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FDA Orange Book · active-ingredient family

Doxorubicin hydrochloride

Doxorubicin hydrochloride is approved as 3 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DOXIL (LIPOSOMAL) · NDA 050718

3

Brand (NDA)

27

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, injectable, liposomal

ProductApplicantApplicationTEApproved
DOXIL (LIPOSOMAL)RLD×2BAXTER HLTHCARE CORPNDA 050718ABNov 17, 1995
DOXORUBICIN HYDROCHLORIDERLD×3PFIZERNDA 050629APDec 23, 1987
DOXORUBICIN HYDROCHLORIDE×4PFIZERNDA 050467—Approved Prior to Jan 1, 1982

Generic (ANDA) products (27)

ProductApplicantApplicationTEApproved
DOXORUBICIN HYDROCHLORIDE×2QILU PHARM HAINANANDA 219881ABFeb 03, 2026
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)×2ALEMBICANDA 219199ABJun 27, 2025
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)×2LUPINANDA 215178ABJul 16, 2024
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)×2BAXTER HLTHCARE CORPANDA 212219ABOct 19, 2022
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)×2AYANA PHARMA LTDANDA 207228ABOct 12, 2021
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)×2ZYDUS LIFESCIENCESANDA 212299ABSep 10, 2020
DOXORUBICIN HYDROCHLORIDEHISUN PHARM HANGZHOUANDA 206062—May 13, 2019
DOXORUBICIN HYDROCHLORIDEGLANDANDA 209825APAug 11, 2017
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)×2DR REDDYSANDA 208657ABMay 15, 2017
DOXORUBICIN HYDROCHLORIDE×2AMNEALANDA 208888APFeb 17, 2017
DOXORUBICIN HYDROCHLORIDE×2ACTAVIS INCANDA 203622APJun 27, 2014
DOXORUBICIN HYDROCHLORIDESAGENT PHARMSANDA 091495APMar 18, 2013
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)×2SUN PHARMANDA 203263ABFeb 04, 2013
DOXORUBICIN HYDROCHLORIDEALMAJECTANDA 065515—Nov 08, 2012
DOXORUBICIN HYDROCHLORIDEHLTHCAREANDA 200146—Jul 18, 2012
DOXORUBICIN HYDROCHLORIDESUN PHARM INDSANDA 091418APFeb 15, 2012
DOXORUBICIN HYDROCHLORIDEPHARMOBEDIENTANDA 200901—Feb 14, 2012
DOXORUBICIN HYDROCHLORIDE×2MYLAN LABS LTDANDA 200170—Oct 28, 2011
DOXORUBICIN HYDROCHLORIDEFRESENIUS KABI USAANDA 063277APOct 26, 1995
DOXORUBICIN HYDROCHLORIDE×2TEVA PHARMS USAANDA 064140—Jul 28, 1995
DOXORUBICIN HYDROCHLORIDE×2PHARMACHEMIE BVANDA 063336—Feb 28, 1995
DOXORUBICIN HYDROCHLORIDEHIKMAANDA 064097APSep 13, 1994
ADRIAMYCIN PFS×2PFIZERANDA 063165—Jan 30, 1991
DOXORUBICIN HYDROCHLORIDE×3PHARMACHEMIE BVANDA 063097—May 21, 1990
RUBEX×3BRISTOL MYERS SQUIBBANDA 062926—Apr 13, 1989
DOXORUBICIN HYDROCHLORIDEHIKMAANDA 062975APMar 17, 1989
DOXORUBICIN HYDROCHLORIDE×3HIKMAANDA 062921—Mar 17, 1989

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Doxorubicin hydrochloride — 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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