Serving 500+ biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving 500+ biopharmaceutical companies globally:
Generated: June 23, 2017
What is the patent landscape for Fosrenol, and when can generic versions of Fosrenol launch?
Fosrenol is a drug marketed by Shire Dev Llc and Shire Llc and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.| Patents: | 5 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 3 |
| Bulk Api Vendors: see list | 17 |
| Clinical Trials: see list | 23 |
| Patent Applications: see list | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | FOSRENOL at DailyMed |
| Drug Class | Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Shire Dev Llc | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-002 | Sep 24, 2014 | RX | Yes | Yes | 9,023,397 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-003 | Nov 23, 2005 | RX | Yes | No | 7,465,465 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Shire Dev Llc | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-001 | Sep 24, 2014 | RX | Yes | No | 8,980,327 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Shire Dev Llc | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-002 | Sep 24, 2014 | RX | Yes | Yes | 5,968,976 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-001 | Oct 26, 2004 | DISCN | No | No | 7,465,465 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| lanthanum carbonate | Oral Powder | 750 mg and 1000 mg | Fosrenol | 11/25/2015 |
| lanthanum carbonate | Chewable Tablet | 500 mg, 750 mg and 1000 mg | Fosrenol | 10/27/2008 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,263,119 | Capsule formulations containing lanthanum compounds | ► Subscribe | |||||||||||||||||||||||||||
| 8,697,132 | Capsule and powder formulations containing lanthanum compounds | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Portugal | 2172205 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | PI0413394 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2792363 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2536959 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | 9707334 | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB06/036 | United Kingdom | ► Subscribe | SPC/GB06/036: 20061027 | ||||||||||||||||||||||||||
| 2008005,C0817639 | Lithuania | ► Subscribe | PRODUCT NAME: LANTANO KARBONATO HIDRATAS; NAT. REGISTRATION NO/DATE: LT/1/07/0776/001-021 20071003; FIRST REGISTRATION: 17192, 2004-03-19 ; 18466, 2004-03-19; 21073, 2004-10-19; 21074 20041029 | ||||||||||||||||||||||||||
| 2008005 | Lithuania | ► Subscribe | PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319 | ||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
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.
Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639
Follow DrugPatentWatch:
Join the 21,675 other biopharmaceutical professionals who get our Drug Patent Expiration Alerts:
