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Generated: September 20, 2017
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.| Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 5 |
| Clinical Trials: see list | 4 |
| Patent Applications: see list | 5,097 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | CAYSTON at DailyMed |
| 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 | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Gilead | CAYSTON | aztreonam | FOR SOLUTION;INHALATION | 050814-001 | Feb 22, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,660,249 | Inhalable dry powder aztreonam for treatment and prevention of pulmonary bacterial infections | ► Subscribe | |||||||||||||||||||||||||||
| 9,533,000 | Inhalable aztreonam for treatment and prevention of pulmonary bacterial infections | ► Subscribe | |||||||||||||||||||||||||||
| 9,345,663 | Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections | ► Subscribe | |||||||||||||||||||||||||||
| 8,841,286 | Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections | ► Subscribe | |||||||||||||||||||||||||||
| 7,138,419 | Process for manufacturing bulk solutions and a lyophilized pure .alpha.-aztreonam lysinate | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2014271333 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 1641436 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2406405 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 329643 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2012202089 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4646489 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 2301524 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2017200384 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2360692 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 2011001 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 11/024 | Ireland | ► Subscribe | PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923 | ||||||||||||||||||||||||||
| C0030 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 851 | Luxembourg | ► Subscribe | 91851, EXPIRES: 20240921 | ||||||||||||||||||||||||||
| 5 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| 2011 00021 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 90027-1 | Sweden | ► Subscribe | PRODUCT NAME: AZTREONAMLYSIN; REG. NO/DATE: EU/1/09/543/01 20090921 | ||||||||||||||||||||||||||
| 1353647/01 | Switzerland | ► Subscribe | PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010 | ||||||||||||||||||||||||||
| 00492 | Netherlands | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C/GB11/049 | United Kingdom | ► Subscribe | PRODUCT NAME: AZTREONAM LYSINE; REGISTERED: UK EU/1/09/543/001 20090921 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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