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TALZENNA Drug Patent Profile

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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-five patent family members in thirty-one 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

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Summary for TALZENNA

International Patents:	95
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	23
Patent Applications:	563
Drug Prices:	Drug price information for TALZENNA
What excipients (inactive ingredients) are in TALZENNA?	TALZENNA excipients list
DailyMed Link:	TALZENNA at DailyMed

Drug patent expirations by year for TALZENNA

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

Generic Entry Dates for TALZENNA^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe NDA: 211651 Dosage: CAPSULE;ORAL
Generic Entry Dates for TALZENNA^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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
Hospital Sultan Ismail	Phase 2
University of Malaya	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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TALZENNA is ⤷ Subscribe.

This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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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	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-006	Jun 20, 2023		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

Patent: 3502
Patent: 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
Estimated Expiration: ⤷ Subscribe

Australia

Patent: 11317040
Patent: 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
Estimated Expiration: ⤷ Subscribe

Patent: 17201564
Patent: 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
Estimated Expiration: ⤷ Subscribe

Brazil

Patent: 2013009117
Patent: 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.
Estimated Expiration: ⤷ Subscribe

Canada

Patent: 14581
Patent: 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)
Estimated Expiration: ⤷ Subscribe

China

Patent: 3282365
Patent: Crystalline (8S,9R)--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
Estimated Expiration: ⤷ Subscribe

Cyprus

Patent: 23356
Estimated Expiration: ⤷ Subscribe

Denmark

Patent: 30146
Estimated Expiration: ⤷ Subscribe

European Patent Office

Patent: 30146
Patent: SEL TOSYLATE DE LA (8S,9R)-5-FLUORO-8-(4-FLUOROPHÉNYL)-9-(1-MÉTHYL-1H- 1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTALAZIN-3(7H)-ONE CRISTALLIN (CRYSTALINE (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 TOSYLATE SALT)
Estimated Expiration: ⤷ Subscribe

Patent: 57106
Patent: SEL TOSYLATE DE LA (8S,9R)-5-FLUORO-8-(4-FLUOROPHÉNYL)-9-(1-MÉTHYL-1H- 1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTALAZIN-3(7H)-ONE CRISTALLIN (CRYSTALINE (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 TOSYLATE SALT)
Estimated Expiration: ⤷ Subscribe

Hungary

Patent: 51535
Estimated Expiration: ⤷ Subscribe

Israel

Patent: 5789
Patent: מלח טוזילאט של (5-(9r, 8s-פלואורו-8-(4-פלואורופניל)-9-(1-מתיל-4,2,1-1h- טריאזול-5-יל)- 9,8- דיהידרו-2h-פירידו[2,3,4-דה] פתאלאזינ-3(3h)-און גבישי (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)
Estimated Expiration: ⤷ Subscribe

Patent: 1497
Patent: מלח טוזילאט של (s8, r9)-5-פלואורו-8-(4-פלואורופניל)-9-(1-מתיל-h1- 4,2,1-טריאזול-5-יל)-9,8-דיהידרו-h2-פירידו[2,3,4-דה]פתאלאזינ-3(h3)-און גבישי (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)
Estimated Expiration: ⤷ Subscribe

Japan

Patent: 13540158
Estimated Expiration: ⤷ Subscribe

Patent: 17061526
Patent: 結晶性（８Ｓ，９Ｒ）−５−フルオロ−８−（４−フルオロフェニル）−９−（１−メチル−１Ｈ−１，２，４−トリアゾール−５−イル）−８，９−ジヒドロ−２Ｈ−ピリド［４，３，２−ｄｅ］フタラジン−３（７Ｈ）−オントシレート塩 (CRYSTALINE (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)
Estimated Expiration: ⤷ Subscribe

Patent: 19034951
Patent: 結晶性（８Ｓ，９Ｒ）−５−フルオロ−８−（４−フルオロフェニル）−９−（１−メチル−１Ｈ−１，２，４−トリアゾール−５−イル）−８，９−ジヒドロ−２Ｈ−ピリド［４，３，２−ｄｅ］フタラジン−３（７Ｈ）−オントシレート塩 (CRYSTALLINE (8S,9R)-5-FLUORO-8-(4-FLUOROPHENYL)-9-(1-METHYL-1H-1,2,4-TRIAZOLE-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTHALAZINE-3(7H)-ON TOSYLATE)
Estimated Expiration: ⤷ Subscribe

Patent: 20169209
Patent: 結晶性（８Ｓ，９Ｒ）−５−フルオロ−８−（４−フルオロフェニル）−９−（１−メチル−１Ｈ−１，２，４−トリアゾール−５−イル）−８，９−ジヒドロ−２Ｈ−ピリド［４，３，２−ｄｅ］フタラジン−３（７Ｈ）−オントシレート塩 (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)
Estimated Expiration: ⤷ Subscribe

Patent: 22140637
Patent: 結晶性（８Ｓ，９Ｒ）－５－フルオロ－８－（４－フルオロフェニル）－９－（１－メチル－１Ｈ－１，２，４－トリアゾール－５－イル）－８，９－ジヒドロ－２Ｈ－ピリド［４，３，２－ｄｅ］フタラジン－３（７Ｈ）－オントシレート塩
Estimated Expiration: ⤷ Subscribe

Mexico

Patent: 2563
Patent: SAL TOSILATO 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. (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]P HTHALAZIN-3(7H)-ONE TOSYLATE SALT.)
Estimated Expiration: ⤷ Subscribe

Patent: 13004195
Patent: SAL TOSILATO 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. (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]P HTHALAZIN-3(7H)-ONE TOSYLATE SALT.)
Estimated Expiration: ⤷ Subscribe

New Zealand

Patent: 9490
Patent: 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
Estimated Expiration: ⤷ Subscribe

Poland

Patent: 30146
Estimated Expiration: ⤷ Subscribe

Portugal

Patent: 30146
Estimated Expiration: ⤷ Subscribe

Russian Federation

Patent: 98606
Patent: КРИСТАЛЛИЧЕСКАЯ ТОЗИЛАТНАЯ СОЛЬ (8S,9R)-5-ФТОР-8-(4-ФТОРФЕНИЛ)-9-(1-МЕТИЛ-1Н-1,2,4-ТРИАЗОЛ-5-ИЛ)-8-9-ДИГИДРО-2Н-ПИРИДО[4,3,2-de]ФТАЛАЗИН-3(7Н)-ОНА (CRYSTALLINE TOSYLATE SALT (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)
Estimated Expiration: ⤷ Subscribe

Patent: 13123036
Patent: КРИСТАЛЛИЧЕСКАЯ ТОЗИЛАТНАЯ СОЛЬ (8S,9R)-5-ФТОР-8-(4-ФТОРФЕНИЛ)-9-(1-МЕТИЛ-1Н-1,2,4-ТРИАЗОЛ-5-ИЛ)-8-9-ДИГИДРО-2Н-ПИРИДО[4,3,2-de]ФТАЛАЗИН-3(7Н)-ОНА
Estimated Expiration: ⤷ Subscribe

Singapore

Patent: 9939
Patent: 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
Estimated Expiration: ⤷ Subscribe

Patent: 201710578T
Patent: 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
Estimated Expiration: ⤷ Subscribe

Slovenia

Patent: 30146
Estimated Expiration: ⤷ Subscribe

South Africa

Patent: 1302810
Patent: CRYSTALLINE(8S,9R)-5-FLUORO-8-(4-FLUOROPHENYL)-9-(1-METHYL-1H11,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTHALAZIN-3(7H)-ONE TOSYLATE SALT
Estimated Expiration: ⤷ Subscribe

South Korea

Patent: 140009181
Patent: 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
Estimated Expiration: ⤷ Subscribe

Patent: 180069132
Patent: 결정질의 (8S,9R)-5-플루오로-8--9-(1-메틸-1H-1,2,4-트리아졸-5-일)-8,9-디하이드로-2H-피리도[4,3,2-DE]프탈라진-3(7H)-온 토실레이트 염 (8S9R-5--8-4--9-1--1H-124--5--89--2H-[432-DE]-37H- CRYSTALLINE 8S9R-5-FLUORO-8-4-FLUOROPHENYL-9-1-METHYL-1H-124-TRIAZOL-5-YL-89-DIHYDRO-2H-PYRIDO[432-DE]PHTHALAZIN-37H-ONE TOSYLATE SALT)
Estimated Expiration: ⤷ Subscribe

Patent: 190120458
Patent: 결정질의 (8S,9R)-5-플루오로-8--9-(1-메틸-1H-1,2,4-트리아졸-5-일)-8,9-디하이드로-2H-피리도[4,3,2-DE]프탈라진-3(7H)-온 토실레이트 염 (8S9R-5--8-4--9-1--1H-124--5--89--2H-[432-DE]-37H- CRYSTALLINE 8S9R-5-FLUORO-8-4-FLUOROPHENYL-9-1-METHYL-1H-124-TRIAZOL-5-YL-89-DIHYDRO-2H-PYRIDO[432-DE]PHTHALAZIN-37H-ONE TOSYLATE SALT)
Estimated Expiration: ⤷ Subscribe

Patent: 210028747
Patent: 결정질의 (8S,9R)-5-플루오로-8--9-(1-메틸-1H-1,2,4-트리아졸-5-일)-8,9-디하이드로-2H-피리도[4,3,2-DE]프탈라진-3(7H)-온 토실레이트 염 (8S9R-5--8-4--9-1--1H-124--5--89--2H-[432-DE]-37H- CRYSTALLINE 8S9R-5-FLUORO-8-4-FLUOROPHENYL-9-1-METHYL-1H-124-TRIAZOL-5-YL-89-DIHYDRO-2H-PYRIDO[432-DE]PHTHALAZIN-37H-ONE TOSYLATE SALT)
Estimated Expiration: ⤷ Subscribe

Spain

Patent: 16600
Estimated Expiration: ⤷ Subscribe

Taiwan

Patent: 57123
Estimated Expiration: ⤷ Subscribe

Patent: 43858
Estimated Expiration: ⤷ Subscribe

Patent: 1307345
Patent: 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
Estimated Expiration: ⤷ Subscribe

Patent: 1713656
Patent: 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
Estimated Expiration: ⤷ Subscribe

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.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3757106	SEL TOSYLATE DE LA (8S,9R)-5-FLUORO-8-(4-FLUOROPHÉNYL)-9-(1-MÉTHYL-1H- 1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTALAZIN-3(7H)-ONE CRISTALLIN (CRYSTALINE (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 TOSYLATE SALT)	⤷ Subscribe
Portugal	2767537		⤷ Subscribe
Lithuania	PA2019522		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TALZENNA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	CR 2019 00055	Denmark	⤷ Subscribe	PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT; REG. NO/DATE: EU/1/19/1377 20190624
2767537	C02767537/01	Switzerland	⤷ Subscribe	PRODUCT NAME: TALAZOPARIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67141 12.12.2019
2767537	LUC00140	Luxembourg	⤷ Subscribe	PRODUCT NAME: TALAZOPARIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

TALZENNA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TALZENNA

Overview of TALZENNA

TALZENNA, also known as talazoparib, is a prescription medicine developed by Pfizer, used to treat adults with a specific type of breast cancer, namely gBRCA-mutated, HER2-negative (HER2-) breast cancer that has spread to other parts of the body[4].

Clinical Efficacy and Market Position

Clinical Study Results

TALZENNA has demonstrated significant efficacy in clinical trials. In a study involving 431 patients with gBRCA-mutated, HER2- locally advanced or metastatic breast cancer, TALZENNA was found to be more effective at delaying disease progression compared to chemotherapy. The median time to disease progression was 8.6 months for patients on TALZENNA, compared to 5.6 months for those on chemotherapy. Additionally, TALZENNA reduced the risk of cancer progression by 46% and showed a tumor response rate of 50.2%, more than twice that of chemotherapy[4].

Market Opportunity

The PARP inhibitors market, which includes TALZENNA, is anticipated to experience substantial growth. This growth is driven by the label expansion of leading PARP inhibitors and their increasing use in treating various cancers, including breast, ovarian, and prostate cancers. The total market size of PARP inhibitors in the 7MM (seven major markets) is expected to surge significantly by 2034[3].

Financial Performance and Projections

Current Financials

Pfizer's financial reports indicate that while the company's overall revenues have been impacted by the decline in sales of COVID-19 related products like Comirnaty and Paxlovid, other segments, including biopharmaceuticals, have shown growth. Excluding contributions from Comirnaty and Paxlovid, Pfizer's revenues grew 7% operationally in 2023 and are expected to grow 8% to 10% operationally in 2024, including the impact of the Seagen acquisition[2][5].

Revenue Contribution

While specific revenue figures for TALZENNA are not detailed in Pfizer's recent earnings reports, the growth in the PARP inhibitors market and the clinical efficacy of TALZENNA suggest it is a significant contributor to Pfizer's biopharmaceutical revenues. For context, another PARP inhibitor, LYNPARZA, generated approximately $2.7 billion in revenue globally, with 40% of that revenue coming from the United States[3].

Market Dynamics

Competitive Landscape

The PARP inhibitors market is competitive, with several key players including AstraZeneca (LYNPARZA), GlaxoSmithKline (ZEJULA), and Pfizer (TALZENNA). The market is driven by the expansion of indications for these drugs and their increasing adoption in clinical practice. TALZENNA's strong clinical trial results and its specific indication for gBRCA-mutated breast cancer position it well in this competitive landscape[3][4].

Regulatory Environment

The regulatory environment for PARP inhibitors is favorable, with ongoing label expansions and approvals for new indications. This trend is expected to continue, driving growth in the market. For instance, the FDA's approval of TALZENNA for its specific indication has been a significant factor in its market presence[4].

Financial Trajectory

Cost Savings and Efficiency

Pfizer is implementing various cost-saving initiatives, including a manufacturing optimization program anticipated to save approximately $1.5 billion by the end of 2027. These efforts are expected to improve the company's operational efficiency and margin, which could positively impact the financial performance of drugs like TALZENNA[5].

Revenue Growth Projections

Excluding the contributions from COVID-19 related products, Pfizer expects operational revenue growth of 8% to 10% in 2024, which includes the impact of the Seagen acquisition. This growth is driven by key in-line products and recent commercial launches, including the potential contributions from TALZENNA and other biopharmaceutical products[2][5].

Key Takeaways

Clinical Efficacy: TALZENNA has shown significant clinical efficacy in treating gBRCA-mutated, HER2-negative breast cancer, delaying disease progression and reducing the risk of cancer growth.
Market Growth: The PARP inhibitors market is expected to experience substantial growth driven by label expansions and increasing adoption.
Financial Performance: Pfizer's biopharmaceutical segment, which includes TALZENNA, has shown operational revenue growth despite declines in COVID-19 related products.
Cost Savings: Pfizer's cost-saving initiatives are expected to improve operational efficiency and margins.
Regulatory Environment: Favorable regulatory approvals and ongoing label expansions support the market growth of PARP inhibitors.

FAQs

Q: What is TALZENNA used for?

TALZENNA is used to treat adults with a specific type of breast cancer, namely gBRCA-mutated, HER2-negative breast cancer that has spread to other parts of the body.

Q: How effective is TALZENNA compared to chemotherapy?

TALZENNA was found to be significantly more effective at delaying disease progression than chemotherapy, with a median time to disease progression of 8.6 months compared to 5.6 months for chemotherapy.

Q: What is the market outlook for PARP inhibitors?

The PARP inhibitors market is anticipated to experience substantial growth by 2034, driven by label expansions and increasing adoption in treating various cancers.

Q: How does Pfizer's financial performance impact TALZENNA?

Pfizer's overall financial performance, particularly in the biopharmaceutical segment, is expected to grow operationally, which includes the potential contributions from TALZENNA.

Q: What cost-saving initiatives is Pfizer implementing?

Pfizer is implementing a manufacturing optimization program anticipated to save approximately $1.5 billion by the end of 2027, among other cost-saving initiatives.

Sources

GlobalData: Net Present Value Model: Talzenna - GlobalData
Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance
PR Newswire: PARP Inhibitors Market to Register Immense Growth by 2034
Talzenna.com: Learn About TALZENNA® (talazoparib) | Safety Info
Pfizer: Pfizer Reports Strong Second-Quarter 2024 Results And Raises Full-Year Guidance

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Summary for TALZENNA

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

Recent Clinical Trials for TALZENNA

Pharmacology for TALZENNA

When does loss-of-exclusivity occur for TALZENNA?

TALZENNA Market Analysis and Financial Projection Experimental

Overview of TALZENNA

Clinical Efficacy and Market Position

Clinical Study Results

Market Opportunity

Financial Performance and Projections

Current Financials

Revenue Contribution

Market Dynamics

Competitive Landscape

Regulatory Environment

Financial Trajectory

Cost Savings and Efficiency

Revenue Growth Projections

Key Takeaways

FAQs

Q: What is TALZENNA used for?

Q: How effective is TALZENNA compared to chemotherapy?

Q: What is the market outlook for PARP inhibitors?

Q: How does Pfizer's financial performance impact TALZENNA?

Q: What cost-saving initiatives is Pfizer implementing?

Sources

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