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Serving 500+ biopharmaceutical companies globally:

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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021179

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NDA 021179 describes RENAGEL, which is a drug marketed by Genzyme and is included in two NDAs. It is available from five suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the RENAGEL profile page.

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

Summary for NDA: 021179

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

Pharmacology for NDA: 021179

Mechanism of ActionPhosphate Chelating Activity

Suppliers and Packaging for NDA: 021179

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RENAGEL
sevelamer hydrochloride
TABLET;ORAL 021179 NDA Atlantic Biologicals Corps 17856-0021 17856-0021-2 1 TABLET in 1 POUCH (17856-0021-2)
RENAGEL
sevelamer hydrochloride
TABLET;ORAL 021179 NDA DOH CENTRAL PHARMACY 53808-0777 53808-0777-1 30 TABLET in 1 BLISTER PACK (53808-0777-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jul 12, 2000TE:RLD:Yes
Patent:6,733,780Patent Expiration:Oct 18, 2020Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Jul 12, 2000TE:RLD:Yes
Patent:6,733,780Patent Expiration:Oct 18, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021179

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 20007,014,846► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-002Jul 12, 20005,496,545► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-002Jul 12, 20005,667,775► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 20005,496,545► Subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 20007,459,151► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
Moodys
Queensland Health
Baxter
Healthtrust
Argus Health
Fish and Richardson
Colorcon
UBS

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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