BACITRACIN ZINC - Generic Drug Details
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What are the generic sources for bacitracin zinc and what is the scope of patent protection?
Bacitracin zinc
is the generic ingredient in sixteen branded drugs marketed by X Gen Pharms, Padagis Us, Casper Pharma Llc, Akorn, Bausch And Lomb, Pharmafair, Monarch Pharms, Combe, Pharmaderm, Dow Pharm, Saptalis Pharms, Naska, and Glaxosmithkline, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for bacitracin zinc.
Summary for BACITRACIN ZINC
| US Patents: | 0 |
| Tradenames: | 16 |
| Applicants: | 13 |
| NDAs: | 24 |
| Drug Master File Entries: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 24 |
| Clinical Trials: | 31 |
| Patent Applications: | 54 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for BACITRACIN ZINC |
| DailyMed Link: | BACITRACIN ZINC at DailyMed |
Recent Clinical Trials for BACITRACIN ZINC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ohio State University | N/A |
| Cairo University | Early Phase 1 |
| University of Turin, Italy | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for BACITRACIN ZINC
US Patents and Regulatory Information for BACITRACIN ZINC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Padagis Us | BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE | bacitracin zinc; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 062166-002 | Approved Prior to Jan 1, 1982 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmaderm | BACITRACIN-NEOMYCIN-POLYMYXIN | bacitracin zinc; neomycin sulfate; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 062167-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | POLYSPORIN | bacitracin zinc; polymyxin b sulfate | AEROSOL;TOPICAL | 050167-002 | Mar 1, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Monarch Pharms | CORTISPORIN | bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate | OINTMENT;TOPICAL | 050168-002 | May 4, 1984 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bausch And Lomb | NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE | bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 064068-001 | Oct 30, 1995 | RX | No | Yes | ⤷ 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 |
