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NUZYRA Drug Profile

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When do Nuzyra patents expire, and when can generic versions of Nuzyra launch?

Nuzyra is a drug marketed by Paratek Pharms Inc and is included in two NDAs. There are ten patents protecting this drug.

This drug has two hundred and eight patent family members in forty countries.

The generic ingredient in NUZYRA is omadacycline tosylate. Additional details are available on the omadacycline tosylate profile page.

US ANDA Litigation and Generic Entry Outlook for Nuzyra

Nuzyra will be eligible for patent challenges on October 2, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 2, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NUZYRA

International Patents:	208
US Patents:	10
Applicants:	1
NDAs:	2
Clinical Trials:	2
Drug Prices:	Drug price information for NUZYRA
DailyMed Link:	NUZYRA at DailyMed

See drug prices for NUZYRA

Generic Entry Opportunity Date for NUZYRA

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

209817

Dosage:

POWDER;INTRAVENOUS

NDA:

209816

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.

Recent Clinical Trials for NUZYRA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Paratek Pharmaceuticals Inc	Phase 1
Hartford Hospital	Phase 1
Paratek Pharmaceuticals Inc	Phase 2

See all NUZYRA clinical trials

US Patents and Regulatory Information for NUZYRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes			Y
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes			Y
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes				Y
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes				Y

International Patents for NUZYRA

Country	Patent Number	Estimated Expiration
Croatia	P20180836
Australia	2017353588
Denmark	1679305
Taiwan	I299038
Taiwan	201821082
Singapore	10201913599R
Slovenia	2271348