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Last Updated: January 21, 2021

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Details for New Drug Application (NDA): 021688

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NDA 021688 describes SENSIPAR, which is a drug marketed by Amgen and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SENSIPAR profile page.

The generic ingredient in SENSIPAR is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
Summary for 021688
Tradename:SENSIPAR
Applicant:Amgen
Ingredient:cinacalcet hydrochloride
Patents:2
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021688
Paragraph IV (Patent) Challenges for 021688
Tradename Dosage Ingredient NDA Submissiondate
SENSIPAR TABLET;ORAL cinacalcet hydrochloride 021688 2008-03-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 30MG BASE
Approval Date:Mar 8, 2004TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 23, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Nov 21, 2021
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:Sep 22, 2026Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021688

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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