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Last Updated: November 2, 2024

Acitretin - Generic Drug Details


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What are the generic drug sources for acitretin and what is the scope of patent protection?

Acitretin is the generic ingredient in two branded drugs marketed by Alembic, Barr Labs Inc, Impax Labs Inc, Mylan, Norvium Bioscience, Sigmapharm Labs Llc, Teva Pharms Usa, and Stiefel Labs Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for acitretin. Eight suppliers are listed for this compound.

Summary for acitretin
Drug Prices for acitretin

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Recent Clinical Trials for acitretin

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

SponsorPhase
Singapore General HospitalPhase 4
Translational Immunology InstitutePhase 4
South Valley UniversityPhase 4

See all acitretin clinical trials

Pharmacology for acitretin
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories for acitretin

US Patents and Regulatory Information for acitretin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sigmapharm Labs Llc ACITRETIN acitretin CAPSULE;ORAL 204633-001 May 22, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sigmapharm Labs Llc ACITRETIN acitretin CAPSULE;ORAL 204633-003 May 22, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Stiefel Labs Inc SORIATANE acitretin CAPSULE;ORAL 019821-002 Oct 28, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc ACITRETIN acitretin CAPSULE;ORAL 202552-004 Dec 23, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan ACITRETIN acitretin CAPSULE;ORAL 202148-002 Sep 10, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience ACITRETIN acitretin CAPSULE;ORAL 203707-002 Sep 10, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc ACITRETIN acitretin CAPSULE;ORAL 202552-003 Dec 23, 2015 AB RX No No ⤷  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

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