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FDA Orange Book · active-ingredient family

Cinacalcet hydrochloride

Cinacalcet hydrochloride is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SENSIPAR · NDA 021688

1

Brand (NDA)

14

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
SENSIPARRLD×3AMGENNDA 021688—Mar 08, 2004

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
CINACALCET HYDROCHLORIDE×3STEVENS JANDA 204364—Dec 02, 2021
CINACALCET HYDROCHLORIDE×3HETERO LABS LTD VANDA 209403—Oct 07, 2020
CINACALCET HYDROCHLORIDE×3DR REDDYSANDA 208368ABSep 18, 2020
CINACALCET HYDROCHLORIDE×3CHARTWELL RXANDA 213325ABMay 18, 2020
CINACALCET HYDROCHLORIDE×3ACCORD HLTHCAREANDA 211892ABMay 15, 2020
CINACALCET HYDROCHLORIDE×3LUPINANDA 210548—Jun 28, 2019
CINACALCET HYDROCHLORIDE×3ALKEM LABS LTDANDA 210570ABMay 17, 2019
CINACALCET HYDROCHLORIDE×3WATSON LABS TEVAANDA 204377ABDec 27, 2018
CINACALCET HYDROCHLORIDE×3RISINGANDA 203422—Oct 16, 2018
CINACALCET HYDROCHLORIDE×3SUN PHARMANDA 207008—Oct 11, 2018
CINACALCET HYDROCHLORIDE×3PIRAMALANDA 210207ABAug 01, 2018
CINACALCET HYDROCHLORIDE×3STRIDES PHARMAANDA 209226ABApr 30, 2018
CINACALCET HYDROCHLORIDE×3AUROBINDO PHARMA LTDANDA 206125ABMar 08, 2018
CINACALCET HYDROCHLORIDE×3CIPLAANDA 208915ABMar 08, 2018

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7829595Sep 22, 2026in 3 mo
ProductU-1098
9375405Sep 22, 2026in 3 mo
Product

Cinacalcet hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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