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FDA Orange Book · active-ingredient family

Bupropion hydrochloride

Bupropion hydrochloride is approved as 5 brand and 62 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FORFIVO XL · NDA 022497

5

Brand (NDA)

62

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, tablet, extended release

ProductApplicantApplicationTEApproved
FORFIVO XLRLDTWI PHARMSNDA 022497—Nov 10, 2011
WELLBUTRIN XLRLD×2BAUSCHNDA 021515AB3Aug 28, 2003
ZYBANRLD×2GLAXOSMITHKLINENDA 020711—May 14, 1997
WELLBUTRIN SRRLD×4GLAXOSMITHKLINENDA 020358AB1Oct 04, 1996
WELLBUTRINRLD×3GLAXOSMITHKLINENDA 018644—Dec 30, 1985

Generic (ANDA) products (62)

ProductApplicantApplicationTEApproved
BUPROPION HYDROCHLORIDE×3YICHANG HUMANWELLANDA 220529AB1May 04, 2026
BUPROPION HYDROCHLORIDE×2ANNORA PHARMAANDA 217898AB3Oct 01, 2025
BUPROPION HYDROCHLORIDE×3IPCA LABS LTDANDA 207874AB1May 02, 2025
BUPROPION HYDROCHLORIDE×3GRANULESANDA 218385AB1Oct 17, 2024
BUPROPION HYDROCHLORIDE×3ANNORA PHARMAANDA 216800AB1May 31, 2023
BUPROPION HYDROCHLORIDEYICHANG HUMANWELLANDA 216766AB2Jan 09, 2023
BUPROPION HYDROCHLORIDE×2GRANULESANDA 215568AB3Feb 02, 2022
BUPROPION HYDROCHLORIDESUN PHARMANDA 203650—Dec 31, 2020
BUPROPION HYDROCHLORIDESUN PHARMANDA 200216—Nov 30, 2020
BUPROPION HYDROCHLORIDE×2ZHEJIANG JUTAI PHARMANDA 211200AB3Apr 29, 2020
BUPROPION HYDROCHLORIDE×2MICRO LABSANDA 207403ABApr 17, 2020
BUPROPION HYDROCHLORIDE×2CADILA PHARMS LTDANDA 208606ABJan 16, 2020
BUPROPION HYDROCHLORIDE×2GRAVITI PHARMSANDA 211020AB3Jan 28, 2019
BUPROPION HYDROCHLORIDE×2ACCORD HLTHCAREANDA 210497AB3Oct 31, 2018
BUPROPION HYDROCHLORIDE×3YICHANG HUMANWELLANDA 211347AB1Oct 16, 2018
BUPROPION HYDROCHLORIDE×2ZYDUS PHARMSANDA 201567AB3Jul 23, 2018
BUPROPION HYDROCHLORIDE×2YICHANG HUMANWELLANDA 210015AB3Jun 14, 2018
BUPROPION HYDROCHLORIDE×2ALEMBICANDA 203013ABJun 08, 2018
BUPROPION HYDROCHLORIDE×2TWI PHARMSANDA 210081—Nov 03, 2017
BUPROPION HYDROCHLORIDE×2INVAGEN PHARMSANDA 207389—Sep 18, 2017
BUPROPION HYDROCHLORIDE×2SINOTHERAPEUTICS INCANDA 208652AB3Aug 21, 2017
BUPROPION HYDROCHLORIDE×2ANBISON LABANDA 207224AB3Jun 30, 2017
BUPROPION HYDROCHLORIDE×2JUBILANT GENERICSANDA 207459—Jun 30, 2017
BUPROPION HYDROCHLORIDE×2SCIEGEN PHARMSANDA 207479AB3Apr 12, 2017
BUPROPION HYDROCHLORIDE×2LUPINANDA 090693AB3Apr 06, 2017
BUPROPION HYDROCHLORIDE×2INVAGEN PHARMSANDA 206556—Aug 26, 2016
BUPROPION HYDROCHLORIDE×2HERITAGE PHARMAANDA 206975ABAug 19, 2016
BUPROPION HYDROCHLORIDESCIEGEN PHARMSANDA 206122AB2Aug 17, 2016
BUPROPION HYDROCHLORIDE×3SCIEGEN PHARMSANDA 205794AB1Mar 01, 2016
BUPROPION HYDROCHLORIDE×3INVAGEN PHARMSANDA 206674—Feb 09, 2016
BUPROPION HYDROCHLORIDE×3PRINSTON INCANDA 202304AB1May 26, 2015
BUPROPION HYDROCHLORIDESUN PHARMANDA 200695—Dec 18, 2014
BUPROPION HYDROCHLORIDE×3TORRENTANDA 203969—Oct 31, 2014
BUPROPION HYDROCHLORIDE×3JUBILANT GENERICSANDA 202774—Oct 11, 2013
BUPROPION HYDROCHLORIDEJUBILANT GENERICSANDA 202775—Oct 11, 2013
BUPROPION HYDROCHLORIDE×2WOCKHARDT LTDANDA 202189AB3Nov 21, 2012
BUPROPION HYDROCHLORIDE×3WOCKHARDT LTDANDA 201331—Aug 30, 2012
BUPROPION HYDROCHLORIDE×3PH HEALTHANDA 091459—Jun 09, 2011
BUPROPION HYDROCHLORIDEPH HEALTHANDA 091520—Jun 09, 2011
BUPROPION HYDROCHLORIDE×3WATSON LABS INCANDA 077455—Jul 19, 2010
BUPROPION HYDROCHLORIDE×2AUROBINDO PHARMA USAANDA 090942—Jul 14, 2010
BUPROPION HYDROCHLORIDERISINGANDA 090941—May 03, 2010
BUPROPION HYDROCHLORIDE×3AUROBINDO PHARMA USAANDA 090325AB1Apr 08, 2010
BUPROPION HYDROCHLORIDE×3SUN PHARMANDA 078866—Apr 06, 2010
BUPROPION HYDROCHLORIDE×3ACTAVIS LABS FL INCANDA 079095AB1Mar 24, 2009
BUPROPION HYDROCHLORIDEACTAVIS LABS FL INCANDA 079094AB2Mar 24, 2009
BUPROPION HYDROCHLORIDE×2ACTAVIS LABS FL INCANDA 077715AB3Nov 26, 2008
BUPROPION HYDROCHLORIDE×2IMPAX LABSANDA 077415—Nov 26, 2008
BUPROPION HYDROCHLORIDE×2WATSON LABS INCANDA 077285AB3Nov 26, 2008
BUPROPION HYDROCHLORIDESANDOZANDA 077475AB2Mar 12, 2008
BUPROPION HYDROCHLORIDE×2PH HEALTHANDA 077284—Dec 14, 2006
BUPROPION HYDROCHLORIDE×2APOTEXANDA 076143ABJan 17, 2006
BUPROPION HYDROCHLORIDECHARTWELL RXANDA 076834—Jul 14, 2005
BUPROPION HYDROCHLORIDE×2SANDOZANDA 076845—Jul 14, 2005
BUPROPION HYDROCHLORIDEIMPAX LABSANDA 076711—Dec 03, 2004
BUPROPION HYDROCHLORIDEIMPAX LABSANDA 075914AB2May 27, 2004
BUPROPION HYDROCHLORIDE×2IMPAX LABSANDA 075913AB1Jan 28, 2004
BUPROPION HYDROCHLORIDE×3EPIC PHARMA LLCANDA 075932AB1Nov 25, 2003
BUPROPION HYDROCHLORIDE×2INVATECHANDA 075613—Oct 10, 2000
BUPROPION HYDROCHLORIDE×2AUROBINDO PHARMA USAANDA 075491ABApr 17, 2000
BUPROPION HYDROCHLORIDE×2SENORES PHARMSANDA 075584ABFeb 07, 2000
BUPROPION HYDROCHLORIDE×2HERITAGE PHARMAANDA 075310—Nov 29, 1999

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7674479Aug 23, 2028in 2 yr 3 mo
Product

Bupropion hydrochloride — frequently asked questions

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

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