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Last Updated: March 19, 2024

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*:
Constraining patent/regulatory exclusivity:
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:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Oct 2, 2018TE: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:⤷  Try a TrialPatent Expiration:Aug 3, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SUBJECTS HAVING BACTERIAL SKIN OR SKIN STRUCTURE INFECTION

Expired US Patents for NDA 209816

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

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