Details for New Drug Application (NDA): 213972
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NDA 213972 describes ORLYNVAH, which is a drug marketed by Iterum Therap and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ORLYNVAH profile page.
The generic ingredient in ORLYNVAH is probenecid; sulopenem etzadroxil. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the probenecid; sulopenem etzadroxil profile page.
The generic ingredient in ORLYNVAH is probenecid; sulopenem etzadroxil. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the probenecid; sulopenem etzadroxil profile page.
Summary for 213972
| Tradename: | ORLYNVAH |
| Applicant: | Iterum Therap |
| Ingredient: | probenecid; sulopenem etzadroxil |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213972
Generic Entry Date for 213972*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
TABLET;ORAL |
*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: 213972
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORLYNVAH | probenecid; sulopenem etzadroxil | TABLET;ORAL | 213972 | NDA | ITERUM THERAPEUTICS US LIMITED | 81153-100 | 81153-100-01 | 1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;500MG | ||||
| Approval Date: | Oct 25, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 25, 2034 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Oct 25, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,478,428 | Patent Expiration: | Dec 23, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE IN TREATING UNCOMPLICATED URINARY TRACT INFECTIONS CAUSED BY ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR PROTEUS MIRABILIS | ||||||||
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