Details for New Drug Application (NDA): 210910
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NDA 210910 describes AEMCOLO, which is a drug marketed by Redhill 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 AEMCOLO profile page.
The generic ingredient in AEMCOLO is rifamycin sodium. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rifamycin sodium profile page.
The generic ingredient in AEMCOLO is rifamycin sodium. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rifamycin sodium profile page.
Summary for 210910
| Tradename: | AEMCOLO |
| Applicant: | Redhill |
| Ingredient: | rifamycin sodium |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210910
Generic Entry Date for 210910*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
TABLET, DELAYED RELEASE;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.
Pharmacology for NDA: 210910
Suppliers and Packaging for NDA: 210910
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910 | NDA | RedHill Biopharma Ltd | 57841-1200 | 57841-1200-1 | 2 BLISTER PACK in 1 CARTON (57841-1200-1) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) |
| AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910 | NDA | RedHill Biopharma Ltd | 57841-1200 | 57841-1200-2 | 6 BLISTER PACK in 1 CARTON (57841-1200-2) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 194MG BASE | ||||
| Approval Date: | Nov 16, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Nov 16, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 8,263,120 | Patent Expiration: | May 3, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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