Details for New Drug Application (NDA): 212271
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NDA 212271 describes CONTEPO, which is a drug marketed by Meitheal and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the CONTEPO profile page.
The generic ingredient in CONTEPO is fosfomycin disodium. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fosfomycin disodium profile page.
The generic ingredient in CONTEPO is fosfomycin disodium. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fosfomycin disodium profile page.
Summary for 212271
| Tradename: | CONTEPO |
| Applicant: | Meitheal |
| Ingredient: | fosfomycin disodium |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212271
Generic Entry Date for 212271*:
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.
Suppliers and Packaging for NDA: 212271
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CONTEPO | fosfomycin disodium | POWDER;INTRAVENOUS | 212271 | NDA | Meitheal Pharmaceuticals Inc. | 71288-035 | 71288-035-52 | 12 VIAL, GLASS in 1 CARTON (71288-035-52) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (71288-035-51) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 6GM BASE/VIAL | ||||
| Approval Date: | Oct 22, 2025 | TE: | RLD: | Yes | |||||
| Patent: | 10,086,006 | Patent Expiration: | Oct 12, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH COMPLICATED URINARY TRACT INFECTIONS INCLUDING ACUTE PYELONEPHRITIS CAUSED BY SUSCEPTIBLE ISOLATES OF ESCHERICHIA COLI AND KLEBSIELLA PNEUMONIAE | ||||||||
| Patent: | 11,541,064 | Patent Expiration: | Jan 30, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF RENALLY IMPAIRED PATIENTS WITH COMPLICATED URINARY TRACT INFECTIONS INCLUDING ACUTE PYELONEPHRITIS CAUSED BY SUSCEPTIBLE ISOLATES OF ESCHERICHIA COLI AND KLEBSIELLA PNEUMONIAE | ||||||||
| Patent: | 9,345,717 | Patent Expiration: | Oct 27, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH COMPLICATED URINARY TRACT INFECTIONS INCLUDING ACUTE PYELONEPHRITIS CAUSED BY SUSCEPTIBLE ISOLATES OF ESCHERICHIA COLI AND KLEBSIELLA PNEUMONIAE | ||||||||
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