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CEFTRIAXONE Drug Profile
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» See Plans and PricingWhich patents cover Ceftriaxone, and when can generic versions of Ceftriaxone launch?
Ceftriaxone is a drug marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, Akorn Inc, Astral, Cephazone Pharma, Hikma Farmaceutica, Teva Pharms Usa, B Braun, Baxter Hlthcare, and Hikma. and is included in thirty-six NDAs.
The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Ceftriaxone
A generic version of CEFTRIAXONE was approved as ceftriaxone sodium by ASTRAL on January 20th, 2017.
Summary for CEFTRIAXONE
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 36 |
| Suppliers / Packagers: | 20 |
| Bulk Api Vendors: | 35 |
| Clinical Trials: | 138 |
| Patent Applications: | 6,261 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CEFTRIAXONE |
| DailyMed Link: | CEFTRIAXONE at DailyMed |
Recent Clinical Trials for CEFTRIAXONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Merck Sharp & Dohme (Australia) Pty Limited | Phase 3 |
| The University of Queensland | Phase 3 |
| Centre Hospitalier Universitaire de la Réunion | Phase 4 |
Pharmacology for CEFTRIAXONE
| Drug Class | Cephalosporin Antibacterial |
US Patents and Regulatory Information for CEFTRIAXONE
| 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 | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065227-004 | Mar 15, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Cephazone Pharma | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065294-001 | Mar 26, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Aurobindo Pharma Ltd | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065505-004 | Jul 31, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Hikma Farmaceutica | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065342-003 | Jan 10, 2008 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lupin | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065125-002 | Sep 30, 2003 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Fresenius Kabi Usa | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065245-003 | Feb 15, 2006 | 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 |
