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FDA Orange Book · active-ingredient family

Naloxone hydrochloride

Naloxone hydrochloride is approved as 10 brand and 76 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:KLOXXADO · NDA 212045

10

Brand (NDA)

76

Generics (ANDA)

37

Listed patents

2

Exclusivity periods

Brand (NDA) products · injectable, solution, spray, spray, metered

ProductApplicantApplicationTEApproved
KLOXXADORLD×2HIKMANDA 212045—Aug 25, 2025
REZENOPYRLDSCIENTURENDA 215487—Apr 19, 2024
RIVIVERLDHARM REDUCTION THERPNDA 217722—Jul 28, 2023
REXTOVYRLDAMPHASTAR PHARMS INCNDA 208969—Mar 07, 2023
NALOXONE HYDROCHLORIDE (AUTOINJECTOR)RLDKALEO INCNDA 215457—Feb 28, 2022
ZIMHIRLDZMI PHARMANDA 212854—Oct 15, 2021
NARCANRLD×2EMERGENTNDA 208411—Jan 24, 2017
EVZIO (AUTOINJECTOR)RLDKALEO INCNDA 209862—Oct 19, 2016
EVZIORLDKALEO INCNDA 205787—Apr 03, 2014
NARCANRLD×3ADAPTNDA 016636—Approved Prior to Jan 1, 1982

Generic (ANDA) products (76)

ProductApplicantApplicationTEApproved
NALOXONE HYDROCHLORIDESTERINOVA INCANDA 214211APAug 21, 2025
NALOXONE HYDROCHLORIDEPADAGIS ISRAELANDA 216719—Apr 24, 2025
NALOXONE HYDROCHLORIDEAMNEALANDA 217992—Apr 23, 2024
NALOXONE HYDROCHLORIDE×2FRESENIUS KABI USAANDA 213573APApr 02, 2024
NALOXONE HYDROCHLORIDE×2HIKMAANDA 212300APMar 07, 2024
NALOXONE HYDROCHLORIDEMANKIND PHARMAANDA 218404APFeb 29, 2024
NALOXONE HYDROCHLORIDEBPI LABSANDA 216977APOct 06, 2023
NALOXONE HYDROCHLORIDEBAXTER HLTHCARE CORPANDA 214792APNov 07, 2022
NALOXONE HYDROCHLORIDE×2ACCORD HLTHCAREANDA 216624APOct 26, 2022
NALOXONE HYDROCHLORIDEPH HEALTHANDA 215964APJul 29, 2022
NALOXONE HYDROCHLORIDEPADAGIS ISRAELANDA 211951—Jun 21, 2022
NALOXONE HYDROCHLORIDEMYLAN LABS LTDANDA 213843APJun 09, 2022
NALOXONE HYDROCHLORIDE×2BAXTER HLTHCARE CORPANDA 214785APJan 29, 2021
NALOXONE HYDROCHLORIDEEUGIA PHARMAANDA 213279APJan 14, 2021
NALOXONE HYDROCHLORIDEDR REDDYSANDA 213209APMar 16, 2020
NALOXONE HYDROCHLORIDEPH HEALTHANDA 211286—Jan 17, 2020
NALOXONE HYDROCHLORIDEEUGIA PHARMAANDA 212456APNov 04, 2019
NALOXONE HYDROCHLORIDEEUGIA PHARMAANDA 212455—Oct 15, 2019
NALOXONE HYDROCHLORIDETEVA PHARMS USAANDA 209522—Apr 19, 2019
NALOXONE HYDROCHLORIDECHARTWELL RXANDA 207846—Dec 17, 2018
NALOXONE HYDROCHLORIDESOMERSET THERAPS LLCANDA 207633APAug 08, 2017
NALOXONE HYDROCHLORIDESOMERSET THERAPS LLCANDA 207634APJul 26, 2017
NALOXONE HYDROCHLORIDERISINGANDA 208872APMar 14, 2017
NALOXONE HYDROCHLORIDERISINGANDA 208871APFeb 28, 2017
NALOXONE HYDROCHLORIDEMYLAN INSTITUTIONALANDA 205014APJun 29, 2016
NALOXONE HYDROCHLORIDEMYLAN INSTITUTIONALANDA 204997APMar 06, 2014
NALOXONE HYDROCHLORIDEASTRAZENECAANDA 072081—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072082—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072083—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072084—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072085—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072086—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072087—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072088—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072089—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072090—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072091—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072092—Apr 11, 1989
NALOXONE HYDROCHLORIDEIGI LABS INCANDA 072093—Apr 11, 1989
NALOXONE HYDROCHLORIDEABRAXIS PHARMANDA 071604—Dec 16, 1988
NARCANBRISTOL MYERS SQUIBBANDA 071083—Jul 28, 1988
NARCANBRISTOL MYERS SQUIBBANDA 071084—Jul 28, 1988
NARCANBRISTOL MYERS SQUIBBANDA 071311—Jul 28, 1988
NALOXONE HYDROCHLORIDEMARSAM PHARMS LLCANDA 071811—Jul 19, 1988
NALOXONE HYDROCHLORIDEHIKMAANDA 071272—May 24, 1988
NALOXONE HYDROCHLORIDEHIKMAANDA 071273—May 24, 1988
NALOXONE HYDROCHLORIDEHIKMAANDA 071274—May 24, 1988
NALOXONE HYDROCHLORIDEHIKMAANDA 071287—May 24, 1988
NALOXONE HYDROCHLORIDEINTL MEDICATIONANDA 072115—Apr 27, 1988
NALOXONE HYDROCHLORIDEINTL MEDICATIONANDA 072076APMar 24, 1988
NALOXONE HYDROCHLORIDEWATSON LABSANDA 071339—Nov 18, 1987
NALOXONE HYDROCHLORIDESMITH AND NEPHEWANDA 071671—Nov 17, 1987
NALOXONE HYDROCHLORIDESMITH AND NEPHEWANDA 071681—Nov 17, 1987
NALOXONE HYDROCHLORIDESMITH AND NEPHEWANDA 071682—Nov 17, 1987
NALOXONE HYDROCHLORIDESOLOPAKANDA 071672—Nov 17, 1987
NALOXONE HYDROCHLORIDESOLOPAKANDA 071683—Nov 17, 1987
NALOXONE HYDROCHLORIDEHOSPIRAANDA 070252—Jan 16, 1987
NALOXONE HYDROCHLORIDEHOSPIRAANDA 070253—Jan 16, 1987
NALOXONE HYDROCHLORIDEHOSPIRAANDA 070254—Jan 07, 1987
NALOXONE HYDROCHLORIDEHOSPIRAANDA 070255—Jan 07, 1987
NALOXONE HYDROCHLORIDEHOSPIRAANDA 070256APJan 07, 1987
NALOXONE HYDROCHLORIDEHOSPIRAANDA 070257APJan 07, 1987
NALOXONE HYDROCHLORIDEABRAXIS PHARMANDA 070648—Nov 17, 1986
NALOXONE HYDROCHLORIDEABRAXIS PHARMANDA 070661—Nov 17, 1986
NALOXONE HYDROCHLORIDEABRAXIS PHARMANDA 070649—Nov 17, 1986
NALOXONEHIKMAANDA 070298—Sep 24, 1986
NALOXONEHIKMAANDA 070299APSep 24, 1986
NALOXONEHIKMAANDA 070496—Sep 24, 1986
NALOXONEWYETH AYERSTANDA 070188—Sep 24, 1986
NALOXONEWYETH AYERSTANDA 070189—Sep 24, 1986
NALOXONEWYETH AYERSTANDA 070190—Sep 24, 1986
NALOXONEWYETH AYERSTANDA 070191—Sep 24, 1986
NALOXONE HYDROCHLORIDEHOSPIRAANDA 070171—Sep 24, 1986
NALOXONE HYDROCHLORIDEHOSPIRAANDA 070172APSep 24, 1986
NALOXONE HYDROCHLORIDEINTL MEDICATIONANDA 070417—Sep 24, 1986
NALOXONE HYDROCHLORIDEINTL MEDICATIONANDA 070639—Sep 24, 1986

Marketing exclusivity (2)

  • NPNew product exclusivity (3 years)

    Mar 07, 2026

    3 mo ago

  • NPNew product exclusivity (3 years)

    Apr 19, 2027

    in 10 mo

Listed patents (37)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9278182Feb 01, 20265 mo ago
Product
8926594Mar 31, 20263 mo ago
Product
7731686Jun 10, 20269 d ago
Product
10960155Jun 25, 2026in 6 d
Product
11590286Dec 12, 2026in 6 mo
Product
9238108Feb 20, 2027in 8 mo
Product
8206360Feb 27, 2027in 8 mo
Product
9724471May 23, 2027in 11 mo
ProductU-2092
7947017Mar 12, 2028in 1 yr 9 mo
Product
7749194Oct 30, 2028in 2 yr 5 mo
Product
8231573Nov 25, 2028in 2 yr 6 mo
Product
8226610Apr 10, 2029in 2 yr 10 mo
Product
8021344Nov 02, 2029in 3 yr 5 mo
Product
9474869Feb 28, 2031in 4 yr 9 mo
ProductU-1907
10322239Feb 28, 2031in 4 yr 9 mo
U-1907
8939943Feb 28, 2031in 4 yr 9 mo
Product
9022022Feb 28, 2031in 4 yr 9 mo
Product
9814838Feb 28, 2031in 4 yr 9 mo
Product
10143972May 24, 2031in 5 yr
U-2476
10143792May 24, 2031in 5 yr
U-2476
8627816Feb 04, 2032in 5 yr 9 mo
Product
12458591May 11, 2032in 6 yr
U-3671
11020343May 11, 2032in 6 yr
U-3671
11806428May 11, 2032in 6 yr
Product
9517307Jul 18, 2034in 8 yr 2 mo
ProductU-1925
11617713Aug 26, 2034in 8 yr 4 mo
ProductU-3110
11628139Aug 26, 2034in 8 yr 4 mo
ProductU-3110
10973814Aug 26, 2034in 8 yr 4 mo
ProductU-3110
10722510Aug 26, 2034in 8 yr 4 mo
ProductU-3110
11975096Aug 26, 2034in 8 yr 4 mo
Product
12414915Aug 26, 2034in 8 yr 4 mo
Product
11135155Aug 26, 2034in 8 yr 4 mo
Product
10220158Mar 20, 2035in 8 yr 11 mo
ProductU-2500
11027072May 24, 2039in 13 yr 1 mo
Product
12514854Feb 05, 2041in 14 yr 10 mo
U-4397
12622903Feb 05, 2041in 14 yr 10 mo
Product
11571518Jun 14, 2041in 15 yr 2 mo
ProductU-3515

Naloxone 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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