Ampicillin sodium; sulbactam sodium - Generic Drug Details
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What are the generic 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, Eurofarma, Hikma, Hospira Inc, Hq Speclt Pharma, Istituto Bio Ita Spa, Onesource Specialty, Sandoz, and Pfizer, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.Thirteen 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: | 13 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 4 |
| Patent Applications: | 982 |
| 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 |
|---|---|
| The George Institute | PHASE3 |
| Ain Shams University | PHASE2 |
| DongGuk University |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065310-001 | Jul 25, 2006 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Eugia Pharma Speclts | AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 090339-001 | Sep 20, 2010 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Pfizer | UNASYN | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 050608-005 | Dec 10, 1993 | AP | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Istituto Bio Ita Spa | AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065314-001 | Nov 27, 2006 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sandoz | AMPICILLIN AND SULBACTAM | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 065310-002 | Jul 25, 2006 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Pfizer | UNASYN | ampicillin sodium; sulbactam sodium | INJECTABLE;INJECTION | 062901-002 | Feb 27, 1992 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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