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FDA Orange Book · active-ingredient family

Zoledronic acid

Zoledronic acid is approved as 4 brand and 37 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZOLEDRONIC ACID · NDA 203231

4

Brand (NDA)

37

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution

ProductApplicantApplicationTEApproved
ZOLEDRONIC ACIDRLDINFORLIFENDA 203231APAug 02, 2013
RECLASTRLDSANDOZNDA 021817APApr 16, 2007
ZOMETARLD×3NOVARTISNDA 021223—Aug 20, 2001
ZOLEDRONIC ACIDHOSPIRANDA 204016—Dec 28, 2015

Generic (ANDA) products (37)

ProductApplicantApplicationTEApproved
ZOLEDRONIC ACIDGLANDANDA 219984APFeb 05, 2026
ZOLEDRONIC ACIDMEITHEALANDA 213371APJun 05, 2023
ZOLEDRONIC ACIDNOVAST LABSANDA 208968—Feb 19, 2020
ZOLEDRONIC ACIDGLANDANDA 209578APAug 08, 2019
ZOLEDRONIC ACIDSHILPAANDA 208513—May 15, 2019
ZOLEDRONIC ACIDDR REDDYSANDA 204344—Nov 19, 2018
ZOLEDRONICGLANDANDA 205749APJun 29, 2018
ZOLEDRONIC ACIDBPI LABSANDA 207341APDec 29, 2017
ZOLEDRONIC ACIDEUGIA PHARMAANDA 209125—Dec 08, 2017
ZOLEDRONIC ACIDAMNEALANDA 210174APOct 27, 2017
ZOLEDRONIC ACIDMYLAN LABS LTDANDA 205254APOct 27, 2017
ZOLEDRONIC ACIDMYLAN LABS LTDANDA 203841APFeb 14, 2017
ZOLEDRONIC ACIDACCORD HLTHCAREANDA 205279APNov 28, 2016
ZOLEDRONIC ACIDEUGIA PHARMAANDA 207751—Sep 26, 2016
ZOLEDRONIC ACIDGLANDANDA 204217APAug 18, 2016
ZOLEDRONIC ACIDAPOTEXANDA 204367—Dec 24, 2015
ZOLEDRONIC ACIDFRESENIUS KABI USAANDA 091516APApr 23, 2015
ZOLEDRONIC ACIDHOSPIRAANDA 090621—Mar 19, 2015
ZOLEDRONIC ACIDSAGENT PHARMS INCANDA 091493APNov 24, 2014
ZOLEDRONIC ACIDUSVANDA 202923APSep 04, 2014
ZOLEDRONIC ACIDEPIC PHARMA LLCANDA 200918APAug 21, 2014
ZOLEDRONIC ACIDEPIC PHARMA LLCANDA 202548APMay 22, 2014
ZOLEDRONIC ACIDINFORLIFEANDA 202828APSep 23, 2013
ZOLEDRONIC ACIDCHARTWELL RXANDA 202163APAug 05, 2013
ZOLEDRONIC ACIDGLANDANDA 202930APAug 05, 2013
ZOLEDRONIC ACIDHIKMA FARMACEUTICAANDA 202182APJun 03, 2013
ZOLEDRONIC ACIDCHARTWELL RXANDA 202571APMay 07, 2013
ZOLEDRONIC ACIDHOSPIRA INCANDA 202837—Apr 05, 2013
ZOLEDRONIC ACIDAVET LIFESCIENCESANDA 201801—Mar 29, 2013
ZOLEDRONIC ACIDDR REDDYS LABS LTDANDA 091363APMar 29, 2013
ZOLEDRONIC ACIDAVET LIFESCIENCESANDA 201783APMar 12, 2013
ZOLEDRONIC ACIDACTAVIS INCANDA 202472—Mar 04, 2013
ZOLEDRONIC ACIDBRECKENRIDGEANDA 091170—Mar 04, 2013
ZOLEDRONIC ACIDDR REDDYS LABS LTDANDA 091186APMar 04, 2013
ZOLEDRONIC ACIDMYLAN LABS LTDANDA 202650APMar 04, 2013
ZOLEDRONIC ACIDSUN PHARMA GLOBALANDA 090018—Mar 04, 2013
ZOLEDRONIC ACIDSUN PHARMA GLOBALANDA 202746—Mar 04, 2013

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7932241Feb 05, 2028in 1 yr 8 mo
Product
7932241*PEDAug 05, 2028in 2 yr 2 mo

Zoledronic acid — frequently asked questions

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

Agent CTA Background

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