Meropenem; vaborbactam - Generic Drug Details
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What are the generic drug sources for meropenem; vaborbactam and what is the scope of patent protection?
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 |
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 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 | 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 | ||||
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 | ⤷ 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 |
---|---|---|---|
Japan | 2020002178 | 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 DERIVATIVES AND THERAPEUTIC USES THEREOF) | ⤷ Try a Trial |
Hungary | S1900018 | ⤷ Try a Trial | |
New Zealand | 607354 | Cyclic boronic acid ester derivatives and therapeutic uses thereof | ⤷ Try a Trial |
Japan | 2013535502 | ⤷ Try a Trial | |
Spain | 2691468 | ⤷ Try a Trial | |
Canada | 3078238 | PROCEDES DE TRAITEMENT D'INFECTIONS BACTERIENNES (METHODS OF TREATING BACTERIAL INFECTIONS) | ⤷ 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 | 2019014 | Norway | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF VABORBACTAM, AND/OR A SALT AND/OR HYDRATE THEREOF, AND MEROPENEM, AND/OR A SALT AND/OR HYDRATE THEREOF, IN PARTICULAR MEROPENEM TRIHYDRATE; REG. NO/DATE: EU/1/18/1334/001 20181122 |
2603514 | C02603514/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VABORBACTAM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67797 01.07.2021 |
3412676 | PA2020519,C3412676 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VABORBAKTAMO IR (ARBA) JO DRUSKOS, IR (ARBA) HIDRATO BEI MEROPENEMO IR (ARBA) JO DRUSKOS, IR (ARBA) HIDRATO, YPAC MEROPENEMO TRIHIDRATO, DERINYS; REGISTRATION NO/DATE: EU/1/18/1334 20181120 |
3412676 | PA2020521 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VABORBAKTAMAS IR (ARBA) JO DRUSKA, IR (ARBA) JO HIDRATAS; REGISTRATION NO/DATE: EU/1/18/1334 20181120 |
3412676 | C20200017 00315 | Estonia | ⤷ Try a Trial | PRODUCT NAME: MEROPENEEM/VABORBAKTAAM;REG NO/DATE: EU/1/18/1334 22.11.2018 |
2603514 | 2019C/515 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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