Details for New Drug Application (NDA): 214510
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NDA 214510 describes EPSOLAY, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the EPSOLAY profile page.
The generic ingredient in EPSOLAY is benzoyl peroxide. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benzoyl peroxide profile page.
The generic ingredient in EPSOLAY is benzoyl peroxide. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benzoyl peroxide profile page.
Summary for 214510
| Tradename: | EPSOLAY |
| Applicant: | Galderma Labs Lp |
| Ingredient: | benzoyl peroxide |
| Patents: | 9 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214510
Generic Entry Date for 214510*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;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: 214510
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510 | NDA | Galderma Laboratories, L.P. | 0299-5890 | 0299-5890-00 | 3 g in 1 BOTTLE, PUMP (0299-5890-00) |
| EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510 | NDA | Galderma Laboratories, L.P. | 0299-5890 | 0299-5890-30 | 1 BOTTLE, PUMP in 1 BOX (0299-5890-30) / 30 g in 1 BOTTLE, PUMP |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 5% | ||||
| Approval Date: | Apr 22, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 19, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 19, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 18 YEARS OF AGE AND OLDER | ||||||||
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