Details for New Drug Application (NDA): 215151
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NDA 215151 describes VOQUEZNA, which is a drug marketed by Phathom and is included in three NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VOQUEZNA profile page.
The generic ingredient in VOQUEZNA is amoxicillin; clarithromycin; vonoprazan fumarate. 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; clarithromycin; vonoprazan fumarate profile page.
The generic ingredient in VOQUEZNA is amoxicillin; clarithromycin; vonoprazan fumarate. 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; clarithromycin; vonoprazan fumarate profile page.
Summary for 215151
| Tradename: | VOQUEZNA |
| Applicant: | Phathom |
| Ingredient: | vonoprazan fumarate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215151
Generic Entry Date for 215151*:
Constraining patent/regulatory exclusivity:
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: 215151
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151 | NDA | Phathom Pharmaceuticals Inc. | 81520-100 | 81520-100-30 | 30 TABLET in 1 BOTTLE, PLASTIC (81520-100-30) |
| VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151 | NDA | Phathom Pharmaceuticals Inc. | 81520-200 | 81520-200-30 | 30 TABLET in 1 BOTTLE, PLASTIC (81520-200-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Nov 1, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 3, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Nov 1, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Jul 17, 2027 | ||||||||
| Regulatory Exclusivity Use: | USE OF VONOPRAZAN FOR THE RELIEF OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE IN ADULTS | ||||||||
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