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FDA Orange Book · active-ingredient family

Irinotecan hydrochloride

Irinotecan hydrochloride is approved as 2 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ONIVYDE · NDA 207793

2

Brand (NDA)

26

Generics (ANDA)

14

Listed patents

2

Exclusivity periods

Brand (NDA) products · injectable, injectable, liposomal

ProductApplicantApplicationTEApproved
ONIVYDERLDIPSENNDA 207793—Oct 22, 2015
CAMPTOSARRLD×3PFIZER INCNDA 020571APJun 14, 1996

Generic (ANDA) products (26)

ProductApplicantApplicationTEApproved
IRINOTECAN HYDROCHLORIDE×4EUGIA PHARMAANDA 213278APNov 02, 2020
IRINOTECAN HYDROCHLORIDE×2GLANDANDA 212993APNov 18, 2019
IRINOTECAN HYDROCHLORIDE×3SHILPAANDA 208718APDec 28, 2018
IRINOTECAN HYDROCHLORIDE×2INTAS PHARMS USAANDA 203054APAug 31, 2017
IRINOTECAN HYDROCHLORIDE×2INGENUS PHARMS LLCANDA 206935APMay 26, 2017
IRINOTECAN HYDROCHLORIDE×3QILU PHARM HAINANANDA 203380APMay 03, 2016
IRINOTECAN HYDROCHLORIDE×2EMCURE PHARMS LTDANDA 200771—Feb 14, 2012
IRINOTECAN HYDROCHLORIDE×2HENGRUI PHARMAANDA 090675—Dec 16, 2011
IRINOTECAN HYDROCHLORIDE×2PHARMOBEDIENTANDA 090393APMay 13, 2011
IRINOTECAN HYDROCHLORIDE×2HIKMA FARMACEUTICAANDA 091032APDec 20, 2010
IRINOTECAN HYDROCHLORIDE×2CHARTWELL RXANDA 078953—Apr 15, 2010
IRINOTECAN HYDROCHLORIDE×2SANDOZANDA 090137—Nov 12, 2009
IRINOTECAN HYDROCHLORIDE×2EPIC PHARMA LLCANDA 090726APSep 16, 2009
IRINOTECAN HYDROCHLORIDE×2HISUN PHARM HANGZHOUANDA 090016—Jan 28, 2009
IRINOTECAN HYDROCHLORIDE×2HIKMAANDA 078753APDec 24, 2008
IRINOTECAN HYDROCHLORIDE×2ACCORD HLTHCAREANDA 079068APNov 21, 2008
IRINOTECAN HYDROCHLORIDE×2PLIVA LACHEMAANDA 078122—Oct 31, 2008
IRINOTECAN HYDROCHLORIDE×2SUN PHARMA GLOBALANDA 078805—Apr 21, 2008
IRINOTECAN HYDROCHLORIDE×3ACTAVIS TOTOWAANDA 078589APFeb 27, 2008
IRINOTECAN HYDROCHLORIDE×2FRESENIUS KABI USAANDA 077776APFeb 27, 2008
IRINOTECAN HYDROCHLORIDE×2FRESENIUS KABI USAANDA 078188—Feb 27, 2008
IRINOTECAN HYDROCHLORIDE×2HOSPIRAANDA 077915APFeb 27, 2008
IRINOTECAN HYDROCHLORIDEHOSPIRAANDA 078796APFeb 27, 2008
IRINOTECAN HYDROCHLORIDE×2SANDOZANDA 077994—Feb 27, 2008
IRINOTECAN HYDROCHLORIDE×3TEVA PHARMS USAANDA 090101—Feb 27, 2008
IRINOTECAN HYDROCHLORIDE×2CIPLA LTDANDA 077219—Feb 20, 2008

Marketing exclusivity (2)

  • I-932New indication exclusivity (3 years)

    Feb 13, 2027

    in 8 mo

  • ODE-463Orphan-drug exclusivity (7 years)

    Feb 13, 2031

    in 4 yr 9 mo

Listed patents (14)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8329213Jan 06, 2027in 7 mo
SubstanceProduct
8147867Aug 29, 2028in 2 yr 3 mo
SubstanceProduct
9717724Jun 12, 2033in 7 yr 1 mo
U-2091
9492442Jun 12, 2033in 7 yr 1 mo
U-1917
9364473Jun 12, 2033in 7 yr 1 mo
U-1856
12364691Jun 12, 2033in 7 yr 1 mo
U-1848
11369597Jun 12, 2033in 7 yr 1 mo
U-1848
9339497Jun 12, 2033in 7 yr 1 mo
U-1848
9452162Jun 12, 2033in 7 yr 1 mo
U-1899
10980795Jun 12, 2033in 7 yr 1 mo
U-1848
11344552Aug 19, 2036in 10 yr 4 mo
U-3824
12059497Oct 15, 2036in 10 yr 6 mo
Product
10456360Oct 15, 2036in 10 yr 6 mo
Product
10993914Oct 15, 2036in 10 yr 6 mo
Product

Irinotecan hydrochloride — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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