DrugPatentWatch Alpha Signals Regulatory Exclusivity

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Drug Search Regulatory Exclusivity

Regulatory Exclusivity: New Chemical Entity

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Drugs with New Chemical Entity Regulatory Exclusivity

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes	⤷ Get Started Free	NEW CHEMICAL ENTITY
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes	⤷ Get Started Free	NEW CHEMICAL ENTITY
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776-001	Aug 29, 2017		RX	Yes	Yes	⤷ Get Started Free	NEW CHEMICAL ENTITY
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

Regulatory Exclusivity

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Competitive Generic Therapy
New Chemical Entity
New Dosing Schedule
New Indication
New Product
New Patient Population
New Strength
Orphan Drug
Patent Challenge
Pediatric Exclusivity
RX to OTC Switch

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