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. Five 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.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for CAYSTON?
- What are the global sales for CAYSTON?
- What is Average Wholesale Price for CAYSTON?
Summary for CAYSTON
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 6 |
| 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 |
|---|---|
| Gilead Sciences | Phase 2 |
| University of Dundee | Phase 2 |
| Gilead Sciences | 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 | ⤷ 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 |
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 | 7,208,141 | ⤷ Start Trial |
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | 7,427,633 | ⤷ Start Trial |
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | 8,399,496 | ⤷ Start Trial |
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | 7,214,364 | ⤷ Start Trial |
| >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/000996Cayston 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 |
|---|---|---|---|
| Argentina | 053305 | PROCESO PARA LA FABRICACION DE SOLUCIONES MASIVAS Y LISINATO DE AZTREONAM ALFA PURO LIOFILIZADO | ⤷ Start Trial |
| Austria | 502623 | ⤷ Start Trial | |
| Australia | 2002231244 | ⤷ Start Trial | |
| Australia | 2004257632 | ⤷ Start Trial | |
| Australia | 2009233632 | ⤷ Start Trial | |
| Australia | 2012202089 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CAYSTON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1353647 | C300492 | Netherlands | ⤷ Start Trial | PRODUCT NAME: AZTREONAM, NIET IN EEN SAMENSTELLING MET ARGININE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN AZTREONAM, ANDERS DAN EEN ARGININEZOUT, IN HET BIJZONDER ALS AZTREONAMLYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090921 |
| 1353647 | 91851 | Luxembourg | ⤷ Start Trial | 91851, EXPIRES: 20240921 |
| 1353647 | CA 2011 00021 | Denmark | ⤷ Start Trial | |
| 1353647 | 365 | Finland | ⤷ Start Trial | |
| 1353647 | 11C0030 | France | ⤷ Start Trial | PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/543/001 DU 20090921; REGISTRATION NO/DATE AT EEC: EU/1/09/543/001 DU 20090921 |
| 1353647 | 1190027-1 | Sweden | ⤷ Start Trial | MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/09/543/001, 2009-09-23; PERIOD OF VALIDITY (FROM - UNTIL): 2021-12-21 - 2024-09- 22 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |


