Details for New Drug Application (NDA): 211109
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NDA 211109 describes XERAVA, which is a drug marketed by Tetraphase Pharms and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the XERAVA profile page.
The generic ingredient in XERAVA is eravacycline dihydrochloride. One supplier is listed for this compound. Additional details are available on the eravacycline dihydrochloride profile page.
The generic ingredient in XERAVA is eravacycline dihydrochloride. One supplier is listed for this compound. Additional details are available on the eravacycline dihydrochloride profile page.
Summary for 211109
| Tradename: | XERAVA |
| Applicant: | Tetraphase Pharms |
| Ingredient: | eravacycline dihydrochloride |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211109
Generic Entry Date for 211109*:
Constraining patent/regulatory exclusivity:
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: 211109
Suppliers and Packaging for NDA: 211109
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XERAVA | eravacycline dihydrochloride | POWDER;INTRAVENOUS | 211109 | NDA | Tetraphase Pharmaceuticals, Inc. | 71773-050 | 71773-050-05 | 1 VIAL, GLASS in 1 CARTON (71773-050-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| XERAVA | eravacycline dihydrochloride | POWDER;INTRAVENOUS | 211109 | NDA | Tetraphase Pharmaceuticals, Inc. | 71773-050 | 71773-050-12 | 12 VIAL, GLASS in 1 CARTON (71773-050-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Aug 27, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 27, 2028 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Aug 27, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,961,190 | Patent Expiration: | Oct 19, 2037 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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