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FOSRENOL Drug Profile
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» See Plans and PricingWhich patents cover Fosrenol, and what generic alternatives are available?
Fosrenol is a drug marketed by Shire Dev Llc and Shire Llc and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.
This drug has ninety patent family members in thirty-one countries.
The generic ingredient in FOSRENOL is lanthanum carbonate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
US ANDA Litigation and Generic Entry Outlook for Fosrenol
A generic version of FOSRENOL was approved as lanthanum carbonate by NATCO PHARMA LTD on August 11th, 2017.
Summary for FOSRENOL
| International Patents: | 90 |
| US Patents: | 4 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 21 |
| Clinical Trials: | 25 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FOSRENOL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FOSRENOL |
| DailyMed Link: | FOSRENOL at DailyMed |
Recent Clinical Trials for FOSRENOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Universitair Ziekenhuis Brussel | Phase 3 |
| Astellas Pharma Inc | Phase 1 |
| FibroGen | Phase 1 |
Recent Litigation for FOSRENOL
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Shire Development LLC v. Alkem Laboratories Ltd. | 2016-08-24 |
| Shire Development LLC v. Apotex, Inc. | 2015-11-12 |
| SHIRE DEVELOPMENT LLC v. INVAGEN PHARMACEUTICALS, INC. | 2015-01-20 |
Pharmacology for FOSRENOL
| Drug Class | Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Paragraph IV (Patent) Challenges for FOSRENOL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FOSRENOL | POWDER;ORAL | lanthanum carbonate | 204734 | 2015-11-25 |
| FOSRENOL | TABLET, CHEWABLE;ORAL | lanthanum carbonate | 021468 | 2008-10-27 |
US Patents and Regulatory Information for FOSRENOL
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-004 | Nov 23, 2005 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Shire Dev Llc | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-001 | Sep 24, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-002 | Oct 26, 2004 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-004 | Nov 23, 2005 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-003 | Nov 23, 2005 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Shire Dev Llc | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-002 | Sep 24, 2014 | 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 |
Expired US Patents for FOSRENOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-004 | Nov 23, 2005 | Start Trial | Start Trial |
| Shire Dev Llc | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-002 | Sep 24, 2014 | Start Trial | Start Trial |
| Shire Dev Llc | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-001 | Sep 24, 2014 | Start Trial | Start Trial |
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-002 | Oct 26, 2004 | Start Trial | Start Trial |
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-003 | Nov 23, 2005 | Start Trial | Start Trial |
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-001 | Oct 26, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FOSRENOL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 817639 | Start Trial |
| South Africa | 200602213 | Start Trial |
| Hong Kong | 1084338 | Start Trial |
| Australia | 2011336602 | Start Trial |
| Cyprus | 1110241 | Start Trial |
| Argentina | 056609 | Start Trial |
| Norway | 20082538 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for FOSRENOL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0817639 | PA2008005,C0817639 | Lithuania | Start Trial | 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 |
| 0817639 | PA2008005 | Lithuania | Start Trial | PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319 |
| 0817639 | SPC/GB06/036 | United Kingdom | Start Trial | SPC/GB06/036: 20061027 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
