AZACTAM Drug Patent Profile
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Which patents cover Azactam, and what generic alternatives are available?
Azactam is a drug marketed by Bristol Myers Squibb and is included in two NDAs.
The generic ingredient in AZACTAM 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 Azactam
A generic version of AZACTAM 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 AZACTAM?
- What are the global sales for AZACTAM?
- What is Average Wholesale Price for AZACTAM?
Summary for AZACTAM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 72 |
| Clinical Trials: | 2 |
| Patent Applications: | 7,737 |
| Drug Prices: | Drug price information for AZACTAM |
| What excipients (inactive ingredients) are in AZACTAM? | AZACTAM excipients list |
| DailyMed Link: | AZACTAM at DailyMed |
Recent Clinical Trials for AZACTAM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 |
| Virginia Commonwealth University | Phase 2 |
| Eastern Virginia Medical School | Phase 2 |
Pharmacology for AZACTAM
| Drug Class | Monobactam Antibacterial |
US Patents and Regulatory Information for AZACTAM
| 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 | 050580-002 | Dec 31, 1986 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bristol Myers Squibb | AZACTAM IN PLASTIC CONTAINER | aztreonam | INJECTABLE;INJECTION | 050632-003 | May 24, 1989 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol Myers Squibb | AZACTAM | aztreonam | INJECTABLE;INJECTION | 050580-003 | Dec 31, 1986 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bristol Myers Squibb | AZACTAM | aztreonam | INJECTABLE;INJECTION | 050580-001 | Dec 31, 1986 | 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 AZACTAM
| 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 |
