Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Express Scripts
AstraZeneca
Dow
Johnson and Johnson

Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021179

See Plans and Pricing

« Back to Dashboard

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. Seven suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.
Summary for 021179
Tradename:RENAGEL
Applicant:Genzyme
Ingredient:sevelamer hydrochloride
Patents:1
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 AUTHORIZED GENERIC Winthrop U.S. 0955-1048 0955-1048-18 180 TABLET, FILM COATED in 1 BOTTLE (0955-1048-18)
RENAGEL sevelamer hydrochloride TABLET;ORAL 021179 NDA DOH CENTRAL PHARMACY 53808-0777 53808-0777-1 30 TABLET in 1 BLISTER PACK (53808-0777-1)
Paragraph IV (Patent) Challenges for 021179
Tradename Dosage Ingredient NDA Submissiondate
RENAGEL TABLET;ORAL sevelamer hydrochloride 021179 2008-05-22

Profile for product number 001

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

Profile for product number 002

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

Expired US Patents for NDA 021179

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000   Start Trial   Start Trial
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Express Scripts
Colorcon
Mallinckrodt
McKesson

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.