Details for New Drug Application (NDA): 213004
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NDA 213004 describes TALICIA, which is a drug marketed by Redhill and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the TALICIA profile page.
The generic ingredient in TALICIA is amoxicillin; omeprazole magnesium; rifabutin. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; omeprazole magnesium; rifabutin profile page.
The generic ingredient in TALICIA is amoxicillin; omeprazole magnesium; rifabutin. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; omeprazole magnesium; rifabutin profile page.
Summary for 213004
| Tradename: | TALICIA |
| Applicant: | Redhill |
| Ingredient: | amoxicillin; omeprazole magnesium; rifabutin |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213004
Generic Entry Date for 213004*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
CAPSULE, 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: 213004
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 213004
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004 | NDA | RedHill Biopharma Ltd | 57841-1150 | 57841-1150-2 | 2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1) |
| TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004 | NDA | RedHill Biopharma Ltd | 57841-1150 | 57841-1150-4 | 2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 250MG;EQ 10MG BASE;12.5MG | ||||
| Approval Date: | Nov 1, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 1, 2027 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Nov 1, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,238,606 | Patent Expiration: | Feb 12, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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