Ampicillin/ampicillin trihydrate - Generic Drug Details
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What are the generic drug sources for ampicillin/ampicillin trihydrate and what is the scope of patent protection?
Ampicillin/ampicillin trihydrate
is the generic ingredient in fourteen branded drugs marketed by Parke Davis, Aurobindo Pharma, Belcher Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Lederle, Mylan, Purepac Pharm, Sandoz, Strides Pharma, Vitarine, Wyeth Ayerst, Pfizer, Bristol, Apothecon, Bristol Myers Squibb, Glaxosmithkline, Endo Operations, Teva, and Cosette, and is included in forty-four NDAs. Additional information is available in the individual branded drug profile pages.Three suppliers are listed for this compound.
Summary for ampicillin/ampicillin trihydrate
US Patents: | 0 |
Tradenames: | 14 |
Applicants: | 20 |
NDAs: | 44 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 67 |
Clinical Trials: | 1 |
Patent Applications: | 641 |
DailyMed Link: | ampicillin/ampicillin trihydrate at DailyMed |
Recent Clinical Trials for ampicillin/ampicillin trihydrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Federal University of São Paulo | Phase 4 |
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Pharmacology for ampicillin/ampicillin trihydrate
Drug Class | Penicillin-class Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for ampicillin/ampicillin trihydrate
US Patents and Regulatory Information for ampicillin/ampicillin trihydrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apothecon | PRINCIPEN | ampicillin/ampicillin trihydrate | FOR SUSPENSION;ORAL | 061394-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bristol Myers Squibb | PRINCIPEN | ampicillin/ampicillin trihydrate | CAPSULE;ORAL | 061392-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Wyeth Ayerst | OMNIPEN (AMPICILLIN) | ampicillin/ampicillin trihydrate | FOR SUSPENSION;ORAL | 060625-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mylan | AMPICILLIN TRIHYDRATE | ampicillin/ampicillin trihydrate | CAPSULE;ORAL | 061755-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apothecon | POLYCILLIN-PRB | ampicillin/ampicillin trihydrate; probenecid | FOR SUSPENSION;ORAL | 061898-001 | Approved Prior to Jan 1, 1982 | DISCN | 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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