Clofazimine - Generic Drug Details
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What are the generic drug sources for clofazimine and what is the scope of freedom to operate?
Clofazimine
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for clofazimine.
Summary for clofazimine
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 47 |
| Patent Applications: | 6,588 |
| DailyMed Link: | clofazimine at DailyMed |
Recent Clinical Trials for clofazimine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Medical Center for Infectious Diseases | Phase 3 |
| Beijing Chest Hospital | Phase 3 |
| Harvard School of Public Health (HSPH) | Phase 2 |
Medical Subject Heading (MeSH) Categories for clofazimine
Anatomical Therapeutic Chemical (ATC) Classes for clofazimine
US Patents and Regulatory Information for clofazimine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | LAMPRENE | clofazimine | CAPSULE;ORAL | 019500-001 | Dec 15, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | LAMPRENE | clofazimine | CAPSULE;ORAL | 019500-002 | Dec 15, 1986 | DISCN | Yes | 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 |
