CAYSTON Drug Patent Profile
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When do Cayston patents expire, and when can generic versions of Cayston launch?
Cayston is a drug marketed by Gilead and is included in one NDA.
The generic ingredient in CAYSTON 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 Cayston
A generic version of CAYSTON was approved as aztreonam by FRESENIUS KABI USA on June 18th, 2010.
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Summary for CAYSTON
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 73 |
| Clinical Trials: | 6 |
| Patent Applications: | 7,170 |
| Drug Prices: | Drug price information for CAYSTON |
| What excipients (inactive ingredients) are in CAYSTON? | CAYSTON excipients list |
| DailyMed Link: | CAYSTON at DailyMed |
Recent Clinical Trials for CAYSTON
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Dundee | Phase 2 |
| Gilead Sciences | Phase 2 |
| Children's Hospital & Research Center Oakland | Phase 4 |
US Patents and Regulatory Information for CAYSTON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for CAYSTON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for CAYSTON
| 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 |
International Patents for CAYSTON
See the table below for patents covering CAYSTON around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 2301524 | ⤷ Sign Up | |
| Australia | 2012202089 | ⤷ Sign Up | |
| Norway | 2011001 | ⤷ Sign Up | |
| Portugal | 2158901 | ⤷ Sign Up | |
| Spain | 2360692 | ⤷ Sign Up | |
| Denmark | 1353647 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CAYSTON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1353647 | 27/2011 | Austria | ⤷ Sign Up | PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921 |
| 1353647 | 365 | Finland | ⤷ Sign Up | |
| 2158901 | C 2018 012 | Romania | ⤷ Sign Up | PRODUCT NAME: AZTREONAM LIZINA; NATIONAL AUTHORISATION NUMBER: EU/1/09/543/001; DATE OF NATIONAL AUTHORISATION: 20090921; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/09/543/001; DATE OF FIRST AUTHORISATION IN EEA: 20090921 |
| 2158901 | 2018C/001 | Belgium | ⤷ Sign Up | PRODUCT NAME: CAYSTON - AZTREONAM; AUTHORISATION NUMBER AND DATE: EU/1/09/543/001 20090923 |
| 1353647 | 2011/024 | Ireland | ⤷ Sign Up | PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923 |
| 2158901 | 122018000044 | Germany | ⤷ Sign Up | PRODUCT NAME: AZTREONAMIYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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