Aztreonam - Generic Drug Details
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What are the generic drug sources for aztreonam and what is the scope of patent protection?
Aztreonam
is the generic ingredient in four branded drugs marketed by Gilead, Bristol Myers Squibb, Fresenius Kabi Usa, Hikma, and Hospira, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are eight drug master file entries for aztreonam. Four suppliers are listed for this compound.
Summary for aztreonam
| US Patents: | 0 |
| Tradenames: | 4 |
| Applicants: | 5 |
| NDAs: | 6 |
| Drug Master File Entries: | 8 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 62 |
| Patent Applications: | 7,456 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for aztreonam |
| What excipients (inactive ingredients) are in aztreonam? | aztreonam excipients list |
| 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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | AZACTAM | aztreonam | INJECTABLE;INJECTION | 050580-001 | Dec 31, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fresenius Kabi Usa | AZTREONAM | aztreonam | INJECTABLE;INJECTION | 065439-003 | Jun 18, 2010 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bristol Myers Squibb | AZACTAM IN PLASTIC CONTAINER | aztreonam | INJECTABLE;INJECTION | 050632-002 | May 24, 1989 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for aztreonam
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
Make Better Decisions: Try a trial or see plans & pricing
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. 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.
ISSN: 2162-2639
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