VABOMERE Drug Patent Profile
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When do Vabomere patents expire, and what generic alternatives are available?
Vabomere is a drug marketed by Rempex and is included in one NDA. There are seven patents protecting this drug.
This drug has seventy patent family members in thirty 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
Vabomere was eligible for patent challenges on August 29, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 29, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VABOMERE
International Patents: | 70 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 4 |
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 Loss of Exclusivity (LOE) 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 |
---|---|
Biomedical Advanced Research and Development Authority | Phase 1 |
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) | Phase 1 |
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) | Phase 1 |
Pharmacology for VABOMERE
Drug Class | Penem Antibacterial beta Lactamase Inhibitor |
Mechanism of Action | beta Lactamase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for VABOMERE
US Patents and Regulatory Information for VABOMERE
VABOMERE is protected by seven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VABOMERE is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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 VABOMERE
Pharmaceutical compositions comprising cyclic boronic acid ester derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Therapeutic uses of pharmaceutical compositions comprising cyclic boronic acid ester derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, AND ENTEROBACTER CLOACAE SPECIES COMPLEX
Cyclic boronic acid ester derivatives and therapeutic uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTION (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, AND ENTEROBACTER CLOACAE SPECIES COMPLEX
Cyclic boronic acid ester derivatives and therapeutic uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, ENTEROBACTER CLOACAE SPECIES COMPLEX WITH MEROPENEM & VABORBACTAM AS SPECIFIED
Methods of treating bacterial infections
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI,KLEBSIELLA PNEUMONIA,ENTEROBACTER CLOACAE SPECIES COMPLEX WITH MEROPENEM & VABORBACTAM AS SPECIFIED
Cyclic boronic acid ester derivatives and therapeutic uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Cyclic boronic acid ester derivatives and therapeutic uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PATIENTS 18 YEARS OF AGE AND OLDER WITH COMPLICATED URINARY TRACT INFECTIONS CAUSED BY SUSCEPTIBLE MICROORGANISMS
FDA Regulatory Exclusivity protecting VABOMERE
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for VABOMERE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Menarini International Operations Luxembourg S.A. | Vaborem | meropenem, vaborbactam | EMEA/H/C/004669 Vaborem is indicated for the treatment of the following infections in adults:, , , Complicated urinary tract infection (cUTI), including pyelonephritis, Complicated intra-abdominal infection (cIAI), Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)., , , Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above., , Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options., , Consideration should be given to official guidance on the appropriate use of antibacterial agents., |
Authorised | no | no | no | 2018-11-20 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VABOMERE
When does loss-of-exclusivity occur for VABOMERE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 11289615
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2013003045
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 07546
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 13000399
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3180328
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 80667
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0200741
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 03514
Estimated Expiration: ⤷ Try a Trial
Patent: 12676
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 03514
Estimated Expiration: ⤷ Try a Trial
Patent: 12676
Estimated Expiration: ⤷ Try a Trial
Patent: 66778
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 40086
Estimated Expiration: ⤷ Try a Trial
Patent: 48859
Estimated Expiration: ⤷ Try a Trial
Patent: 900017
Estimated Expiration: ⤷ Try a Trial
Patent: 900018
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 4564
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 66978
Estimated Expiration: ⤷ Try a Trial
Patent: 02742
Estimated Expiration: ⤷ Try a Trial
Patent: 54861
Estimated Expiration: ⤷ Try a Trial
Patent: 27282
Estimated Expiration: ⤷ Try a Trial
Patent: 13535502
Estimated Expiration: ⤷ Try a Trial
Patent: 17052794
Estimated Expiration: ⤷ Try a Trial
Patent: 20002178
Estimated Expiration: ⤷ Try a Trial
Patent: 21073212
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 412676
Estimated Expiration: ⤷ Try a Trial
Patent: 412676D
Estimated Expiration: ⤷ Try a Trial
Patent: 2020519
Estimated Expiration: ⤷ Try a Trial
Patent: 2020521
Estimated Expiration: ⤷ Try a Trial
Patent: 12676
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 8960
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 8653
Estimated Expiration: ⤷ Try a Trial
Patent: 13001517
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 7354
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 19013
Estimated Expiration: ⤷ Try a Trial
Patent: 19014
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 03514
Estimated Expiration: ⤷ Try a Trial
Patent: 12676
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 03514
Estimated Expiration: ⤷ Try a Trial
Patent: 12676
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 99791
Estimated Expiration: ⤷ Try a Trial
Patent: 13104951
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 310
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 7757
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 12676
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1987091
Estimated Expiration: ⤷ Try a Trial
Patent: 2087313
Estimated Expiration: ⤷ Try a Trial
Patent: 2205755
Estimated Expiration: ⤷ Try a Trial
Patent: 130099923
Estimated Expiration: ⤷ Try a Trial
Patent: 190066084
Estimated Expiration: ⤷ Try a Trial
Patent: 200028043
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 91468
Estimated Expiration: ⤷ Try a Trial
Patent: 89177
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1815323
Estimated Expiration: ⤷ Try a Trial
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 VABOMERE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 2019014 | ⤷ Try a Trial | |
South Korea | 20130099923 | CYCLIC BORONIC ACID ESTER DERIVATIVES AND THERAPEUTIC USES THEREOF | ⤷ Try a Trial |
Hungary | S1900017 | ⤷ Try a Trial | |
Russian Federation | 2013104951 | ЦИКЛИЧЕСКИЕ БОРОНОВЫЕ КИСЛОТНО-ЭФИРНЫЕ ПРОИЗВОДНЫЕ И ИХ ИСПОЛЬЗОВАНИЕ В ТЕРАПИИ | ⤷ Try a Trial |
Poland | 3412676 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VABOMERE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2603514 | C02603514/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VABORBACTAM UND MEROPENEM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67797 01.07.2021 |
3412676 | PA2020521,C3412676 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VABORBAKTAMAS IR (ARBA) JO DRUSKA, IR (ARBA) JO HIDRATAS; REGISTRATION NO/DATE: EU/1/18/1334 20181120 |
2603514 | 122019000027 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON VABORBACTAM, ODER EIN SALZ ODER EIN HYDRAT DAVON, UND MEROPENEM, ODER EIN SALZ ODER EIN HYDRAT DAVON, INSBESONDERE MEROPENEMTRIHYDRAT; REGISTRATION NO/DATE: EU/1/18/1334 20181120 |
2603514 | 132019000000051 | Italy | ⤷ Try a Trial | PRODUCT NAME: COMBINAZIONE DI VABORBACTAM E/O UN SUO SALE E/O UN SUO IDRATO, E MEROPENEM, E/O UN SUO SALE E/O UN SUO IDRATO, IN PARTICOLARE MEROPENEM TRIIDRATO(VABOMERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1334, 20181122 |
2603514 | 2019013 | Norway | ⤷ Try a Trial | PRODUCT NAME: VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF; REG. NO/DATE: EU/1/18/1334 20181113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |