Details for New Drug Application (NDA): 214902
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NDA 214902 describes TWYNEO, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the TWYNEO profile page.
The generic ingredient in TWYNEO is benzoyl peroxide; tretinoin. 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; tretinoin profile page.
The generic ingredient in TWYNEO is benzoyl peroxide; tretinoin. 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; tretinoin profile page.
Summary for 214902
| Tradename: | TWYNEO |
| Applicant: | Galderma Labs Lp |
| Ingredient: | benzoyl peroxide; tretinoin |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214902
Generic Entry Date for 214902*:
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.
Pharmacology for NDA: 214902
Suppliers and Packaging for NDA: 214902
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902 | NDA | Galderma Laboratories, L.P. | 0299-5945 | 0299-5945-00 | 6 g in 1 TUBE (0299-5945-00) |
| TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902 | NDA | Galderma Laboratories, L.P. | 0299-5945 | 0299-5945-05 | 30 g in 1 BOTTLE, PUMP (0299-5945-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 3%;0.1% | ||||
| Approval Date: | Jul 26, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 26, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW COMBINATION | ||||||||
| Patent: | 10,420,743 | Patent Expiration: | Jul 12, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 10,653,899 | Patent Expiration: | Dec 30, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER | ||||||||
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