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Last Updated: July 4, 2020

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use
Vertex Pharms Inc	SYMDEKO (COPACKAGED)	ivacaftor; ivacaftor, tezacaftor	TABLET, TABLET;ORAL	210491-001	Feb 12, 2018		RX	Yes	Yes	Start Trial	Start Trial	Y	Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No	Start Trial	Start Trial		Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No	Start Trial	Start Trial				TREATMENT OF MARGINAL ZONE LYMPHOMA
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No	Start Trial	Start Trial				TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No	Start Trial	Start Trial		Y
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use

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