AZTREONAM Drug Patent Profile
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When do Aztreonam patents expire, and what generic alternatives are available?
Aztreonam is a drug marketed by Fresenius Kabi Usa, Hikma, and Hospira. and is included in three NDAs.
The generic ingredient in AZTREONAM is aztreonam. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aztreonam profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aztreonam
A generic version of AZTREONAM was approved as aztreonam by FRESENIUS KABI USA on June 18th, 2010.
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Questions you can ask:
- What is the 5 year forecast for AZTREONAM?
- What are the global sales for AZTREONAM?
- What is Average Wholesale Price for AZTREONAM?
Summary for AZTREONAM
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 62 |
| Patent Applications: | 4,746 |
| Drug Prices: | Drug price information for AZTREONAM |
| DailyMed Link: | AZTREONAM at DailyMed |
Recent Clinical Trials for AZTREONAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Meiji Seika Pharma Co., Ltd. | Phase 3 |
| National Cancer Institute (NCI) | Phase 1 |
| Qianfoshan Hospital | N/A |
Pharmacology for AZTREONAM
| Drug Class | Monobactam Antibacterial |
Medical Subject Heading (MeSH) Categories for AZTREONAM
Anatomical Therapeutic Chemical (ATC) Classes for AZTREONAM
US Patents and Regulatory Information for AZTREONAM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | AZTREONAM | aztreonam | INJECTABLE;INJECTION | 065439-002 | Jun 18, 2010 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hospira | AZTREONAM | aztreonam | INJECTABLE;INJECTION | 206517-002 | Nov 8, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | AZTREONAM | aztreonam | INJECTABLE;INJECTION | 065286-001 | Mar 23, 2011 | 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 |
EU/EMA Drug Approvals for AZTREONAM
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Ireland UC | Cayston | aztreonam | EMEA/H/C/000996 Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
Authorised | no | no | no | 2009-09-21 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
