XERAVA Drug Patent Profile
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When do Xerava patents expire, and what generic alternatives are available?
Xerava is a drug marketed by Tetraphase Pharms and is included in one NDA. There are four patents protecting this drug.
This drug has eighty-four patent family members in thirty-three 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.
DrugPatentWatch® Generic Entry Outlook for Xerava
Xerava was eligible for patent challenges on August 27, 2022.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 19, 2037. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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- What is the 5 year forecast for XERAVA?
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Summary for XERAVA
| International Patents: | 84 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 27 |
| Clinical Trials: | 1 |
| Patent Applications: | 102 |
| Drug Prices: | Drug price information for XERAVA |
| What excipients (inactive ingredients) are in XERAVA? | XERAVA excipients list |
| DailyMed Link: | XERAVA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XERAVA
*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.
Recent Clinical Trials for XERAVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| West Virginia University | Phase 2 |
Pharmacology for XERAVA
| Drug Class | Tetracycline-class Antibacterial |
US Patents and Regulatory Information for XERAVA
XERAVA is protected by four US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XERAVA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting XERAVA
Crystalline forms of eravacycline
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
C7-fluoro substituted tetracycline compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS IN PATIENTS 18 YEARS OF AGE AND OLDER
C7-fluoro substituted tetracycline compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting XERAVA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Tetraphase Pharms | XERAVA | eravacycline dihydrochloride | POWDER;INTRAVENOUS | 211109-002 | Jun 3, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Tetraphase Pharms | XERAVA | eravacycline dihydrochloride | POWDER;INTRAVENOUS | 211109-001 | Aug 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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
When does loss-of-exclusivity occur for XERAVA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
China
Patent: 0582486
Patent: 艾若威四环素的结晶形式 (CRYSTALLINE FORMS OF ERAVACYCLINE)
Estimated Expiration: ⤷ Sign Up
Patent: 7903083
Patent: 艾若威四环素的结晶形式
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 29236
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 29236
Patent: FORMES CRISTALLINES DE L'ÉRAVACYCLINE (CRYSTALLINE FORMS OF ERAVACYCLINE)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 19531321
Patent: エラバサイクリンの結晶形
Estimated Expiration: ⤷ Sign Up
Patent: 22186979
Patent: エラバサイクリンの結晶形
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 567
Patent: FORMES CRISTALLINES DE L'ÉRAVACYCLINE
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 019500822
Patent: CRYSTALLINE FORMS OF ERAVACYCLINE
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201903327P
Patent: CRYSTALLINE FORMS OF ERAVACYCLINE
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2660864
Estimated Expiration: ⤷ Sign Up
Patent: 190065414
Patent: 에라바사이클린의 결정질 형태
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering XERAVA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3529236 | FORMES CRISTALLINES DE L'ÉRAVACYCLINE (CRYSTALLINE FORMS OF ERAVACYCLINE) | ⤷ Sign Up |
| Croatia | P20130928 | ⤷ Sign Up | |
| Hong Kong | 1193412 | -氟取代的四環素化合物 (C7-FLUORO SUBSTITUTED TETRACYCLINE COMPOUNDS C7-) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XERAVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2323972 | 2019C/511 | Belgium | ⤷ Sign Up | PRODUCT NAME: ERAVACYCLINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1312 20180924 |
| 2323972 | 1990014-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: ERAVACYCLINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1312 20180924 |
| 2323972 | 12/2019 | Austria | ⤷ Sign Up | 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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