FDA Orange Book · active-ingredient family
Cinacalcet hydrochloride
Cinacalcet hydrochloride: 1 brand, 14 generics; first approved Mar 08, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 14 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
14
Listed patents
2
Next patent expiry
Sep 22, 2026
in 29 d
Brand (NDA) products
Originator applications
- SENSIPARRLDAMGENNDA 02168820043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Discontinued — EQ 60MG BASE TABLET ORAL Discontinued — EQ 90MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (14)
Abbreviated applications
- CINACALCET HYDROCHLORIDESTEVENS JANDA 20436420213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Discontinued — EQ 60MG BASE TABLET ORAL Discontinued — EQ 90MG BASE TABLET ORAL Discontinued — - CINACALCET HYDROCHLORIDEHETERO LABS LTD VANDA 20940320203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Discontinued — EQ 60MG BASE TABLET ORAL Discontinued — EQ 90MG BASE TABLET ORAL Discontinued — - CINACALCET HYDROCHLORIDEDR REDDYSANDA 20836820203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Rx AB EQ 60MG BASE TABLET ORAL Rx AB EQ 90MG BASE TABLET ORAL Rx AB - CINACALCET HYDROCHLORIDECHARTWELL RXANDA 21332520203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Rx AB EQ 60MG BASE TABLET ORAL Rx AB EQ 90MG BASE TABLET ORAL Rx AB - CINACALCET HYDROCHLORIDEACCORD HLTHCAREANDA 21189220203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Rx AB EQ 60MG BASE TABLET ORAL Rx AB EQ 90MG BASE TABLET ORAL Rx AB - CINACALCET HYDROCHLORIDELUPINANDA 21054820193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Discontinued — EQ 60MG BASE TABLET ORAL Discontinued — EQ 90MG BASE TABLET ORAL Discontinued — - CINACALCET HYDROCHLORIDEALKEM LABS LTDANDA 21057020193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Rx AB EQ 60MG BASE TABLET ORAL Rx AB EQ 90MG BASE TABLET ORAL Rx AB - CINACALCET HYDROCHLORIDEWATSON LABS TEVAANDA 20437720183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Rx AB EQ 60MG BASE TABLET ORAL Rx AB EQ 90MG BASE TABLET ORAL Rx AB - CINACALCET HYDROCHLORIDERISINGANDA 20342220183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Discontinued — EQ 60MG BASE TABLET ORAL Discontinued — EQ 90MG BASE TABLET ORAL Discontinued — - CINACALCET HYDROCHLORIDESUN PHARMANDA 20700820183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Discontinued — EQ 60MG BASE TABLET ORAL Rx AB EQ 90MG BASE TABLET ORAL Discontinued — - CINACALCET HYDROCHLORIDEPIRAMALANDA 21020720183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Rx AB EQ 60MG BASE TABLET ORAL Rx AB EQ 90MG BASE TABLET ORAL Rx AB - CINACALCET HYDROCHLORIDESTRIDES PHARMAANDA 20922620183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Rx AB EQ 60MG BASE TABLET ORAL Rx AB EQ 90MG BASE TABLET ORAL Rx AB - CINACALCET HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 20612520183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Rx AB EQ 60MG BASE TABLET ORAL Rx AB EQ 90MG BASE TABLET ORAL Rx AB - CINACALCET HYDROCHLORIDECIPLAANDA 20891520183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30MG BASE TABLET ORAL Rx AB EQ 60MG BASE TABLET ORAL Rx AB EQ 90MG BASE TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7829595 | in 29 d | ProductU-1098 | |
| 9375405 | in 29 d | Product |
Approval history
FDA approval span
First approval
22 yr 9 mo ago
Most recent approval
4 yr 10 mo ago
Approvals span 2004–2021 across 15 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1493%
Cinacalcet hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
