TOBRAMYCIN SULFATE - Generic Drug Details
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What are the generic drug sources for tobramycin sulfate and what is the scope of freedom to operate?
Tobramycin sulfate
is the generic ingredient in four branded drugs marketed by Lilly, Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Teva Pharms Usa, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for tobramycin sulfate. Eleven suppliers are listed for this compound.
Summary for TOBRAMYCIN SULFATE
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 16 |
NDAs: | 36 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 105 |
Clinical Trials: | 5 |
Patent Applications: | 6,749 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in TOBRAMYCIN SULFATE? | TOBRAMYCIN SULFATE excipients list |
DailyMed Link: | TOBRAMYCIN SULFATE at DailyMed |
Recent Clinical Trials for TOBRAMYCIN SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Madonna Magdy Fahmy | Early Phase 1 |
Joint Purification Systems | Phase 2 |
Osteal Therapeutics, Inc. | Phase 2 |
Pharmacology for TOBRAMYCIN SULFATE
Drug Class | Aminoglycoside Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for TOBRAMYCIN SULFATE
US Patents and Regulatory Information for TOBRAMYCIN SULFATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms Usa | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063100-001 | Jan 30, 1992 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063118-001 | Jul 29, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hospira | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 063161-001 | May 29, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hospira | TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | tobramycin sulfate | INJECTABLE;INJECTION | 063081-006 | Jun 2, 1993 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Watson Labs Inc | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 062945-002 | Aug 9, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gland Pharma Ltd | TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 211189-001 | May 18, 2021 | AP | 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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