DrugPatentWatch Database Preview
FOSRENOL Drug Profile
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 four patents protecting this drug and two Paragraph IV challenges.
This drug has eighty-six 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.
Summary for FOSRENOL
| International Patents: | 86 |
| 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 |
Synonyms for FOSRENOL
| 0M78EU4V9H |
| 14475-16-2 |
| 587-26-8 |
| AC1L52T0 |
| ACMC-1BB7U |
| C3La2O9 |
| Carbonic acid, lanthanum(3+) salt (3:2) |
| Carbonic acid,lanthanum(3+) salt (3:2) |
| Carbonic acid,lanthanum(3+) salt (3:2), hydrate (9CI) |
| CTK5A8757 |
| DB06792 |
| Dilanthanum tricarbonate |
| EC 209-599-5 |
| EINECS 209-599-5 |
| Foznol |
| HSDB 7758 |
| Lanthanum (III) carbonate |
| Lanthanum Carbonate |
| lanthanum carbonate (2:3) |
| Lanthanum carbonate anhydrous |
| Lanthanum sesquicarbonate |
| Lanthanum(3 ) carbonate |
| Lanthanum(3+) carbonate |
| lanthanum(3+) tricarbonate |
| lanthanum(iii) carbonate |
| LS-186384 |
| NZPIUJUFIFZSPW-UHFFFAOYSA-H |
| Phosbloc |
| 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 | 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 | ||
| >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 | 021468-003 | 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 Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-001 | Oct 26, 2004 | 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 | 021468-004 | Nov 23, 2005 | Start Trial | Start Trial |
| Shire Llc | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-002 | Oct 26, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for FOSRENOL
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Oral Powder | 750 mg and 1000 mg | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Chewable Tablet | 500 mg, 750 mg and 1000 mg | ➤ Subscribe | Start Trial |
International Patents for FOSRENOL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1871018 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2012075194 | Start Trial |
| Finland | U20060387 | Start Trial |
| Israel | 190858 | Start Trial |
| Poland | 2792363 | Start Trial |
| Australia | 2009202429 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
