Details for New Drug Application (NDA): 212819
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NDA 212819 describes RECARBRIO, which is a drug marketed by Msd Merck Co and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the RECARBRIO profile page.
The generic ingredient in RECARBRIO is cilastatin sodium; imipenem; relebactam. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cilastatin sodium; imipenem; relebactam profile page.
The generic ingredient in RECARBRIO is cilastatin sodium; imipenem; relebactam. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cilastatin sodium; imipenem; relebactam profile page.
Summary for 212819
| Tradename: | RECARBRIO |
| Applicant: | Msd Merck Co |
| Ingredient: | cilastatin sodium; imipenem; relebactam |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212819
Generic Entry Date for 212819*:
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.
Pharmacology for NDA: 212819
| Mechanism of Action | Dipeptidase Inhibitors beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 212819
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RECARBRIO | cilastatin sodium; imipenem; relebactam | POWDER;INTRAVENOUS | 212819 | NDA | Merck Sharp & Dohme LLC | 0006-3856 | 0006-3856-02 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | ||||
| Approval Date: | Jul 16, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 16, 2029 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Jul 16, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 8,487,093 | Patent Expiration: | Mar 21, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI) | ||||||||
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