Question 1

Is there a generic for Talazoparib tosylate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Talazoparib tosylate. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Talazoparib tosylate?

Accepted Answer

TALZENNA (NDA 217439, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Talazoparib tosylate?

Accepted Answer

The Orange Book lists 6 patents against Talazoparib tosylate products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Talazoparib tosylate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 6 marketing-exclusivity periods for Talazoparib tosylate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Talazoparib tosylate are approved?

Accepted Answer

Talazoparib tosylate is approved in the following dosage form: capsule.

Product	Applicant	Application	TE	Approved
TALZENNARLD×6	PFIZER	NDA 217439	—	Mar 07, 2024
TALZENNARLD×6	PFIZER	NDA 211651	—	Jun 20, 2023

Patent	Expires	In	Type
9820985	Jul 27, 2029	in 3 yr 2 mo	U-2437
10780088	Jul 27, 2029	in 3 yr 2 mo	U-3651
8012976	Jul 27, 2029	in 3 yr 2 mo	SubstanceProduct
8420650	Jul 27, 2029	in 3 yr 2 mo	SubstanceProduct
10189837	Oct 20, 2031	in 5 yr 5 mo	SubstanceProduct
8735392	Oct 20, 2031	in 5 yr 5 mo	SubstanceProduct

Talazoparib tosylate

Brand (NDA) products · capsule

Marketing exclusivity (6)

Listed patents (6)

Talazoparib tosylate — frequently asked questions

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