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Generated: May 20, 2019

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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. It is available from four suppliers. 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. Eight suppliers are listed 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
Pharmacology for NDA: 021688
Medical Subject Heading (MeSH) Categories for 021688
Suppliers and Packaging for NDA: 021688
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688 NDA A-S Medication Solutions 50090-3529 50090-3529-0 30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-3529-0)
SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688 NDA State of Florida DOH Central Pharmacy 53808-0577 53808-0577-1 30 TABLET, COATED in 1 BLISTER PACK (53808-0577-1)

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:CLINICAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING.
Regulatory Exclusivity Expiration:Nov 21, 2021
Regulatory Exclusivity Use:TREATMENT OF HYPERCALCEMIA IN ADULT PATIENTS WITH PRIMARY HYPERPARATHYROIDISM FOR WHOM PARATHYROIDECTOMY WOULD BE INDICATED ON THE BASIS OF SERUM CALCIUM LEVELS, BUT WHO ARE UNABLE TO UNDERGO PARATHYROIDECTOMY.
Patent:➤ Sign UpPatent Expiration:Sep 22, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA

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 ➤ Sign Up ➤ Sign Up
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 ➤ Sign Up ➤ Sign Up
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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