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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022318

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NDA 022318 describes RENVELA, which is a drug marketed by Genzyme and is included in two NDAs. It is available from seven suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the RENVELA profile page.

The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

Summary for NDA: 022318

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

Pharmacology for NDA: 022318

Mechanism of ActionPhosphate Chelating Activity

Suppliers and Packaging for NDA: 022318

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL 022318 NDA Genzyme Corporation 58468-0131 58468-0131-2 90 PACKET in 1 CARTON (58468-0131-2) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1)
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL 022318 NDA Genzyme Corporation 58468-0131 58468-0131-4 90 PACKET in 1 CARTON (58468-0131-4) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength800MG/PACKET
Approval Date:Aug 12, 2009TE:ABRLD:Yes
Patent:9,095,509Patent Expiration:Dec 6, 2030Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Nov 25, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength2.4GM/PACKET
Approval Date:Feb 18, 2009TE:ABRLD:Yes
Patent:9,095,509Patent Expiration:Dec 6, 2030Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022318

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 20096,858,203► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-001Aug 12, 20096,509,013► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 20097,459,151► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 20095,496,545► Subscribe
Genzyme
RENVELA
sevelamer carbonate
FOR SUSPENSION;ORAL022318-002Feb 18, 20097,014,846► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Moodys
Mallinckrodt
UBS
Julphar
Teva
Chubb
Novartis
Harvard Business School
Merck
Argus Health

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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