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AKLIEF Drug Patent Profile

When do Aklief patents expire, and when can generic versions of Aklief launch?

Aklief is a drug marketed by Galderma Labs Lp and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has sixty patent family members in twenty-eight countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Aklief

Aklief was eligible for patent challenges on October 4, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 30, 2033. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for AKLIEF

International Patents:	60
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	4
Patent Applications:	28
Drug Prices:	Drug price information for AKLIEF
What excipients (inactive ingredients) are in AKLIEF?	AKLIEF excipients list
DailyMed Link:	AKLIEF at DailyMed

See drug prices for AKLIEF

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

NDA:

211527

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.

Recent Clinical Trials for AKLIEF

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Taro Pharmaceuticals USA	Phase 1
Teva Pharmaceuticals USA	Phase 3
Teva Pharmaceuticals, Inc.	Phase 3

See all AKLIEF clinical trials

Pharmacology for AKLIEF

Drug Class

Retinoid

Paragraph IV (Patent) Challenges for AKLIEF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AKLIEF	Cream	trifarotene	0.005%	211527	2	2023-10-04

US Patents and Regulatory Information for AKLIEF

AKLIEF is protected by five US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting AKLIEF

FDA Regulatory Exclusivity protecting AKLIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes			Y
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes			Y
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes			Y	Y

International Patents for AKLIEF

When does loss-of-exclusivity occur for AKLIEF?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

European Patent Office

France

Hong Kong

Israel

Japan

Mexico

New Zealand

Russian Federation

Singapore

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AKLIEF around the world.

Country	Patent Number	Title	Estimated Expiration
France	2991177	COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE, DE TYPE EMULSION HUILE DANS EAU SANS EMULSIONNANT
Canada	2874474	COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE, DE TYPE EMULSION HUILE DANS EAU (OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID)
Brazil	112014029879	composições tópicas em forma de gel que contêm um retinoide particular solubilizado
Mexico	2014014517	COMPOSICIONES TOPICAS BAJO LA FORMA DE UN GEL QUE CONTIENE UN RETINOIDE PARTICULAR SOLUBILIZADO. (TOPICAL COMPOSITIONS IN THE FORM OF A GEL CONTAINING A PARTICULAR SOLUBILISED RETINOID.)
Slovenia	1831149
Denmark	1831149
South Korea	20150028251	TOPICAL COMPOSITIONS IN THE FORM OF A GEL CONTAINING A PARTICULAR SOLUBILISED RETINOID

Supplementary Protection Certificates for AKLIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1831149	PA2022002,C1831149	Lithuania		PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: UK, PL 10590/0071 20200113
1831149	PA2022002	Lithuania		PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: PL 10590/0071 20200113
1831149	SPC/GB20/027	United Kingdom		PRODUCT NAME: TRIFAROTENE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK PL 10590/0071 -0001 20200113
1831149	C 2022 002	Romania		PRODUCT NAME: TRIFAROTEN, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE DIN PUNCT DE VEDERE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: 14177/2021//01-02-03-04; DATE OF NATIONAL AUTHORISATION: 20211124; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UK. PL 10590/0071; DATE OF FIRST AUTHORISATION IN EEA: 20200113
1831149	301042	Netherlands		PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATIONAL REGISTRATION NO/DATE: RVG 124058 20200310; FIRST REGISTRATION: GB PL 10590/0071 20200113
1831149	20C1025	France		PRODUCT NAME: TRIFAROTENE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: CIS 6 363 190 8 20200217; FIRST REGISTRATION: GB - PL 10590/0071 20200113
1831149	2090021-3	Sweden		PRODUCT NAME: TRIFAROTENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: MT NR:58467 20200131; FIRST REG.: GB PL 10590/0071 20200113