Details for New Drug Application (NDA): 217347
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NDA 217347 describes SOFDRA, which is a drug marketed by Botanix Sb and is included in one NDA. It is available from one supplier. There are seventeen patents protecting this drug. Additional details are available on the SOFDRA profile page.
The generic ingredient in SOFDRA is sofpironium bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sofpironium bromide profile page.
The generic ingredient in SOFDRA is sofpironium bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sofpironium bromide profile page.
Summary for 217347
| Tradename: | SOFDRA |
| Applicant: | Botanix Sb |
| Ingredient: | sofpironium bromide |
| Patents: | 17 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217347
Generic Entry Date for 217347*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
GEL, METERED;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: 217347
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOFDRA | sofpironium bromide | GEL, METERED;TOPICAL | 217347 | NDA | Botanix SB Inc. | 83723-010 | 83723-010-50 | 1 BOTTLE in 1 CARTON (83723-010-50) / 50 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL, METERED;TOPICAL | Strength | EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) | ||||
| Approval Date: | Jun 18, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 20, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Mar 14, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 22, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER | ||||||||
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