AMPICILLIN SODIUM Drug Patent Profile
When do Ampicillin Sodium patents expire, and when can generic versions of Ampicillin Sodium launch?
Ampicillin Sodium is a drug marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Consolidated Pharm, Eugia Pharma Speclts, Hikma, Hospira, Hq Speclt Pharma, Intl Medication, Lilly, Onesource Specialty, Sagent Pharms Inc, Sandoz, and Watson Labs Inc. and is included in twenty-five NDAs.
The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ampicillin Sodium
A generic version of AMPICILLIN SODIUM was approved as ampicillin sodium by SANDOZ on December 31st, 1969.
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Summary for AMPICILLIN SODIUM
| US Patents: | 0 |
| Applicants: | 14 |
| NDAs: | 25 |
| Finished Product Suppliers / Packagers: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 13 |
| Patent Applications: | 2,012 |
| DailyMed Link: | AMPICILLIN SODIUM at DailyMed |
Recent Clinical Trials for AMPICILLIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The George Institute | PHASE3 |
| Ain Shams University | PHASE2 |
| M.D. Anderson Cancer Center | Phase 2 |
Pharmacology for AMPICILLIN SODIUM
| Drug Class | Penicillin-class Antibacterial |
Medical Subject Heading (MeSH) Categories for AMPICILLIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for AMPICILLIN SODIUM
US Patents and Regulatory Information for AMPICILLIN 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 SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 061395-003 | Approved Prior to Jan 1, 1982 | AP | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hospira | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 202864-002 | Sep 4, 2015 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hikma | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062692-005 | Jun 24, 1986 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hq Speclt Pharma | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062772-007 | Apr 15, 1993 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Onesource Specialty | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 201025-002 | Apr 9, 2014 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hq Speclt Pharma | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062772-004 | Apr 15, 1993 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hq Speclt Pharma | AMPICILLIN SODIUM | ampicillin sodium | INJECTABLE;INJECTION | 062772-008 | Apr 15, 1993 | 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 |
