TALAZOPARIB TOSYLATE - Generic Drug Details

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.

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

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.

Recent Clinical Trials for TALAZOPARIB TOSYLATE

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

Sponsor	Phase
Stanford University	Phase 2
Pfizer	Phase 1
Roswell Park Cancer Institute	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	211651-003	Sep 20, 2021		DISCN	Yes	No	10,189,837		Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		DISCN	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-004	Sep 20, 2021		DISCN	Yes	No	8,012,976		Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-004	Mar 7, 2024		RX	Yes	No	10,780,088
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		DISCN	Yes	No	8,735,392		Y	Y

International Patents for TALAZOPARIB TOSYLATE

Country	Patent Number	Title	Estimated Expiration
South Africa	201302810
Singapore	189939
World Intellectual Property Organization (WIPO)	2012054698
Japan	2017061526
Poland	2767537

Supplementary Protection Certificates for TALAZOPARIB TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	54/2019	Austria		PRODUCT NAME: TALAZOPARIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1377 (MITTEILUNG) 20190624
2767537	132019000000153	Italy		PRODUCT NAME: TALAZOPARIB(TALZENNA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1377, 20190624
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	PA2019522,C2767537	Lithuania		PRODUCT NAME: TALAZOPARIBAS; REGISTRATION NO/DATE: EU/1/19/1377 20190620
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: March 5, 2026

What is Talazoparib Tosylate?

Talazoparib Tosylate is an oral poly(ADP-ribose) polymerase (PARP) inhibitor developed primarily for treating cancers with defective BRCA1/2 genes, including ovarian and breast cancers. It received regulatory approval from the U.S. Food and Drug Administration (FDA) in October 2018 for adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCA-mutated) advanced ovarian cancer who have received at least three prior lines of chemotherapy[^1].

How does the current market landscape look?

Key players

Company	Product	Indications	Market Share (Estimated)
Pfizer	TALZENNA (talazoparib)	Breast, ovarian, pancreatic cancers	65% (dominant player)
AstraZeneca	Lynparza (olaparib)	Multiple indications across ovarian, breast, prostate, pancreatic	>30%
Clovis Oncology	Rubraca (rucaparib)	Ovarian, prostate cancers	4-5%

Market size estimates

The global PARP inhibitor market was valued at approximately USD 3.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 10-12% through 2030, reaching USD 8 billion or more[^2].

Market growth drivers

• Rising incidences of BRCA-mutated cancers
• Increasing approval of PARP inhibitors for new indications
• Expansion of clinical trials exploring combination therapies
• Advances in biomarker testing to identify eligible patients

Geographical distribution

North America dominates the market, accounting for roughly 50% of revenue, driven by high diagnosis rates and healthcare infrastructure[^3]. Europe follows, with emerging markets in Asia-Pacific contributing to annual growth.

What are the key regulatory and commercial milestones?

Year	Event	Impact
2018	FDA approval in ovarian cancer	First PARP inhibitor approved for this indication; set the stage for commercial sales
2020	Expanded indication for TALZENNA	Approved for early-stage breast cancer in germline BRCA-mutated HER2-negative cases
2022	New clinical trial data	Demonstrated efficacy in combining with immunotherapies, opening future revenue streams

Financial outlook

Revenue projections

Pfizer reports that TALZENNA generated approximately USD 250 million in sales during 2022. Analysts project sales to reach USD 700 million by 2026, driven by expansion into new cancer types and combination regimens.

Year	Estimated Revenue	Growth Rate
2022	USD 250 million	-
2023	USD 400 million	60%
2024	USD 550 million	37.5%
2025	USD 650 million	18.2%
2026	USD 700 million	7.7%

R&D and commercialization costs

Pfizer has invested over USD 1 billion in the development, regulatory, and commercialization processes since 2014. Ongoing costs are estimated at USD 200-300 million annually for further trials and market expansion activities.

Patent and exclusivity status

Patent protection for Talazoparib extends into the late 2030s, providing a quasi-exclusivity horizon that justifies pricing power and market share retention. Orphan drug designation in specific indications supports potential extended exclusivity.

Market challenges and risks

• Competition from other PARP inhibitors, notably Lynparza, which holds broader indications
• Price pressures from payers and healthcare systems
• The emergence of resistance mechanisms limiting long-term efficacy
• Clinical trial failures or delays impacting pipeline expansion

Conclusion

Talazoparib Tosylate stands amidst a rapidly expanding segment in oncology therapeutics. Pfizer's early market entry established a solid position, with growth fueled by indication expansion and combination therapy trials. The drug’s trajectory depends on sustained clinical success, regulatory approvals, and competitive positioning vis-à-vis other PARP inhibitors.

Key Takeaways

• The global PARP inhibitor market is expected to reach USD 8 billion by 2030, with talazoparib contributing a significant share.
• Pfizer leads sales, with an estimated USD 250 million sales in 2022; projections suggest continued growth through 2026.
• Competition intensifies from AstraZeneca’s Lynparza and others, requiring ongoing differentiation strategies.
• Patent life, regulatory approvals, and pipeline development remain critical to the drug’s financial trajectory.

FAQs

1. What factors most influence talazoparib’s market share?
Market share depends on clinical efficacy, approved indications, safety profile, reimbursement policies, and the competitiveness of other PARP inhibitors.

2. Are there upcoming regulatory decisions that could impact sales?
Yes, approvals for new indications and ongoing trials exploring combinations with immunotherapies could significantly boost future sales.

3. How does talazoparib compare pricing-wise?
Pricing varies by geographic region; in the U.S., the average wholesale price (AWP) per course exceeds USD 16,000, comparable to other PARP inhibitors.

4. What is the pipeline status for talazoparib?
Pfizer is testing talazoparib in combination with other therapies across multiple cancers, including pancreatic and prostate cancers, with several phase 2/3 trials ongoing.

5. What are the key risks for investors?
Delayed approvals, clinical setbacks, pricing pressures, and increasing competition pose risks to revenue stability.

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[1] U.S. Food and Drug Administration. (2018). FDA approves talazoparib for germline BRCA-mutated advanced ovarian cancer.
[2] MarketsandMarkets. (2023). PARP Inhibitors Market Forecast.
[3] IQVIA. (2022). Global Oncology Market Data.