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XERAVA Drug Profile
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Which patents cover Xerava, and what generic alternatives are available?
Xerava is a drug marketed by Tetraphase Pharms and is included in one NDA. There are two patents protecting this drug.
This drug has sixty-nine patent family members in twenty-nine countries.
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.
US ANDA Litigation and Generic Entry Outlook for Xerava
Xerava will be eligible for patent challenges on August 27, 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 December 28, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XERAVA
| International Patents: | 69 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for XERAVA |
| DailyMed Link: | XERAVA at DailyMed |
Generic Entry Opportunity Date for XERAVA
Generic Entry Date for XERAVA*:
Constraining patent/regulatory exclusivity:
NDA:
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.
US Patents and Regulatory Information for XERAVA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tetraphase Pharms | XERAVA | eravacycline dihydrochloride | POWDER;INTRAVENOUS | 211109-001 | Aug 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Tetraphase Pharms | XERAVA | eravacycline dihydrochloride | POWDER;INTRAVENOUS | 211109-001 | Aug 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Tetraphase Pharms | XERAVA | eravacycline dihydrochloride | POWDER;INTRAVENOUS | 211109-001 | Aug 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Tetraphase Pharms | XERAVA | eravacycline dihydrochloride | POWDER;INTRAVENOUS | 211109-001 | Aug 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for XERAVA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Croatia | P20130928 | Start Trial |
| Slovenia | 2323972 | Start Trial |
| Japan | 5496202 | Start Trial |
| Portugal | 2682387 | Start Trial |
| Singapore | 10201806714P | Start Trial |
| Taiwan | 201538483 | Start Trial |
| Taiwan | 201429930 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XERAVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2323972 | LUC00107 | Luxembourg | Start Trial | PRODUCT NAME: XERAVA - ERAVACYLINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924 |
| 2323972 | 122019000024 | Germany | Start Trial | PRODUCT NAME: ERAVACYCLINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1312 20180920 |
| 2323972 | CA 2019 00009 | Denmark | Start Trial | PRODUCT NAME: ERAVACYCLIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1312 20180209 |
| 2323972 | CR 2019 00009 | Denmark | Start Trial | PRODUCT NAME: ERAVACYCLIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1312 20180209 |
| 2323972 | 2019C/511 | Belgium | Start Trial | PRODUCT NAME: ERAVACYCLINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924 |
| 2323972 | C20190009 00277 | Estonia | Start Trial | PRODUCT NAME: ERAVATSUEKLIIN;REG NO/DATE: EU/1/18/1312 24.09.2018 |
| 2323972 | 12/2019 | Austria | Start Trial | PRODUCT NAME: ERAVACYCLIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1312 (MITTEILUNG) 20180924 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
