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Last Updated: September 25, 2021

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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-seven patent family members in twenty-six 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:57
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 17
Clinical Trials: 1
Patent Applications: 31
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

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>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

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2013178760 ⤷  Try it Free
Netherlands 301042 ⤷  Try it Free
Poland 1831149 ⤷  Try it Free
France 2991176 ⤷  Try it Free
World Intellectual Property Organization (WIPO) 2013178759 ⤷  Try it Free
Hong Kong 1204975 ⤷  Try it Free
Brazil 112014029885 ⤷  Try it Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for AKLIEF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1831149 C202030025 Spain ⤷  Try it Free PRODUCT NAME: TRIFAROTENO, OPCIONALMENT EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: 85017-SE/H/1863/001/DC; DATE OF AUTHORISATION: 20200417; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): PL 10590/0071 -0001; DATE OF FIRST AUTHORISATION IN EEA: 20200113
1831149 LUC00162 Luxembourg ⤷  Try it Free PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
1831149 2090021-3 Sweden ⤷  Try it Free PRODUCT NAME: TRIFAROTENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: MT NR:58467 20200131; FIRST REG.: GB PL 10590/0071 20200113
1831149 CA 2020 00027 Denmark ⤷  Try it Free PRODUCT NAME: TRIFAROTEN, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 61878 20200120; FIRST REG. NO/DATE: UK PL 10590/0071 20200113
1831149 C01831149/01 Switzerland ⤷  Try it Free PRODUCT NAME: TRIFAROTEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67632 17.12.2020
1831149 132020000000088 Italy ⤷  Try it Free PRODUCT NAME: TRIFAROTENE, FACOLTATIVAMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(SELGAMIS); AUTHORISATION NUMBER(S) AND DATE(S): PL 10590/0071 - 0001, 20200113;047209010-022-034-046, 20200520
1831149 2020C/525 Belgium ⤷  Try it Free PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Boehringer Ingelheim
McKinsey
Medtronic
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.