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
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 8 |
NDAs: | 8 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 119 |
Clinical Trials: | 37 |
Patent Applications: | 6,746 |
Drug Prices: | Drug price trends for acitretin |
What excipients (inactive ingredients) are in acitretin? | acitretin excipients list |
DailyMed Link: | acitretin at DailyMed |
Recent Clinical Trials for acitretin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Singapore General Hospital | Phase 4 |
Translational Immunology Institute | Phase 4 |
South Valley University | Phase 4 |
Pharmacology for acitretin
Drug Class | Retinoid |
Medical Subject Heading (MeSH) Categories for acitretin
Anatomical Therapeutic Chemical (ATC) Classes 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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