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BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

Julphar
Dow
Accenture
Johnson and Johnson
Queensland Health
Medtronic
AstraZeneca
Healthtrust
Harvard Business School
Baxter

Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204734

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NDA 204734 describes FOSRENOL, which is a drug marketed by Shire Dev Llc and Shire Llc and is included in two NDAs. It is available from four suppliers. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the FOSRENOL profile page.

The generic ingredient in FOSRENOL is lanthanum carbonate. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.

Summary for NDA: 204734

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204734

Mechanism of ActionPhosphate Chelating Activity

Suppliers and Packaging for NDA: 204734

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSRENOL
lanthanum carbonate
POWDER;ORAL 204734 NDA Shire US Manufacturing Inc. 54092-256 54092-256-02 9 CARTON in 1 PACKAGE (54092-256-02) > 10 POWDER in 1 CARTON (54092-256-01)
FOSRENOL
lanthanum carbonate
POWDER;ORAL 204734 NDA Shire US Manufacturing Inc. 54092-257 54092-257-02 9 CARTON in 1 CARTON (54092-257-02) > 10 POWDER in 1 CARTON (54092-257-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 750MG BASE
Approval Date:Sep 24, 2014TE:RLD:Yes
Patent:► SubscribePatent Expiration:Oct 26, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TO REDUCE SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
Patent:► SubscribePatent Expiration:Aug 26, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Dec 1, 2030Product Flag?YSubstance Flag?Delist Request?


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Serving 500+ biopharmaceutical companies globally:

Merck
US Army
Cantor Fitzgerald
Chubb
Accenture
Farmers Insurance
Johnson and Johnson
Mallinckrodt
Queensland Health
Daiichi Sankyo

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 verifification 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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