aklief Drug Patent Profile
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Which patents cover Aklief, 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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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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aklief
*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 |
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.
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 | |||
| >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
Patent: Oil/water-emulsion-type topical compositions containing a retinoid
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2014029885
Patent: composições tópicas, que contêm um retinoide, de tipo emulsão óleo em água
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 74474
Patent: COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE, DE TYPE EMULSION HUILE DANS EAU (OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 14003226
Patent: Composiciones tópicas tipo emulsion aceite en agua, tal que la fase grasa comprende un retinoide, un solvente principal y un cosolvente, y la fase acuosa un agente gelificante; y su uso en el tratamiento de afecciones a la piel como acné común, rosácea, ictiosis, psoriasis, entre otras.
Estimated Expiration: ⤷ Sign Up
China
Patent: 4507469
Patent: Oil/water-emulsion-type topical compositions containing a retinoid
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 54802
Patent: COMPOSITIONS TOPIQUES, CONTENANT UN RÉTINOÏDE, DE TYPE ÉMULSION HUILE DANS EAU (TOPICAL OIL IN WATER EMULSION COMPOSITIONS COMPRISING A RETINOID)
Estimated Expiration: ⤷ Sign Up
France
Patent: 91177
Patent: COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE, DE TYPE EMULSION HUILE DANS EAU SANS EMULSIONNANT
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 04975
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 6001
Patent: תכשירים מסוג אמולסיית שמן/מים למתן מקומי הכוללים רטינואיד (Oil/water-emulsion-type topical compositions containing a retinoid)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 71527
Estimated Expiration: ⤷ Sign Up
Patent: 15523342
Patent: レチノイドを含有する油／水エマルション型局所的組成物
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 4540
Patent: COMPOSICIONES TOPICAS DE TIPO EMULSION ACEITE EN AGUA QUE CONTIENEN UN RETINOIDE. (OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID.)
Estimated Expiration: ⤷ Sign Up
Patent: 14014560
Patent: COMPOSICIONES TOPICAS DE TIPO EMULSION ACEITE EN AGUA QUE CONTIENEN UN RETINOIDE. (OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2472
Patent: Oil/water-emulsion-type topical compositions containing a retinoid
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 37408
Patent: СОДЕРЖАЩИЕ РЕТИНОИД КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ ТИПА ЭМУЛЬСИИ "МАСЛО В ВОДЕ" (RETINOID-CONTAINING COMPOUNDS FOR LOCAL APPLICATION OF "OIL IN WATER" EMULSION TYPE)
Estimated Expiration: ⤷ Sign Up
Patent: 14152998
Patent: СОДЕРЖАЩИЕ РЕТИНОИД КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ ТИПА ЭМУЛЬСИИ "МАСЛО В ВОДЕ"
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201408759X
Patent: OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1408744
Patent: OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2127022
Estimated Expiration: ⤷ Sign Up
Patent: 150028252
Patent: OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID
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 |
|---|---|---|---|
| France | 2991177 | COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE, DE TYPE EMULSION HUILE DANS EAU SANS EMULSIONNANT | ⤷ Sign Up |
| Canada | 2874474 | COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE, DE TYPE EMULSION HUILE DANS EAU (OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID) | ⤷ Sign Up |
| Brazil | 112014029879 | composições tópicas em forma de gel que contêm um retinoide particular solubilizado | ⤷ 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 | PA2022002,C1831149 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: UK, 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 | SPC/GB20/027 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TRIFAROTENE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK PL 10590/0071 -0001 20200113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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