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 two 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. Twenty 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

Pharmacology for NDA: 021688

Mechanism of Action	Increased Calcium-sensing Receptor Sensitivity

Medical Subject Heading (MeSH) Categories for 021688

Calcimimetic Agents

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	A-S Medication Solutions	50090-7096	50090-7096-0	30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-7096-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 30MG BASE
Approval Date:	Mar 8, 2004	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 22, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA
Patent:	⤷ Sign Up	Patent Expiration:	Sep 22, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 60MG BASE
Approval Date:	Mar 8, 2004	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 22, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA

Expired US Patents for NDA 021688

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

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