AKLIEF Drug Patent Profile
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Which patents cover Aklief, 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: | 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 |
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
Sponsor | Phase |
---|---|
Teva Pharmaceuticals USA | Phase 3 |
Teva Pharmaceuticals, Inc. | Phase 3 |
Galderma R&D | Phase 4 |
Pharmacology for AKLIEF
Drug Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for AKLIEF
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Ligands that modulate RAR receptors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS
Ligands that modulate RAR receptors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF ACTIVATING RARGAMMA RECEPTOR
Topical compositions containing a retinoid of the oil-in-water emulsion type
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACNE VULGARIS
Topical compositions in the form of a gel containing a particular solubilized retinoid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS
FDA Regulatory Exclusivity protecting AKLIEF
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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: ⤷ Sign Up
Brazil
Patent: 2014029885
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 74474
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 14003226
Estimated Expiration: ⤷ Sign Up
China
Patent: 4507469
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 54802
Estimated Expiration: ⤷ Sign Up
France
Patent: 91177
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 04975
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6001
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 71527
Estimated Expiration: ⤷ Sign Up
Patent: 15523342
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 4540
Estimated Expiration: ⤷ Sign Up
Patent: 14014560
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2472
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 37408
Estimated Expiration: ⤷ Sign Up
Patent: 14152998
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201408759X
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1408744
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2127022
Estimated Expiration: ⤷ Sign Up
Patent: 150028252
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 91299
Estimated Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | |
South Africa | 200705930 | Novel ligands that modulate rar receptors, and use thereof in human medicine and in cosmetics | ⤷ Sign Up |
Cyprus | 1112721 | ⤷ Sign Up | |
Japan | 2008525364 | ⤷ Sign Up | |
Russian Federation | 2014152998 | СОДЕРЖАЩИЕ РЕТИНОИД КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ ТИПА ЭМУЛЬСИИ "МАСЛО В ВОДЕ" | ⤷ Sign Up |
France | 2880020 | NOUVEAUX LIGANDS MODULATEURS DES RECEPTEURS RARs, UTILISATION EN MEDECINE HUMAINE AINSI QU'EN COSMETIQUE (New biphenyl amino compounds are retinoic acid nuclear receptors useful to treat e.g. acne, psoriasis and dermatitis) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AKLIEF
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1831149 | 20C1025 | France | ⤷ Sign Up | 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 | PA2022002 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: PL 10590/0071 20200113 |
1831149 | CR 2020 00027 | Denmark | ⤷ Sign Up | PRODUCT NAME: TRIFAROTEN, EVENTUELT I FORM AF ET SALT DERAF; NAT. REG. NO/DATE: 61878 20200120; FIRST REG. NO/DATE: UK PL 10590/0071 20200113 |
1831149 | LUC00162 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: PL 105590/0071 - 0001 20200519 |
1831149 | PA2022002,C1831149 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: UK, PL 10590/0071 20200113 |
1831149 | 2020/023 | Ireland | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |