FOSRENOL Drug Patent Profile
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When do Fosrenol patents expire, and what generic alternatives are available?
Fosrenol is a drug marketed by Takeda Pharms Usa and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in FOSRENOL is lanthanum carbonate. Seven 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?
- What are the global sales for FOSRENOL?
- What is Average Wholesale Price for FOSRENOL?
Summary for FOSRENOL
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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 two US patents.
| 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 | 8,980,327 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-002 | Oct 26, 2004 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | POWDER;ORAL | 204734-001 | Sep 24, 2014 | RX | Yes | No | 8,980,327 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Takeda Pharms Usa | FOSRENOL | lanthanum carbonate | TABLET, CHEWABLE;ORAL | 021468-003 | Nov 23, 2005 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for FOSRENOL
See the table below for patents covering FOSRENOL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 209923 | ⤷ Start Trial | |
| Australia | 4951496 | ⤷ Start Trial | |
| Australia | 702073 | ⤷ Start Trial | |
| Brazil | 9607926 | ⤷ Start 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 | Lithuania | ⤷ Start Trial | PRODCUT NAME: LANTANO KARBONATO HIDRATAS; NAT. REG. DATE/NO: LT/1/07/0776/001-021; FIRST REG. DATE: 20040319 |
| 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 | SPC/GB06/036 | United Kingdom | ⤷ Start 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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