Details for New Drug Application (NDA): 209816
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NDA 209816 describes NUZYRA, which is a drug marketed by Paratek Pharms and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the NUZYRA profile page.
The generic ingredient in NUZYRA is omadacycline tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the omadacycline tosylate profile page.
The generic ingredient in NUZYRA is omadacycline tosylate. There is one drug master file entry for this compound. 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 |
| Ingredient: | omadacycline tosylate |
| Patents: | 8 |
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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Oct 2, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 13, 2029 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF INFORMATION TO THE LABELING FROM A CLINICAL STUDY | ||||||||
| 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 | ||||||||
Expired US Patents for NDA 209816
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Paratek Pharms | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Paratek Pharms | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Paratek Pharms | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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