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 eighty-nine 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.
Summary for FOSRENOL
| International Patents: | 89 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 21 |
| Clinical Trials: | 27 |
| Patent Applications: | 196 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for FOSRENOL
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
Pharmaceutical formulation comprising lanthanum compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Capsule and powder formulations containing lanthanum compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Capsule and powder formulations containing lanthanum compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-004 | Nov 23, 2005 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-001 | Sep 24, 2014 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-002 | Oct 26, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-004 | Nov 23, 2005 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-002 | Oct 26, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-002 | Sep 24, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-001 | Oct 26, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-004 | Nov 23, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-001 | Sep 24, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Argentina | 056609 | COMPOSICIONES ESTABILIZADAS DE CARBONATO DE LANTANO | ⤷ Try a Trial |
| Germany | 202004021169 | ⤷ Try a Trial | |
| Japan | 2022027979 | ランタン化合物を含むカプセル製剤及び粉末製剤 (CAPSULE AND POWDER FORMULATIONS CONTAINING LANTHANUM COMPOUNDS) | ⤷ Try a Trial |
| Finland | U20060387 | ⤷ Try a Trial | |
| Australia | 2009202429 | Pharmaceutical formulation comprising lanthanum compounds | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FOSRENOL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0817639 | PA2008005,C0817639 | Lithuania | ⤷ Try a 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 | ⤷ Try a 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 | ⤷ Try a Trial | SPC/GB06/036: 20061027 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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.
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