Details for New Drug Application (NDA): 209817
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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 209817
Tradename: | NUZYRA |
Applicant: | Paratek Pharms Inc |
Ingredient: | omadacycline tosylate |
Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209817
Generic Entry Date for 209817*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
POWDER;INTRAVENOUS |
*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: 209817
Suppliers and Packaging for NDA: 209817
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817 | NDA | Paratek Pharmaceuticals, Inc. | 71715-001 | 71715-001-02 | 10 VIAL, GLASS in 1 CARTON (71715-001-02) / 10 mL in 1 VIAL, GLASS (71715-001-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 100MG BASE/VIAL | ||||
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: | Mar 5, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTION |
Expired US Patents for NDA 209817
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Paratek Pharms Inc | NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817-001 | Oct 2, 2018 | ⤷ Sign Up | ⤷ Sign Up |
Paratek Pharms Inc | NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817-001 | Oct 2, 2018 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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