AMPICILLIN SODIUM; SULBACTAM SODIUM - Generic Drug Details
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What are the generic drug sources for ampicillin sodium; sulbactam sodium and what is the scope of patent protection?
Ampicillin sodium; sulbactam sodium
is the generic ingredient in two branded drugs marketed by Acs Dobfar, Antibiotice, Astral, Eugia Pharma Speclts, Hikma, Hospira Inc, Hq Speclt Pharma, Istituto Bio Ita Spa, Pharm Assoc, Sandoz, Steriscience, and Pfizer, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.Twelve suppliers are listed for this compound.
Summary for AMPICILLIN SODIUM; SULBACTAM SODIUM
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 12 |
NDAs: | 25 |
Finished Product Suppliers / Packagers: | 12 |
Clinical Trials: | 2 |
DailyMed Link: | AMPICILLIN SODIUM; SULBACTAM SODIUM at DailyMed |
Recent Clinical Trials for AMPICILLIN SODIUM; SULBACTAM SODIUM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
DongGuk University | |
Pfizer | Phase 3 |
Pharmacology for AMPICILLIN SODIUM; SULBACTAM SODIUM
Drug Class | Penicillin-class Antibacterial beta Lactamase Inhibitor |
Mechanism of Action | beta Lactamase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for AMPICILLIN SODIUM; SULBACTAM SODIUM
US Patents and Regulatory Information for AMPICILLIN SODIUM; SULBACTAM SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eugia Pharma Speclts | AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090340-002 | Sep 20, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hospira Inc | AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090653-001 | Dec 21, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pfizer | UNASYN | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 050608-005 | Dec 10, 1993 | AP | RX | Yes | 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 |
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