Assyro AI

FDA Orange Book · active-ingredient family

Diazepam

Diazepam is approved as 7 brand and 86 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VALTOCO · NDA 211635

7

Brand (NDA)

86

Generics (ANDA)

8

Listed patents

6

Exclusivity periods

Brand (NDA) products · capsule, extended release, concentrate, gel, injectable, solution, spray, tablet

ProductApplicantApplicationTEApproved
VALTOCORLD×3NEURELIS INCNDA 211635—Jan 10, 2020
DIASTATRLD×7BAUSCHNDA 020648ABJul 29, 1997
VALIUMRLDROCHENDA 016087—Approved Prior to Jan 1, 1982
VALIUMRLD×3WAYLIS THERAPNDA 013263ABApproved Prior to Jan 1, 1982
DIZACPHARMACIA AND UPJOHNNDA 019287—Jun 18, 1993
DIAZEPAMUS ARMYNDA 020124—Dec 05, 1990
VALRELEASEROCHENDA 018179—Approved Prior to Jan 1, 1982

Generic (ANDA) products (86)

ProductApplicantApplicationTEApproved
DIAZEPAM×3NAVINTA LLCANDA 217468ABNov 14, 2025
DIAZEPAMGALENICUM HLTHANDA 216422APMay 19, 2025
DIAZEPAMLONG GROVE PHARMSANDA 217178APDec 31, 2024
DIAZEPAM×3NUVO PHARMANDA 070464ABSep 10, 2024
DIAZEPAMDR REDDYSANDA 218422APJul 18, 2024
DIAZEPAMALEMBICANDA 218450APApr 25, 2024
DIAZEPAM×3AUROBINDO PHARMA LTDANDA 217843ABDec 14, 2023
DIAZEPAM×2NOVEL LABS INCANDA 091076ABMay 30, 2023
DIAZEPAMFRESENIUS KABI USAANDA 214745APNov 10, 2022
DIAZEPAMREGCON HOLDINGSANDA 211998APDec 26, 2019
DIAZEPAMREGCON HOLDINGSANDA 210363APMar 18, 2019
DIAZEPAMCHARTWELL MOLECULARANDA 206477AAJun 24, 2016
DIAZEPAMCHARTWELL MOLECULARANDA 204433AAApr 14, 2014
DIAZEPAM×3STRIDES PHARMA INTLANDA 077749—Mar 31, 2006
DIAZEPAMPARENTA PHARMSANDA 076815—Apr 15, 2004
DIAZEPAMMARSAM PHARMS LLCANDA 072371—Jan 29, 1993
DIAZEPAMWATSON LABS INCANDA 072370—Jan 29, 1993
DIAZEPAMWATSON LABS INCANDA 072397—Jan 29, 1993
DIAZEPAMMARTEC USA LLCANDA 072402—Apr 25, 1989
DIAZEPAMHOSPIRAANDA 072079APDec 20, 1988
DIAZEPAMPIONEER PHARMSANDA 070787—Aug 02, 1988
DIAZEPAMPIONEER PHARMSANDA 070788—Aug 02, 1988
DIAZEPAMPIONEER PHARMSANDA 070776—Aug 02, 1988
Q-PAMQUANTUM PHARMICSANDA 072431—Apr 29, 1988
Q-PAMQUANTUM PHARMICSANDA 072432—Apr 29, 1988
Q-PAMQUANTUM PHARMICSANDA 072433—Apr 29, 1988
DIAZEPAMWARNER CHILCOTTANDA 071613—Oct 22, 1987
DIAZEPAMWARNER CHILCOTTANDA 071614—Oct 22, 1987
DIAZEPAMHOSPIRAANDA 071584—Oct 13, 1987
DIAZEPAMHOSPIRAANDA 071583APOct 13, 1987
DIAZEPAMHIKMAANDA 071308—Jul 17, 1987
DIAZEPAMHIKMAANDA 071309—Jul 17, 1987
DIAZEPAMHIKMAANDA 071310—Jul 17, 1987
DIAZEPAM INTENSOLHIKMAANDA 071415AAApr 03, 1987
DIAZEPAMHIKMAANDA 070928AAApr 03, 1987
DIAZEPAMFERNDALE LABSANDA 070903—Apr 01, 1987
DIAZEPAMFERNDALE LABSANDA 070904—Apr 01, 1987
DIAZEPAMFERNDALE LABSANDA 070905—Apr 01, 1987
DIAZEPAMDR REDDYS LABS SAANDA 071134ABFeb 03, 1987
DIAZEPAMDR REDDYS LABS SAANDA 071135ABFeb 03, 1987
DIAZEPAMDR REDDYS LABS SAANDA 071136ABFeb 03, 1987
DIAZEPAMIVAX SUB TEVA PHARMSANDA 071307ABDec 10, 1986
DIAZEPAMIVAX SUB TEVA PHARMSANDA 071321ABDec 10, 1986
DIAZEPAMIVAX SUB TEVA PHARMSANDA 071322ABDec 10, 1986
DIAZEPAMWATSON LABSANDA 070930—Dec 01, 1986
DIAZEPAMWATSON LABSANDA 070911—Aug 28, 1986
DIAZEPAMWATSON LABSANDA 070912—Aug 28, 1986
DIAZEPAMDURAMED PHARMS BARRANDA 070894—Aug 27, 1986
DIAZEPAMDURAMED PHARMS BARRANDA 070895—Aug 27, 1986
DIAZEPAMDURAMED PHARMS BARRANDA 070896—Aug 27, 1986
DIAZEPAMHALSEYANDA 070987—Aug 15, 1986
DIAZEPAMHALSEYANDA 070996—Aug 15, 1986
DIAZEPAMHALSEYANDA 070956—Aug 15, 1986
DIAZEPAMABRAXIS PHARMANDA 070662—Jun 25, 1986
DIAZEPAMROXANEANDA 070356—Jun 17, 1986
DIAZEPAMROXANEANDA 070357—Jun 17, 1986
DIAZEPAMROXANEANDA 070358—Jun 17, 1986
DIAZEPAMACTAVIS ELIZABETHANDA 070781—Mar 19, 1986
DIAZEPAMACTAVIS ELIZABETHANDA 070706—Mar 19, 1986
DIAZEPAMACTAVIS ELIZABETHANDA 070707—Mar 19, 1986
DIAZEPAMVIRTUSANDA 070462—Feb 25, 1986
DIAZEPAMVIRTUSANDA 070463—Feb 25, 1986
DIAZEPAMWATSON LABSANDA 070296—Feb 12, 1986
DIAZEPAMCHARTWELL RXANDA 070302—Dec 20, 1985
DIAZEPAMCHARTWELL RXANDA 070303—Dec 20, 1985
DIAZEPAMCHARTWELL RXANDA 070304—Dec 20, 1985
DIAZEPAM×3HIKMAANDA 070311—Dec 16, 1985
DIAZEPAMHIKMAANDA 070312—Dec 16, 1985
DIAZEPAMHIKMAANDA 070313APDec 16, 1985
Q-PAMQUANTUM PHARMICSANDA 070423—Dec 12, 1985
Q-PAMQUANTUM PHARMICSANDA 070424—Dec 12, 1985
Q-PAMQUANTUM PHARMICSANDA 070425—Dec 12, 1985
DIAZEPAMBARRANDA 070152—Nov 01, 1985
DIAZEPAMBARRANDA 070154—Nov 01, 1985
DIAZEPAMTEVA PHARMSANDA 070153—Nov 01, 1985
DIAZEPAMWATSON LABSANDA 070456—Nov 01, 1985
DIAZEPAMWATSON LABSANDA 070457—Nov 01, 1985
DIAZEPAMWATSON LABSANDA 070458—Nov 01, 1985
DIAZEPAM×3PH HEALTHANDA 070228—Sep 26, 1985
DIAZEPAMIVAX SUB TEVA PHARMSANDA 070360—Sep 04, 1985
DIAZEPAMIVAX SUB TEVA PHARMSANDA 070361—Sep 04, 1985
DIAZEPAMIVAX SUB TEVA PHARMSANDA 070362—Sep 04, 1985
DIAZEPAM×3MYLANANDA 070325ABSep 04, 1985
DIAZEPAMWARNER CHILCOTTANDA 070209—Sep 04, 1985
DIAZEPAMWARNER CHILCOTTANDA 070210—Sep 04, 1985
DIAZEPAMWARNER CHILCOTTANDA 070222—Sep 04, 1985

Marketing exclusivity (6)

  • NPPNew patient population exclusivity (3 years)

    Apr 15, 2028

    in 1 yr 10 mo

  • ODE-279Orphan-drug exclusivity (7 years)

    Jan 10, 2027

    in 7 mo

  • NPPNew patient population exclusivity (3 years)

    Apr 15, 2028

    in 1 yr 10 mo

  • ODE-279Orphan-drug exclusivity (7 years)

    Jan 10, 2027

    in 7 mo

  • NPPNew patient population exclusivity (3 years)

    Apr 15, 2028

    in 1 yr 10 mo

  • ODE-279Orphan-drug exclusivity (7 years)

    Jan 10, 2027

    in 7 mo

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12521400Mar 27, 2029in 2 yr 10 mo
Product
11793786Mar 27, 2029in 2 yr 10 mo
Product
12268664Mar 27, 2029in 2 yr 10 mo
Product
8895546Mar 27, 2029in 2 yr 10 mo
Product
11241414Mar 27, 2029in 2 yr 10 mo
Product
12337061Jun 13, 2032in 6 yr 1 mo
U-4173
12324852Oct 16, 2032in 6 yr 5 mo
U-4173
12599611Jun 10, 2042in 16 yr 3 mo
U-4455

Diazepam — 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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