Details for New Drug Application (NDA): 217424
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NDA 217424 describes ZELSUVMI, which is a drug marketed by Lnhc and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the ZELSUVMI profile page.
The generic ingredient in ZELSUVMI is berdazimer sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the berdazimer sodium profile page.
The generic ingredient in ZELSUVMI is berdazimer sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the berdazimer sodium profile page.
Summary for 217424
| Tradename: | ZELSUVMI |
| Applicant: | Lnhc |
| Ingredient: | berdazimer sodium |
| Patents: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217424
Generic Entry Date for 217424*:
Constraining patent/regulatory exclusivity:
Dosage:
GEL;TOPICAL |
*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: 217424
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZELSUVMI | berdazimer sodium | GEL;TOPICAL | 217424 | NDA | LNHC, Inc. | 83787-103 | 83787-103-31 | 1 KIT in 1 KIT (83787-103-31) * 1 TUBE in 1 CARTON / 17 g in 1 TUBE * 1 TUBE in 1 CARTON / 14 g in 1 TUBE (83787-113-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | EQ 10.3% BASE | ||||
| Approval Date: | Jan 5, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 5, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 22, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TOPICALLY REDUCING LESIONS WITH TWO SEPARATELY STORED COMPONENTS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 22, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TOPICALLY REDUCING LESIONS WITH TWO SEPARATELY STORED COMPONENTS WHERE ONE COMPONENT INCLUDES A NITRIC OXIDE RELEASING COMPOUND | ||||||||
Expired US Patents for NDA 217424
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lnhc | ZELSUVMI | berdazimer sodium | GEL;TOPICAL | 217424-001 | Jan 5, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| Lnhc | ZELSUVMI | berdazimer sodium | GEL;TOPICAL | 217424-001 | Jan 5, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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