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Last Updated: March 29, 2024

ACCUTANE Drug Patent Profile


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Which patents cover Accutane, and what generic alternatives are available?

Accutane is a drug marketed by Hoffmann La Roche and is included in one NDA.

The generic ingredient in ACCUTANE is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Accutane

A generic version of ACCUTANE was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.

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Drug patent expirations by year for ACCUTANE
Recent Clinical Trials for ACCUTANE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Vyne Therapeutics Inc.Phase 4
Edward Lain, MDPhase 4
Children's Oncology GroupPhase 2

See all ACCUTANE clinical trials

US Patents and Regulatory Information for ACCUTANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

Expired US Patents for ACCUTANE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-002 May 7, 1982 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-004 Mar 28, 1983 ⤷  Try a Trial ⤷  Try a Trial
Hoffmann La Roche ACCUTANE isotretinoin CAPSULE;ORAL 018662-003 May 7, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ACCUTANE

See the table below for patents covering ACCUTANE around the world.

Country Patent Number Title Estimated Expiration
Finland 63398 ⤷  Try a Trial
Austria 366683 ⤷  Try a Trial
Cyprus 1192 1-(1,3-DIOXOLAN-2-YL-METHYL)-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES ⤷  Try a Trial
Ireland 35391 PHARMACEUTICAL PREPARATIONS AND A PROCESS FOR THEIR MANUFACTURE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.