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VABOMERE Drug Profile
» See Plans and Pricing
When do Vabomere patents expire, and what generic alternatives are available?
Vabomere is a drug marketed by Rempex Pharms and is included in one NDA. There are five patents protecting this drug.
This drug has forty-nine patent family members in twenty-six countries.
The generic ingredient in VABOMERE is meropenem; vaborbactam. There are thirty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meropenem; vaborbactam profile page.
DrugPatentWatch® Generic Entry Outlook for Vabomere
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 17, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VABOMERE
| International Patents: | 49 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VABOMERE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VABOMERE |
| What excipients (inactive ingredients) are in VABOMERE? | VABOMERE excipients list |
| DailyMed Link: | VABOMERE at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for VABOMERE
Generic Entry Date for VABOMERE*:
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.
Recent Clinical Trials for VABOMERE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) | Phase 1 |
| Biomedical Advanced Research and Development Authority | Phase 1 |
Pharmacology for VABOMERE
| Drug Class | beta Lactamase Inhibitor Penem Antibacterial |
| Mechanism of Action | beta Lactamase Inhibitors |
US Patents and Regulatory Information for VABOMERE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rempex Pharms | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Rempex Pharms | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Rempex Pharms | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Rempex Pharms | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Rempex Pharms | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | 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 VABOMERE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2603514 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2013184845 | Start Trial |
| Mexico | 2013001517 | Start Trial |
| South Korea | 101987091 | Start Trial |
| Hungary | S1900018 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VABOMERE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2603514 | C201930022 | Spain | Start Trial | PRODUCT NAME: COMBINACION DE VABORBACTAM, Y/O UNA SAL Y/O UN HIDRATO DEL MISMO, Y MEROPENEM, Y/O UNA SAL Y/O UN HIDRATO DEL MISMO, EN PARTICULAR MEROPENM TRIHIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1334; DATE OF AUTHORISATION: 20181120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1334; DATE OF FIRST AUTHORISATION IN EEA: 20181120 |
| 2603514 | 2019/017 | Ireland | Start Trial | PRODUCT NAME: VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF; AUTHORISATION NO/DATE: EU/1/18/1334 20181120 |
| 2603514 | CA 2019 00016 | Denmark | Start Trial | PRODUCT NAME: VABORBACTAM, OG/ELLER ET SALT OG/ELLER HYDRAT HERAF; REG. NO/DATE: EU/1/18/1334 20181122 |
| 2603514 | C201930023 | Spain | Start Trial | PRODUCT NAME: VABORBACTAM, Y/O UNA SAL Y/O UN HIDRATO DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1334; DATE OF AUTHORISATION: 20181120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1334; DATE OF FIRST AUTHORISATION IN EEA: 20181120 |
| 2603514 | 300977 | Netherlands | Start Trial | PRODUCT NAME: EEN COMBINATIE VAN VABORBACTAM, EN/OF EEN ZOUT EN/OF EEN HYDRAAT DAARVAN, EN MEROPENEM, EN/OF EEN ZOUT EN/OF EEN HYDRAAT DAARVAN, IN HET BIJZONDER MEROPENEM TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/18/1334 20181122 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
