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Last Updated: October 21, 2019

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Poly(ADP-Ribose) Polymerase Inhibitor Drug Class List

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Drugs in Drug Class: Poly(ADP-Ribose) Polymerase Inhibitor

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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
Tesaro Inc	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Tesaro Inc	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		RX	Yes	Yes	Start Trial	Start Trial		Y		Start Trial
Tesaro Inc	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Tesaro Inc	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Pfizer Inc	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No	Start Trial	Start Trial	Y	Y		Start Trial
Pfizer Inc	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-002	Oct 16, 2018		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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