MEROPENEM; VABORBACTAM - Generic Drug Details
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What are the generic sources for meropenem; vaborbactam and what is the scope of freedom to operate?
Meropenem; vaborbactam
is the generic ingredient in one branded drug marketed by Rempex and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Meropenem; vaborbactam has seventy patent family members in thirty countries.
One supplier is listed for this compound.
Summary for MEROPENEM; VABORBACTAM
| International Patents: | 70 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 5 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MEROPENEM; VABORBACTAM |
| DailyMed Link: | MEROPENEM; VABORBACTAM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MEROPENEM; VABORBACTAM
Generic Entry Date for MEROPENEM; VABORBACTAM*:
Constraining patent/regulatory exclusivity:
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 MEROPENEM; VABORBACTAM
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 MEROPENEM; VABORBACTAM
| Drug Class | Penem Antibacterial beta Lactamase Inhibitor |
| Mechanism of Action | beta Lactamase Inhibitors |
US Patents and Regulatory Information for MEROPENEM; VABORBACTAM
| 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 | 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 MEROPENEM; VABORBACTAM
| 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 MEROPENEM; VABORBACTAM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 2019014 | ⤷ Try a Trial | |
| Chile | 2020000892 | Métodos para tratar infecciones bacterianas. | ⤷ Try a Trial |
| 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) | ⤷ Try a Trial |
| Hungary | S1900018 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MEROPENEM; VABORBACTAM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2603514 | C02603514/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VABORBACTAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67797 01.07.2021 |
| 2603514 | 19C1022 | France | ⤷ Try a Trial | PRODUCT NAME: VABORBACTAM, ET/OU UN SEL ET/OU UN HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/18/1334 20181122 |
| 2603514 | 2019C/514 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
| 2603514 | 1990017-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF VABORBACTAM AND/OR SALT OR HYDRATE THEREOF, AND MEROPENEM AND/OR A SALT HYDRATE THEREOF, IN PARTICULAR MEROPENEM TRIHYDRATE.; REG. NO/DATE: EU/1/18/1334 20181122 |
| >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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