VABOMERE Drug Patent Profile
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Which patents cover Vabomere, and when can generic versions of Vabomere launch?
Vabomere is a drug marketed by Rempex and is included in one NDA. There are seven patents protecting this drug.
This drug has seventy-four patent family members in thirty-one 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: | 74 |
| 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
*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 |
| Department of Health and Human Services | Phase 1 |
| Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) | 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 ⤷ 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 VABOMERE
Pharmaceutical compositions comprising cyclic boronic acid ester derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Therapeutic uses of pharmaceutical compositions comprising cyclic boronic acid ester derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Cyclic boronic acid ester derivatives and therapeutic uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 pyelonephritisComplicated 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: ⤷ Sign Up
Brazil
Patent: 2013003045
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 07546
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 13000399
Estimated Expiration: ⤷ Sign Up
China
Patent: 3180328
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 80667
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0200741
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 23208
Estimated Expiration: ⤷ Sign Up
Patent: 20019
Estimated Expiration: ⤷ Sign Up
Patent: 20020
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 03514
Estimated Expiration: ⤷ Sign Up
Patent: 12676
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 03514
Estimated Expiration: ⤷ Sign Up
Patent: 12676
Estimated Expiration: ⤷ Sign Up
Patent: 66778
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 40086
Estimated Expiration: ⤷ Sign Up
Patent: 48859
Estimated Expiration: ⤷ Sign Up
Patent: 900017
Estimated Expiration: ⤷ Sign Up
Patent: 900018
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4564
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 66978
Estimated Expiration: ⤷ Sign Up
Patent: 02742
Estimated Expiration: ⤷ Sign Up
Patent: 54861
Estimated Expiration: ⤷ Sign Up
Patent: 27282
Estimated Expiration: ⤷ Sign Up
Patent: 13535502
Estimated Expiration: ⤷ Sign Up
Patent: 17052794
Estimated Expiration: ⤷ Sign Up
Patent: 20002178
Estimated Expiration: ⤷ Sign Up
Patent: 21073212
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 412676
Estimated Expiration: ⤷ Sign Up
Patent: 412676D
Estimated Expiration: ⤷ Sign Up
Patent: 2020519
Estimated Expiration: ⤷ Sign Up
Patent: 2020521
Estimated Expiration: ⤷ Sign Up
Patent: 12676
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 8960
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 8653
Estimated Expiration: ⤷ Sign Up
Patent: 13001517
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 7354
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 19013
Estimated Expiration: ⤷ Sign Up
Patent: 19014
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 03514
Estimated Expiration: ⤷ Sign Up
Patent: 12676
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 03514
Estimated Expiration: ⤷ Sign Up
Patent: 12676
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 99791
Estimated Expiration: ⤷ Sign Up
Patent: 13104951
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 310
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 7757
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 12676
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1987091
Estimated Expiration: ⤷ Sign Up
Patent: 2087313
Estimated Expiration: ⤷ Sign Up
Patent: 2205755
Estimated Expiration: ⤷ Sign Up
Patent: 130099923
Estimated Expiration: ⤷ Sign Up
Patent: 190066084
Estimated Expiration: ⤷ Sign Up
Patent: 200028043
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 91468
Estimated Expiration: ⤷ Sign Up
Patent: 89177
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1815323
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 VABOMERE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2691468 | ⤷ Sign Up | |
| Poland | 3412676 | ⤷ Sign Up | |
| Norway | 2019013 | ⤷ Sign Up | |
| Japan | 2021073212 | 環状ボロン酸エステル誘導体およびその治療的使用 (CYCLIC BORONIC ACID ESTER DERIVATIVE AND METHOD OF MAKING THE SAME) | ⤷ Sign Up |
| >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 | ⤷ Sign Up | PRODUCT NAME: VABORBACTAM UND MEROPENEM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67797 01.07.2021 |
| 2603514 | 2019C/514 | Belgium | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
| 2603514 | SPC/GB19/020 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF.; REGISTERED: UK EU/1/18/1334 (NI) 20181120; UK PLGB 16239/0061 20181120 |
| 2603514 | 122019000027 | Germany | ⤷ Sign Up | 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 |
| >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.
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