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FDA Orange Book · active-ingredient family

Entecavir

Entecavir is approved as 2 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BARACLUDE · NDA 021798

2

Brand (NDA)

18

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution, tablet

ProductApplicantApplicationTEApproved
BARACLUDERLDBRISTOL MYERS SQUIBBNDA 021798—Mar 29, 2005
BARACLUDERLD×2BRISTOL MYERS SQUIBBNDA 021797ABMar 29, 2005

Generic (ANDA) products (18)

ProductApplicantApplicationTEApproved
ENTECAVIR×2CONBA USAANDA 216857ABDec 23, 2024
ENTECAVIR×2YUNG SHIN PHARMANDA 208195ABNov 10, 2021
ENTECAVIR×2PHARMADAXANDA 212106—Aug 10, 2020
ENTECAVIR×2SUNSHINEANDA 211978—May 20, 2020
ENTECAVIR×2YAOPHARMA CO LTDANDA 212201—Nov 04, 2019
ENTECAVIR×2BRIGHTGENEANDA 212126ABSep 25, 2019
ENTECAVIR×2RISINGANDA 206226—Mar 26, 2019
ENTECAVIR×2BRECKENRIDGEANDA 208721—Mar 15, 2018
ENTECAVIR×2PRINSTON INCANDA 208782—Oct 10, 2017
ENTECAVIR×2ACCORD HLTHCAREANDA 205824—Aug 25, 2017
ENTECAVIR×2ZYDUS PHARMSANDA 206745ABJun 23, 2017
ENTECAVIR×2CHARTWELL RXANDA 206672—May 11, 2017
ENTECAVIR×2CIPLAANDA 206872ABDec 06, 2016
ENTECAVIR×2CHARTWELL RXANDA 206294—Nov 23, 2016
ENTECAVIR×2AMNEAL PHARMSANDA 206652ABNov 12, 2015
ENTECAVIR×2AUROBINDO PHARMAANDA 206217ABAug 26, 2015
ENTECAVIR×2HETERO LABS LTD VANDA 205740ABAug 21, 2015
ENTECAVIR×2TEVA PHARMS USAANDA 202122—Aug 26, 2014

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.

Entecavir — frequently asked questions

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

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