DrugPatentWatch Database Preview
FOSRENOL Drug Profile
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When do Fosrenol patents expire, 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.
This drug has one hundred and twenty-one patent family members in thirty-five countries.
The generic ingredient in FOSRENOL is lanthanum carbonate. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
Summary for FOSRENOL
| International Patents: | 121 |
| US Patents: | 5 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 18 |
| Clinical Trials: | 24 |
| Patent Applications: | 1 |
| 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 |
Pharmacology for FOSRENOL
| Drug Class | Phosphate Binder |
| Mechanism of Action | Phosphate Chelating Activity |
Synonyms for FOSRENOL
| 0M78EU4V9H |
| 587-26-8 |
| AC1L52T0 |
| ACMC-1BB7U |
| C3La2O9 |
| Carbonic acid, lanthanum(3+) salt (3:2) |
| Carbonic acid,lanthanum(3+) salt (3:2) |
| CTK5A8757 |
| D0H1LO |
| DB06792 |
| Dilanthanum tricarbonate |
| EINECS 209-599-5 |
| Foznol |
| HSDB 7758 |
| IN002128 |
| IN016806 |
| Lanthanum (III) carbonate |
| Lanthanum Carbonate |
| lanthanum carbonate (2:3) |
| Lanthanum carbonate anhydrous |
| Lanthanum sesquicarbonate |
| Lanthanum(3 ) carbonate |
| Lanthanum(3+) carbonate |
| lanthanum(3+) tricarbonate |
| LANTHANUMCARBONATE |
| LS-186384 |
| NZPIUJUFIFZSPW-UHFFFAOYSA-H |
| Phosbloc |
| Phosphate binding agent, Shire/Johnson Matthey |
| Project Lambda, Shire/Johnson Matthey |
| TC-166469 |
| UNII-0M78EU4V9H |
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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-003 | Nov 23, 2005 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Shire Dev Llc | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-001 | Sep 24, 2014 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Shire Dev Llc | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-002 | Sep 24, 2014 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-001 | Oct 26, 2004 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-003 | Nov 23, 2005 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for FOSRENOL
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Oral Powder | 750 mg and 1000 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Chewable Tablet | 500 mg, 750 mg and 1000 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for FOSRENOL
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 | ➤ Sign Up |
| 8,697,132 | Capsule and powder formulations containing lanthanum compounds | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for FOSRENOL
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Brazil | PI0619673 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2007054782 | ➤ Sign Up |
| Poland | 184315 | ➤ Sign Up |
| South Africa | 9602369 | ➤ Sign Up |
| Spain | 2532389 | ➤ Sign Up |
| Hong Kong | 1008182 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for FOSRENOL
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2008005 | Lithuania | ➤ Sign Up | PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319 |
| 2008005,C0817639 | Lithuania | ➤ Sign Up | 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 |
| C/GB06/036 | United Kingdom | ➤ Sign Up | SPC/GB06/036: 20061027 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
