SENSIPAR — FDA application NDA021688

Application NDA021688 · type NDA · FDA status: approved · original approval 2004-03-08

Listed sponsor: AMGEN · AMGN company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	SENSIPAR	CINACALCET HYDROCHLORIDE	TABLET	ORAL	EQ 30MG BASE	Discontinued	not listed	Yes
002	SENSIPAR	CINACALCET HYDROCHLORIDE	TABLET	ORAL	EQ 60MG BASE	Discontinued	not listed	Yes
003	SENSIPAR	CINACALCET HYDROCHLORIDE	TABLET	ORAL	EQ 90MG BASE	Discontinued	not listed	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Listing	Product	Descriptive date	Flags/code
Patent 7829595	001	listed patent expiry date: 2026-09-22	drug product, U-1098
Patent 7829595	002	listed patent expiry date: 2026-09-22	drug product, U-1098
Patent 7829595	003	listed patent expiry date: 2026-09-22	drug product, U-1098
Patent 9375405	001	listed patent expiry date: 2026-09-22	drug product
Patent 9375405	002	listed patent expiry date: 2026-09-22	drug product
Patent 9375405	003	listed patent expiry date: 2026-09-22	drug product

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

CINACALCET HYDROCHLORIDE · UNII 1K860WSG25 · lmmol compound QANQWUQOEJZMLL-PKLMIRHRSA-N · CHEMBL1200776

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.