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Last Updated: March 28, 2024

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aklief Drug Patent Profile


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When do Aklief patents expire, and what generic alternatives are available?

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

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  Try a Trial

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: 3
Patent Applications: 30
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 Loss of Exclusivity (LOE) 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
Teva Pharmaceuticals USAPhase 3
Teva Pharmaceuticals, Inc.Phase 3
Galderma R&DPhase 4

See all aklief clinical trials

Pharmacology for aklief
Drug ClassRetinoid
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of aklief is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Ligands that modulate RAR receptors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS

Ligands that modulate RAR receptors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF ACTIVATING RARGAMMA RECEPTOR

Topical compositions containing a retinoid of the oil-in-water emulsion type
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ACNE VULGARIS

Topical compositions in the form of a gel containing a particular solubilized retinoid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS

FDA Regulatory Exclusivity protecting aklief

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

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

Brazil

Patent: 2014029885
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 74474
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 14003226
Estimated Expiration: ⤷  Try a Trial

China

Patent: 4507469
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 54802
Estimated Expiration: ⤷  Try a Trial

France

Patent: 91177
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 04975
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6001
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 71527
Estimated Expiration: ⤷  Try a Trial

Patent: 15523342
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 4540
Estimated Expiration: ⤷  Try a Trial

Patent: 14014560
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 2472
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 37408
Estimated Expiration: ⤷  Try a Trial

Patent: 14152998
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201408759X
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1408744
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2127022
Estimated Expiration: ⤷  Try a Trial

Patent: 150028252
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 91299
Estimated Expiration: ⤷  Try a Trial

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
Portugal 1831149 ⤷  Try a Trial
Mexico 2007007696 COMPUESTOS LIGANDOS MODULADORES DE LOS RECEPTORES NUCLEARES DEL ACIDO RETINOICO(RARS) Y USO EN MEDICINA HUMANA Y EN COSMETICOS. (NOVEL LIGANDS THAT MODULATE RAR RECEPTORS, AND USE THEREOF IN HUMAN MEDICINE AND IN COSMETICS.) ⤷  Try a Trial
China 104507469 Oil/water-emulsion-type topical compositions containing a retinoid ⤷  Try a Trial
Japan 2008525364 ⤷  Try a Trial
Mexico 354540 COMPOSICIONES TOPICAS DE TIPO EMULSION ACEITE EN AGUA QUE CONTIENEN UN RETINOIDE. (OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID.) ⤷  Try a Trial
South Korea 20070087626 NOVEL LIGANDS THAT MODULATE RAR RECEPTORS, AND USE THEREOF IN HUMAN MEDICINE AND IN COSMETICS ⤷  Try a Trial
Hong Kong 1204975 含有類維生素 的水包油乳液型局部組合物 (OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING RETINOID) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aklief

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1831149 132020000000088 Italy ⤷  Try a Trial 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 122020000029 Germany ⤷  Try a Trial PRODUCT NAME: TRIFAROTEN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE VON TRIFAROTEN; NAT. REGISTRATION NO/DATE: 2203224.00.00 20200415; FIRST REGISTRATION: GB PL 10590/0071 - 0001 20200113
1831149 CA 2020 00027 Denmark ⤷  Try a Trial 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 2020C/525 Belgium ⤷  Try a Trial PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224
1831149 2020/023 Ireland ⤷  Try a Trial PRODUCT NAME: TRIFAROTENE, OPTIONALLY IN THE FORM OF APHARMACEUTICALLY ACCEPTABLE SALT; NAT REGISTRATION NO/DATE: PA0590/031/001 20200221; FIRST REGISTRATION NO/DATE: PL 10590/0071-0001 13/01/2020
1831149 2090021-3 Sweden ⤷  Try a Trial 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 LUC00162 Luxembourg ⤷  Try a Trial PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: PL 105590/0071 - 0001 20200519
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.