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CAYSTON Drug Profile
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Which patents cover Cayston, and when can generic versions of Cayston launch?
Cayston is a drug marketed by Gilead and is included in one NDA. There are four patents protecting this drug.
This drug has fifty-six patent family members in twenty-one countries.
The generic ingredient in CAYSTON is aztreonam. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aztreonam profile page.
US ANDA Litigation and Generic Entry Outlook for Cayston
A generic version of CAYSTON was approved as aztreonam by FRESENIUS KABI USA on January 24th, 2020.
Summary for CAYSTON
| International Patents: | 56 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 5 |
| Clinical Trials: | 5 |
| Patent Applications: | 5,971 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CAYSTON |
| 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 | Y | Start Trial | |||
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for CAYSTON
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1114621 | Start Trial |
| Australia | 2012202089 | Start Trial |
| Brazil | PI0411949 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2005007132 | Start Trial |
| European Patent Office | 1353647 | Start Trial |
| Japan | 4646489 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CAYSTON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1353647 | 27/2011 | Austria | Start Trial | PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921 |
| 1353647 | CA 2011 00021 | Denmark | Start Trial | |
| 1353647 | 300492 | Netherlands | Start Trial | PRODUCT NAME: AZTREONAMLYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923 |
| 2158901 | 122018000042 | Germany | Start Trial | PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921 |
| 1353647 | 91851 | Luxembourg | Start Trial | 91851, EXPIRES: 20240921 |
| 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 |
