Details for New Drug Application (NDA): 209816

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NDA 209816 describes NUZYRA, which is a drug marketed by Paratek Pharms Inc and is included in two NDAs. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the NUZYRA profile page.

The generic ingredient in NUZYRA is omadacycline tosylate. One supplier is listed for this compound. Additional details are available on the omadacycline tosylate profile page.

Summary for 209816

Tradename:	NUZYRA
Applicant:	Paratek Pharms Inc
Ingredient:	omadacycline tosylate
Patents:	9

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209816

Generic Entry Date for 209816^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 209816

Suppliers and Packaging for NDA: 209816

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NUZYRA	omadacycline tosylate	TABLET;ORAL	209816	NDA	Paratek Pharmaceuticals, Inc.	71715-002	71715-002-21	1 BLISTER PACK in 1 CARTON (71715-002-21) / 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28)
NUZYRA	omadacycline tosylate	TABLET;ORAL	209816	NDA	Paratek Pharmaceuticals, Inc.	71715-002	71715-002-27	5 BLISTER PACK in 1 CARTON (71715-002-27) / 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Oct 2, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 2, 2028
Regulatory Exclusivity Use:	GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:	Oct 2, 2023
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	⤷ Sign Up	Patent Expiration:	Aug 3, 2037	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF SUBJECTS HAVING BACTERIAL SKIN OR SKIN STRUCTURE INFECTION

Expired US Patents for NDA 209816

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018	⤷ Sign Up	⤷ Sign Up
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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