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Last Updated: November 4, 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

Supplementary Protection Certificates for ATRALIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 2013C/060 Belgium ⤷  Sign Up PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 CR 2013 00053 Denmark ⤷  Sign Up PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
0617614 SPC/GB01/014 United Kingdom ⤷  Sign Up PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
1304992 SPC/GB13/061 United Kingdom ⤷  Sign Up PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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