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Last Updated: November 2, 2024

ATRALIN Drug Patent Profile


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When do Atralin patents expire, and when can generic versions of Atralin launch?

Atralin is a drug marketed by Dow Pharm and is included in one NDA.

The generic ingredient in ATRALIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Atralin

A generic version of ATRALIN was approved as tretinoin by PADAGIS US on December 24th, 1998.

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Summary for ATRALIN
Drug patent expirations by year for ATRALIN
Drug Prices for ATRALIN

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Drug Sales Revenue Trends for ATRALIN

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Recent Clinical Trials for ATRALIN

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

SponsorPhase
Zeichner, Joshua, M.D.Phase 4
Johns Hopkins UniversityPhase 2
Bausch Health Americas, Inc.Phase 3

See all ATRALIN clinical trials

Pharmacology for ATRALIN
Drug ClassRetinoid

US Patents and Regulatory Information for ATRALIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dow Pharm ATRALIN tretinoin GEL;TOPICAL 022070-001 Jul 26, 2007 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  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 ATRALIN

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

Country Patent Number Title Estimated Expiration
African Intellectual Property Organization (OAPI) 9739 ⤷  Sign Up
Hungary 902444 ⤷  Sign Up
Israel 93928 ⤷  Sign Up
Norway 901657 ⤷  Sign Up
Australia 633892 ⤷  Sign Up
German Democratic Republic 298352 TRETINOIN ENTHALTENDE ZUBEREITUNG UND VERFAHREN ZU IHRER HERSTELLUNG ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ATRALIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 2013C/060 Belgium ⤷  Sign Up PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 132013902214376 Italy ⤷  Sign Up PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992 2013/044 Ireland ⤷  Sign Up PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
0617614 11/2001 Austria ⤷  Sign Up PRODUCT NAME: ALITRETINOIN; REGISTRATION NO/DATE: EU/1/00/149/001 20001011
1304992 122013000081 Germany ⤷  Sign Up PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992 PA2013025,C1304992 Lithuania ⤷  Sign Up PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
>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.