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, Naska, Glaxosmithkline, and Saptalis Pharms, 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Naska | BACITRACIN ZINC-POLYMYXIN B SULFATE | bacitracin zinc; polymyxin b sulfate | OINTMENT;TOPICAL | 062849-001 | Nov 13, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Monarch Pharms | POLYSPORIN | bacitracin zinc; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 061229-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Combe | LANABIOTIC | bacitracin zinc; lidocaine; neomycin sulfate; polymyxin b sulfate | OINTMENT;TOPICAL | 062499-001 | Jun 3, 1985 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Monarch Pharms | CORTISPORIN | bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate | OINTMENT;TOPICAL | 050168-002 | May 4, 1984 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Casper Pharma Llc | CORTISPORIN | bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 050416-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bausch And Lomb | NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC | bacitracin zinc; neomycin sulfate; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 064064-001 | Oct 30, 1995 | AT | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Akorn | NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE | bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate | OINTMENT;OPHTHALMIC | 065213-001 | Jul 25, 2012 | DISCN | No | No | ⤷ 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 |
