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Last Updated: November 2, 2024

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 six 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.
Summary for 214902
Tradename:TWYNEO
Applicant:Galderma Labs Lp
Ingredient:benzoyl peroxide; tretinoin
Patents:6
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:RXDosage:CREAM;TOPICALStrength3%;0.1%
Approval Date:Jul 26, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 26, 2024
Regulatory Exclusivity Use:NEW COMBINATION
Patent:⤷  Sign UpPatent Expiration:Jul 12, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER
Patent:⤷  Sign UpPatent Expiration:Dec 30, 2030Product Flag?YSubstance 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.