FOSRENOL Drug Patent Profile
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Which patents cover Fosrenol, and what generic alternatives are available?
Fosrenol is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.
This drug has ninety-one 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. Six suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
DrugPatentWatch® 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.
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Questions you can ask:
- What is the 5 year forecast for FOSRENOL?
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Summary for FOSRENOL
International Patents: | 91 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 22 |
Clinical Trials: | 27 |
Drug Prices: | Drug price information for FOSRENOL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FOSRENOL |
What excipients (inactive ingredients) are in FOSRENOL? | FOSRENOL excipients list |
DailyMed Link: | FOSRENOL at DailyMed |
Recent Clinical Trials for FOSRENOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Medical Universtity of Lodz | Phase 4 |
Medical University of Lodz | Phase 4 |
Universitair Ziekenhuis Brussel | Phase 3 |
Pharmacology for FOSRENOL
Drug Class | Phosphate Binder |
Mechanism of Action | Phosphate Chelating Activity |
Paragraph IV (Patent) Challenges for FOSRENOL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FOSRENOL | Oral Powder | lanthanum carbonate | 750 mg and 1000 mg | 204734 | 1 | 2015-11-25 |
FOSRENOL | Chewable Tablet | lanthanum carbonate | 500 mg, 750 mg and 1000 mg | 021468 | 3 | 2008-10-27 |
US Patents and Regulatory Information for FOSRENOL
FOSRENOL is protected by four US patents.
Patents protecting FOSRENOL
Stabilized lanthanum carbonate compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
Pharmaceutical formulation comprising lanthanum compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Capsule and powder formulations containing lanthanum compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Capsule and powder formulations containing lanthanum compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-002 | Sep 24, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-004 | Nov 23, 2005 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-001 | Sep 24, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-002 | Oct 26, 2004 | 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 |
Expired US Patents for FOSRENOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-004 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-002 | Sep 24, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-002 | Oct 26, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-001 | Oct 26, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FOSRENOL
See the table below for patents covering FOSRENOL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2010248247 | PHARMACEUTICAL FORMULATION COMPRISING LANTHANUM COMPOUND | ⤷ Sign Up |
Portugal | 2792363 | ⤷ Sign Up | |
Poland | 2792363 | ⤷ Sign Up | |
Norway | 342559 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FOSRENOL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0817639 | SPC/GB06/036 | United Kingdom | ⤷ Sign Up | SPC/GB06/036: 20061027 |
0817639 | PA2008005,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 |
0817639 | PA2008005 | Lithuania | ⤷ Sign Up | PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |