DIRITHROMYCIN - Generic Drug Details
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What are the generic drug sources for dirithromycin and what is the scope of freedom to operate?
Dirithromycin
is the generic ingredient in one branded drug marketed by Lilly Res Labs 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 dirithromycin.
Summary for DIRITHROMYCIN
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 5 |
| Patent Applications: | 7,329 |
| DailyMed Link: | DIRITHROMYCIN at DailyMed |
Recent Clinical Trials for DIRITHROMYCIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pharmaceutical Research Unit, Jordan | Phase 1 |
| Abdi Ibrahim Ilac San. ve Tic A.S. | Phase 1 |
| Julio Ramirez | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for DIRITHROMYCIN
US Patents and Regulatory Information for DIRITHROMYCIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lilly Res Labs | DYNABAC | dirithromycin | TABLET, DELAYED RELEASE;ORAL | 050678-001 | Jun 19, 1995 | DISCN | 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 |
