Cilastatin sodium; imipenem; relebactam - Generic Drug Details
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What are the generic drug sources for cilastatin sodium; imipenem; relebactam and what is the scope of freedom to operate?
Cilastatin sodium; imipenem; relebactam
is the generic ingredient in one branded drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Cilastatin sodium; imipenem; relebactam has seventy-one patent family members in thirty-eight countries.
One supplier is listed for this compound.
Summary for cilastatin sodium; imipenem; relebactam
| International Patents: | 71 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| DailyMed Link: | cilastatin sodium; imipenem; relebactam at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cilastatin sodium; imipenem; relebactam
*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 cilastatin sodium; imipenem; relebactam
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 2 |
| Merck Sharp & Dohme Corp. | Phase 3 |
See all cilastatin sodium; imipenem; relebactam clinical trials
Pharmacology for cilastatin sodium; imipenem; relebactam
| Drug Class | Penem Antibacterial Renal Dehydropeptidase Inhibitor beta Lactamase Inhibitor |
| Mechanism of Action | Dipeptidase Inhibitors beta Lactamase Inhibitors |
US Patents and Regulatory Information for cilastatin sodium; imipenem; relebactam
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msd Merck Co | RECARBRIO | cilastatin sodium; imipenem; relebactam | POWDER;INTRAVENOUS | 212819-001 | Jul 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Merck Co | RECARBRIO | cilastatin sodium; imipenem; relebactam | POWDER;INTRAVENOUS | 212819-001 | Jul 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Merck Co | RECARBRIO | cilastatin sodium; imipenem; relebactam | POWDER;INTRAVENOUS | 212819-001 | Jul 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 cilastatin sodium; imipenem; relebactam
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 101648728 | ⤷ Sign Up | |
| Israel | 206395 | N-הטרוציקליל-7-אוקסו-6-סולפאוקסי-6,1-דיאזאביציקלו[1.2.3]אוקטן-2-קרבוקסאמידים ותכשירים רוקחיים המכילים אותם (N-heterocyclyl-7-oxo-6-sulfooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamides and pharmaceutical compositions comprising them) | ⤷ Sign Up |
| Serbia | 53052 | INHIBITORI BETA-LAKTAMAZE (BETA-LACTAMASE INHIBITORS) | ⤷ Sign Up |
| China | 101918407 | Beta-lactamase inhibitors | ⤷ Sign Up |
| Cyprus | 2020024 | ⤷ Sign Up | |
| Spain | 2433744 | ⤷ Sign Up | |
| Denmark | 2666774 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for cilastatin sodium; imipenem; relebactam
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2231667 | 20C1030 | France | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM OU UN MONOHYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1420 20200217 |
| 2666774 | CA 2020 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217 |
| 2231667 | 2020C/522 | Belgium | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE |
| 2231667 | CA 2020 00036 | Denmark | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM OR A MONOHYDRATE THEREOF; REG. NO/DATE: EU/1/19/1420 20200217 |
| 2666774 | PA2020517,C2666774-1 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, IR IMIPENEMAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213 |
| 2231667 | C202030033 | Spain | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM O SU MONOHIDRATO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1420; DATE OF AUTHORISATION: 20200213; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1420; DATE OF FIRST AUTHORISATION IN EEA: 20200213 |
| 2666774 | 301051 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE |
| >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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