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Last Updated: May 26, 2022

AKLIEF Drug Patent Profile


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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.

This drug has fifty-nine 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 will be eligible for patent challenges on October 4, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for AKLIEF
International Patents:59
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 24
Clinical Trials: 2
Patent Applications: 43
Drug Prices: Drug price information for AKLIEF
What excipients (inactive ingredients) are in AKLIEF?AKLIEF excipients list
DailyMed Link:AKLIEF at DailyMed
Drug patent expirations by year for AKLIEF
Drug Prices for AKLIEF

See drug prices for AKLIEF

DrugPatentWatch® Estimated Generic Entry Opportunity Date for AKLIEF
Generic Entry Date for AKLIEF*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Galderma R&DPhase 4

See all AKLIEF clinical trials

US Patents and Regulatory Information for AKLIEF

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AKLIEF is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Ligands that modulate RAR receptors and pharmaceutical/cosmetic compositions comprised thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ligands that modulate RAR receptors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS

Ligands that modulate RAR receptors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ACTIVATING RARGAMMA RECEPTOR

Topical compositions containing a retinoid of the oil-in-water emulsion type
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE VULGARIS

Topical compositions in the form of a gel containing a particular solubilized retinoid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS

FDA Regulatory Exclusivity protecting AKLIEF

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

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

Patent: 13269583
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014029885
Estimated Expiration: See Plans and Pricing

Canada

Patent: 74474
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14003226
Estimated Expiration: See Plans and Pricing

China

Patent: 4507469
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 54802
Estimated Expiration: See Plans and Pricing

France

Patent: 91177
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 04975
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6001
Estimated Expiration: See Plans and Pricing

Japan

Patent: 71527
Estimated Expiration: See Plans and Pricing

Patent: 15523342
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 4540
Estimated Expiration: See Plans and Pricing

Patent: 14014560
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2472
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 37408
Estimated Expiration: See Plans and Pricing

Patent: 14152998
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201408759X
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1408744
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2127022
Estimated Expiration: See Plans and Pricing

Patent: 150028252
Estimated Expiration: See Plans and Pricing

Spain

Patent: 91299
Estimated Expiration: See Plans and Pricing

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
Netherlands 301042 See Plans and Pricing
Japan 5258299 See Plans and Pricing
European Patent Office 2854803 COMPOSITIONS TOPIQUES SOUS FORME DE GEL CONTENANT UN RÉTINOÏDE PARTICULIER SOLUBILISÉ (TOPICAL GEL COMPOSITION COMPRISING A SOLUBILIZED SPECIFIC RETINOID) See Plans and Pricing
Australia 2013269582 Topical compositions in the form of a gel containing a particular solubilised retinoid See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AKLIEF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1831149 LUC00162 Luxembourg See Plans and Pricing PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: PL 105590/0071 - 0001 20200519
1831149 20C1025 France See Plans and Pricing 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 2020C/525 Belgium See Plans and Pricing PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224
1831149 PA2022002 Lithuania See Plans and Pricing PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: PL 10590/0071 20200113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
McKinsey
Harvard Business School
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Mallinckrodt

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.