Details for New Drug Application (NDA): 215153
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NDA 215153 describes VOQUEZNA DUAL PAK, which is a drug marketed by Phathom and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VOQUEZNA DUAL PAK profile page.
The generic ingredient in VOQUEZNA DUAL PAK is amoxicillin; 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; vonoprazan fumarate profile page.
The generic ingredient in VOQUEZNA DUAL PAK is amoxicillin; 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; vonoprazan fumarate profile page.
Summary for 215153
| Tradename: | VOQUEZNA DUAL PAK |
| Applicant: | Phathom |
| Ingredient: | amoxicillin; vonoprazan fumarate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215153
Generic Entry Date for 215153*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
CAPSULE, 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: 215153
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VOQUEZNA DUAL PAK | amoxicillin; vonoprazan fumarate | CAPSULE, TABLET;ORAL | 215153 | NDA | Phathom Pharmaceuticals Inc. | 81520-250 | 81520-250-14 | 14 BLISTER PACK in 1 CARTON (81520-250-14) / 1 KIT in 1 BLISTER PACK (81520-250-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, TABLET;ORAL | Strength | 500MG;EQ 20MG BASE | ||||
| Approval Date: | May 3, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 3, 2032 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | May 3, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 11, 2028 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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