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Last Updated: March 29, 2024

Alitretinoin - Generic Drug Details


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What are the generic sources for alitretinoin and what is the scope of freedom to operate?

Alitretinoin is the generic ingredient in one branded drug marketed by Concordia and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for alitretinoin. One supplier is listed for this compound.

Summary for alitretinoin
Recent Clinical Trials for alitretinoin

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

SponsorPhase
LEO PharmaPhase 3
University Medical Center GroningenPhase 2
Sanofi GenzymePhase 2

See all alitretinoin clinical trials

Pharmacology for alitretinoin
Drug ClassRetinoid

US Patents and Regulatory Information for alitretinoin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Concordia PANRETIN alitretinoin GEL;TOPICAL 020886-001 Feb 2, 1999 RX Yes Yes ⤷  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

EU/EMA Drug Approvals for alitretinoin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Eisai GmbH Panretin alitretinoin EMEA/H/C/000279
Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome (AIDS)-related Kaposi's sarcoma (KS) when:lesions are not ulcerated or lymphoedematous, and;treatment of visceral KS is not required, and;lesions are not responding to systemic antiretroviral therapy, and;radiotherapy or chemotherapy are not appropriate.
Withdrawn no no no 2000-10-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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