Details for New Drug Application (NDA): 211527

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NDA 211527 describes AKLIEF, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the AKLIEF profile page.

The generic ingredient in AKLIEF is trifarotene. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trifarotene profile page.

Summary for 211527

Tradename:	AKLIEF
Applicant:	Galderma Labs Lp
Ingredient:	trifarotene
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211527

Generic Entry Date for 211527^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: ⤷ Get Started Free 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: 211527

Suppliers and Packaging for NDA: 211527

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AKLIEF	trifarotene	CREAM;TOPICAL	211527	NDA	Galderma Laboratories, L.P.	0299-5935	0299-5935-02	1 TUBE in 1 BLISTER PACK (0299-5935-02) / 2 g in 1 TUBE
AKLIEF	trifarotene	CREAM;TOPICAL	211527	NDA	Galderma Laboratories, L.P.	0299-5935	0299-5935-45	1 BOTTLE, PUMP in 1 CARTON (0299-5935-45) / 45 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.005%
Approval Date:	Oct 4, 2019	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Jul 19, 2031	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	May 30, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACNE VULGARIS
Patent:	⤷ Get Started Free	Patent Expiration:	May 30, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS

Expired US Patents for NDA 211527

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019	⤷ Get Started Free	⤷ Get Started Free
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.