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Last Updated: July 6, 2020

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AKLIEF Drug 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 four patents protecting this drug.

This drug has forty-four patent family members in twenty-five 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.

US ANDA Litigation and 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:44
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 9
Patent Applications: 18
Drug Prices: Drug price information for AKLIEF
DailyMed Link:AKLIEF at DailyMed
Drug patent expirations by year for AKLIEF
Drug Prices for AKLIEF

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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.

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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
McKinsey
Harvard Business School
Colorcon
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.