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Last Updated: September 18, 2020

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Regulatory Exclusivity Expiring in 2028

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Drugs with Regulatory Exclusivity Expiring in 2028

Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes	Start Trial	GENERATING ANTIBIOTIC INCENTIVES NOW
Tetraphase Pharms	XERAVA	eravacycline dihydrochloride	POWDER;INTRAVENOUS	211109-001	Aug 27, 2018		RX	Yes	Yes	Start Trial	GENERATING ANTIBIOTIC INCENTIVES NOW
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	Start Trial	GENERATING ANTIBIOTIC INCENTIVES NOW
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes	Start Trial	GENERATING ANTIBIOTIC INCENTIVES NOW
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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