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FDA Orange Book · active-ingredient family

Gemcitabine hydrochloride

Gemcitabine hydrochloride is approved as 6 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:INLEXZO · NDA 219683

6

Brand (NDA)

28

Generics (ANDA)

6

Listed patents

1

Exclusivity periods

Brand (NDA) products · injectable, solution, system

ProductApplicantApplicationTEApproved
INLEXZORLDJANSSEN BIOTECHNDA 219683—Sep 09, 2025
AVGEMSIRLD×3AVYXA HOLDINGSNDA 219920—Jun 27, 2025
INFUGEMRLD×10SUN PHARMNDA 208313—Jul 16, 2018
GEMCITABINE HYDROCHLORIDERLD×4ACCORD HLTHCARENDA 209604—Aug 03, 2017
GEMCITABINE HYDROCHLORIDERLD×3HOSPIRA INCNDA 200795APAug 04, 2011
GEMZARRLD×2LILLYNDA 020509—May 15, 1996

Generic (ANDA) products (28)

ProductApplicantApplicationTEApproved
GEMCITABINE HYDROCHLORIDE×3HIKMAANDA 213175APMar 07, 2023
GEMCITABINE HYDROCHLORIDE×2HIKMA INTL PHARMSANDA 206617—Jun 25, 2021
GEMCITABINE HYDROCHLORIDE×3MEITHEALANDA 212129APDec 11, 2020
GEMCITABINE HYDROCHLORIDE×3SHILPAANDA 210991APOct 04, 2019
GEMCITABINE HYDROCHLORIDE×2SHILPAANDA 207575APFeb 22, 2019
GEMCITABINE HYDROCHLORIDE×3INGENUS PHARMS LLCANDA 210383—Feb 14, 2019
GEMCITABINE HYDROCHLORIDE×3SAGENT PHARMS INCANDA 209077APJul 20, 2018
GEMCITABINE HYDROCHLORIDE×3MYLAN LABS LTDANDA 205242APDec 06, 2017
GEMCITABINE HYDROCHLORIDE×3APOTEXANDA 206776—May 23, 2017
GEMCITABINE HYDROCHLORIDE×3ACTAVIS INCANDA 204549—Apr 11, 2016
GEMCITABINE HYDROCHLORIDE×2GLANDANDA 204520APJan 05, 2016
GEMCITABINE HYDROCHLORIDE×2AM REGENTANDA 202031—May 07, 2013
GEMCITABINE HYDROCHLORIDEDR REDDYS LABS LTDANDA 202997APMay 07, 2013
GEMCITABINE HYDROCHLORIDE×2JIANGSU HANSOH PHARMANDA 202485APMay 07, 2013
GEMCITABINE HYDROCHLORIDE×2SAGENT PHARMSANDA 091597—May 07, 2013
GEMCITABINE HYDROCHLORIDE×2EMCURE PHARMS LTDANDA 202063—Sep 11, 2012
GEMCITABINE HYDROCHLORIDE×2HAMELN RDS GMBHANDA 090663—Sep 10, 2012
GEMCITABINE HYDROCHLORIDE×3ACCORD HLTHCAREANDA 091594—Jul 25, 2011
GEMCITABINE HYDROCHLORIDE×3ACTAVIS TOTOWAANDA 079160—Jul 25, 2011
GEMCITABINE HYDROCHLORIDE×2DR REDDYS LABS LTDANDA 091365APJul 25, 2011
GEMCITABINE HYDROCHLORIDE×3FRESENIUS KABI USAANDA 090799APJul 25, 2011
GEMCITABINE HYDROCHLORIDE×2HOSPIRAANDA 078339APJul 25, 2011
GEMCITABINE HYDROCHLORIDE×3PHARMOBEDIENTANDA 200145—Jul 25, 2011
GEMCITABINE HYDROCHLORIDE×2SUN PHARMANDA 078433APJul 25, 2011
GEMCITABINE HYDROCHLORIDE×2TEYRO LABSANDA 078759APJul 25, 2011
GEMCITABINE HYDROCHLORIDEFRESENIUS KABI USAANDA 090242APMay 16, 2011
GEMCITABINE HYDROCHLORIDE×2TEVA PHARMSANDA 077983—Jan 25, 2011
GEMCITABINE HYDROCHLORIDEHOSPIRA INCANDA 079183APNov 15, 2010

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Sep 09, 2028

    in 2 yr 3 mo

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12403086Jun 28, 2030in 4 yr 1 mo
Product
12576253Dec 17, 2030in 4 yr 7 mo
Product
8679094Apr 15, 2032in 5 yr 11 mo
Product
9241948Jul 01, 2033in 7 yr 2 mo
Product
10729823Aug 19, 2034in 8 yr 3 mo
Product
12447241Aug 19, 2034in 8 yr 3 mo
Product

Gemcitabine 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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