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
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 20 |
Patent Applications: | 7,596 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in alitretinoin? | alitretinoin excipients list |
DailyMed Link: | alitretinoin at DailyMed |
Recent Clinical Trials for alitretinoin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
LEO Pharma | Phase 3 |
University Medical Center Groningen | Phase 2 |
Sanofi Genzyme | Phase 2 |
Pharmacology for alitretinoin
Drug Class | Retinoid |
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 |
Expired US Patents for alitretinoin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Concordia | PANRETIN | alitretinoin | GEL;TOPICAL | 020886-001 | Feb 2, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Concordia | PANRETIN | alitretinoin | GEL;TOPICAL | 020886-001 | Feb 2, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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