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 one supplier. 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. Sixteen 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	Amgen Inc	55513-073	55513-073-30	30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-073-30)
SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688	NDA	Amgen Inc	55513-074	55513-074-30	30 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-074-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 30MG BASE
Approval Date:	Mar 8, 2004	TE:		RLD:	Yes
Patent:	7,829,595	Patent Expiration:	Sep 22, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA
Patent:	9,375,405	Patent Expiration:	Sep 22, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 60MG BASE
Approval Date:	Mar 8, 2004	TE:		RLD:	Yes
Patent:	7,829,595	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	021688-003	Mar 8, 2004	6,211,244	⤷ Get Started Free
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	6,011,068	⤷ Get Started Free
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	6,313,146	⤷ Get Started Free
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	6,011,068	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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