast, prostate, and pancreatic cancers. LYNPARZA has a significant market share due to its earlier entry and broader label.
• Niraparib (ZEJULA) by GlaxoSmithKline: Primarily approved for ovarian cancer, with ongoing research for other indications.
• Rucaparib (RUBRACA) by Clovis Oncology: Approved for BRCA-mutated ovarian cancer and prostate cancer.

The market for PARP inhibitors is characterized by increasing competition and ongoing clinical development to expand indications. The presence of other approved PARP inhibitors necessitates clear differentiation in efficacy, safety, and patient population for TALZENNA to maintain and grow its market share.

What are TALZENNA's key clinical trial results and regulatory approvals?

TALZENNA's approvals are based on pivotal clinical trials demonstrating its efficacy.

• Breast Cancer Indication: The U.S. Food and Drug Administration (FDA) approval for HER2-negative locally advanced or metastatic breast cancer was based on the EMBRACA trial. This Phase 3 study demonstrated a significant improvement in progression-free survival (PFS) compared to physician's choice of chemotherapy [1].
  • Median Progression-Free Survival (PFS): 22.0 months for TALZENNA vs. 4.6 months for chemotherapy.
  • Objective Response Rate (ORR): 62.6% for TALZENNA vs. 27.2% for chemotherapy.
• Prostate Cancer Indication: The FDA approval for mCRPC was based on the TALAPRO-2 study. This trial showed improved radiographic progression-free survival (rPFS) and overall survival (OS) when TALZENNA was combined with enzalutamide compared to enzalutamide alone in patients with gBRCAm metastatic castration-resistant prostate cancer [2].
  • Median rPFS (TALZENNA + enzalutamide vs. placebo + enzalutamide): Not reached vs. 16.6 months.
  • Median OS (TALZENNA + enzalutamide vs. placebo + enzalutamide): Not reached vs. 18.5 months.

Regulatory approvals have been granted by major agencies including the FDA in the United States and the European Medicines Agency (EMA) in Europe.

What is TALZENNA's sales performance and financial trajectory?

Pfizer reported net sales for TALZENNA. The financial performance is directly correlated with prescription volumes, pricing, and market access.

• 2022 Net Sales: $299 million [4].
• 2023 Net Sales: $377 million [5].
• Year-over-year Growth (2022-2023): Approximately 26% [4, 5].

The sales trajectory indicates steady growth, driven by its approved indications and increasing physician and patient uptake. Future financial performance will depend on:

• Expansion into new indications: Ongoing clinical trials exploring TALZENNA in other cancer types or earlier lines of therapy could significantly boost sales.
• Geographic expansion: Further market penetration in emerging and established markets.
• Pricing and reimbursement: Maintaining favorable reimbursement from payers.
• Competition: The impact of new entrants or expanded labels of existing competitors.

Pfizer's strategy likely involves leveraging TALZENNA in combination therapies and seeking label expansions to solidify its market position.

What are the key challenges and opportunities for TALZENNA?

Challenges:

• Intense Competition: The PARP inhibitor market is crowded with established players like LYNPARZA. Differentiation is critical.
• Market Access and Reimbursement: Securing and maintaining favorable reimbursement from payers can be challenging, especially with rising healthcare costs and the introduction of multiple treatment options.
• Patient Identification: Accurately identifying patients with specific genetic mutations (gBRCAm) requires robust diagnostic infrastructure and physician awareness.
• Adverse Event Management: PARP inhibitors can have associated toxicities, requiring careful patient monitoring and management by healthcare providers.

Opportunities:

• Combination Therapies: Investigating TALZENNA in combination with other oncology agents, such as checkpoint inhibitors or chemotherapy, could expand its efficacy and market reach.
• New Indications: Pursuing approvals in other solid tumors or hematological malignancies where PARP inhibition has shown promise.
• Biomarker Exploration: Identifying additional biomarkers that predict response to TALZENNA could broaden its applicability.
• Geographic Expansion: Increasing access in underserved or emerging markets.

The company's focus on real-world evidence generation and patient support programs will also be critical for sustained market success.

Key Takeaways

• TALZENNA is a PARP inhibitor approved for BRCA-mutated breast and prostate cancers.
• Its mechanism of action relies on synthetic lethality, exploiting DNA repair deficiencies in cancer cells.
• The drug faces significant competition from other PARP inhibitors, notably LYNPARZA.
• TALZENNA has demonstrated strong efficacy in pivotal trials, leading to its regulatory approvals.
• Net sales have shown consistent growth, reaching $377 million in 2023, with a 26% increase from 2022.
• Future growth hinges on expanding indications, exploring combination therapies, and navigating market access challenges.

FAQs

1. What is the primary genetic target for TALZENNA? TALZENNA targets mutations in BRCA1 and BRCA2 genes.
2. What are the main adverse events associated with TALZENNA? Common adverse events include anemia, neutropenia, thrombocytopenia, and fatigue.
3. Is TALZENNA approved for use in combination with other therapies? Yes, TALZENNA is approved in combination with enzalutamide for certain prostate cancer patients. It is also being investigated in combination with other agents in ongoing clinical trials.
4. What is the expected market growth rate for PARP inhibitors? The PARP inhibitor market is projected to experience significant growth, driven by expanding indications and increased diagnosis of relevant genetic mutations, though specific growth rates vary by forecast.
5. How does TALZENNA differentiate itself from other PARP inhibitors like LYNPARZA? Differentiation is primarily based on specific clinical trial data supporting distinct indications, efficacy profiles in particular patient subgroups, and potentially safety profiles.

Citations

[1] U.S. Food and Drug Administration. (2018). FDA approves talazoparib for patients with germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. [Press release]. [2] Pfizer Inc. (2023). Pfizer’s TALZENNA® (talazoparib) Significantly Improves Radiographic Progression-Free Survival and Overall Survival in Landmark TALAPRO-2 Study in Combination with Enzalutamide for Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Germline BRCA Mutations. [Press release]. [3] Drew, Y., Sharma, R., & o'Connor, M. J. (2014). The synthetic lethality of poly(ADP-ribose) polymerase inhibition: its role in cancer treatment and the development of resistance. Genes & Development, 28(18), 1980-1991. [4] Pfizer Inc. (2023). Pfizer Reports Fourth Quarter and Full-Year 2022 Results. Annual Report. [5] Pfizer Inc. (2024). Pfizer Reports Fourth Quarter and Full-Year 2023 Results. Annual Report.

DrugChatter Q&A for TALZENNA

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