Assyro AI

FDA Orange Book · active-ingredient family

Carbidopa; levodopa

Carbidopa; levodopa is approved as 6 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CREXONT · NDA 217186

6

Brand (NDA)

31

Generics (ANDA)

40

Listed patents

4

Exclusivity periods

Brand (NDA) products · capsule, extended release, suspension, tablet, tablet, extended release, tablet, for suspension, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
CREXONTRLD×4IMPAXNDA 217186—Aug 07, 2024
DHIVYRLDAVION PHARMSNDA 214869—Nov 12, 2021
DUOPARLDABBVIENDA 203952—Jan 09, 2015
RYTARYRLD×4IMPAXNDA 203312—Jan 07, 2015
SINEMET CRRLD×2ORGANON LLCNDA 019856—Dec 24, 1992
SINEMETRLD×3ORGANONNDA 017555ABApproved Prior to Jan 1, 1982

Generic (ANDA) products (31)

ProductApplicantApplicationTEApproved
CARBIDOPA AND LEVODOPA×3ASCENT PHARMS INCANDA 218939ABJan 14, 2025
CARBIDOPA AND LEVODOPA×2RUBICON RESEARCHANDA 217482ABJun 04, 2024
CARBIDOPA AND LEVODOPA×3ZYDUS PHARMSANDA 215999—Apr 04, 2023
CARBIDOPA AND LEVODOPA×3AUROBINDO PHARMA LTDANDA 216537ABNov 28, 2022
CARBIDOPA AND LEVODOPA×3RUBICON RESEARCHANDA 216505ABSep 21, 2022
CARBIDOPA AND LEVODOPA×2SCIEGEN PHARMSANDA 214091ABOct 05, 2021
CARBIDOPA AND LEVODOPA×3SCIEGEN PHARMSANDA 214092ABMay 07, 2021
CARBIDOPA AND LEVODOPA×2ALEMBICANDA 210341ABJun 05, 2019
CARBIDOPA AND LEVODOPA×2ACCORD HLTHCAREANDA 202323ABFeb 08, 2013
CARBIDOPA AND LEVODOPA×3IMPAX LABSANDA 090631—Jun 08, 2010
CARBIDOPA AND LEVODOPA×3PHARMOBEDIENTANDA 090324—Sep 28, 2009
CARBIDOPA AND LEVODOPA×3SUN PHARMANDA 078690ABJul 31, 2009
CARBIDOPA AND LEVODOPA×3SUN PHARM INDSANDA 078536ABOct 28, 2008
CARBIDOPA AND LEVODOPA×3RISINGANDA 078893ABSep 18, 2008
CARBIDOPA AND LEVODOPA×3APOTEX INCANDA 077120—Jun 02, 2008
CARBIDOPA AND LEVODOPA×2SUN PHARM INDSANDA 077828—Aug 23, 2007
CARBILEV×3RANBAXYANDA 076643—Jun 10, 2005
PARCOPA×3UCB INCANDA 076699—Aug 27, 2004
CARBIDOPA AND LEVODOPAKV PHARMANDA 076663—Jun 24, 2004
CARBIDOPA AND LEVODOPA×2APOTEXANDA 076212—Jun 16, 2004
CARBIDOPA AND LEVODOPA×2IMPAX LABSANDA 076521ABMay 14, 2004
CARBIDOPA AND LEVODOPA×2MYLANANDA 075091ABApr 21, 2000
CARBIDOPA AND LEVODOPA×3ANI PHARMSANDA 073587—Jun 29, 1995
CARBIDOPA AND LEVODOPA×3SCSANDA 074080—Mar 25, 1994
CARBIDOPA AND LEVODOPAWATSON LABSANDA 073381—Sep 28, 1993
CARBIDOPA AND LEVODOPAWATSON LABSANDA 073382—Sep 28, 1993
CARBIDOPA AND LEVODOPAWATSON LABSANDA 073383—Sep 28, 1993
CARBIDOPA AND LEVODOPA×3ACTAVIS ELIZABETHANDA 074260ABSep 03, 1993
CARBIDOPA AND LEVODOPADR REDDYS LABS SAANDA 073618ABAug 28, 1992
CARBIDOPA AND LEVODOPADR REDDYS LABS SAANDA 073589ABAug 28, 1992
CARBIDOPA AND LEVODOPADR REDDYS LABS SAANDA 073607ABAug 28, 1992

Marketing exclusivity (4)

  • NPNew product exclusivity (3 years)

    Aug 07, 2027

    in 1 yr 2 mo

  • NPNew product exclusivity (3 years)

    Aug 07, 2027

    in 1 yr 2 mo

  • NPNew product exclusivity (3 years)

    Aug 07, 2027

    in 1 yr 2 mo

  • NPNew product exclusivity (3 years)

    Aug 07, 2027

    in 1 yr 2 mo

Listed patents (40)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9089607Dec 26, 2028in 2 yr 7 mo
ProductU-1645
8377474Dec 26, 2028in 2 yr 7 mo
ProductU-219
8454998Dec 26, 2028in 2 yr 7 mo
ProductU-1645
8557283Dec 26, 2028in 2 yr 7 mo
ProductU-219
9901640Dec 26, 2028in 2 yr 7 mo
ProductU-219
9533046Dec 26, 2028in 2 yr 7 mo
ProductU-219
9463246Dec 26, 2028in 2 yr 7 mo
ProductU-219
9089608Dec 26, 2028in 2 yr 7 mo
Product
11666538Oct 07, 2034in 8 yr 5 mo
ProductU-219
10987313Oct 07, 2034in 8 yr 5 mo
ProductU-219
10973769Oct 07, 2034in 8 yr 5 mo
ProductU-219
10688058Oct 07, 2034in 8 yr 5 mo
ProductU-219
10292935Oct 07, 2034in 8 yr 5 mo
ProductU-219
10098845Oct 07, 2034in 8 yr 5 mo
ProductU-219
12178919Oct 07, 2034in 8 yr 5 mo
ProductU-219
12128141Oct 07, 2034in 8 yr 5 mo
ProductU-219
12274793Oct 07, 2034in 8 yr 5 mo
Product
12303605Oct 07, 2034in 8 yr 5 mo
Product
12403099Oct 07, 2034in 8 yr 5 mo
Product
12491164Oct 07, 2034in 8 yr 5 mo
Product
11622941Oct 07, 2034in 8 yr 5 mo
Product
12178918Oct 07, 2034in 8 yr 5 mo
Product
12064521Oct 07, 2034in 8 yr 5 mo
Product
11357733Oct 07, 2034in 8 yr 5 mo
Product
11819485Mar 28, 2039in 13 yr
U-3557
11439613Mar 28, 2039in 13 yr
U-3557
11033521Mar 28, 2039in 13 yr
ProductU-219
12303482Dec 21, 2041in 15 yr 9 mo
U-1649
12295931Dec 21, 2041in 15 yr 9 mo
U-1649
12303481Dec 21, 2041in 15 yr 9 mo
U-1649
11986449Dec 21, 2041in 15 yr 9 mo
U-219
12201596Dec 21, 2041in 15 yr 9 mo
U-1649
12109185Dec 21, 2041in 15 yr 9 mo
U-1649
12458616Dec 21, 2041in 15 yr 9 mo
U-1649
12453710Dec 21, 2041in 15 yr 9 mo
U-4005
12263148Dec 21, 2041in 15 yr 9 mo
U-1649
12263149Dec 21, 2041in 15 yr 9 mo
U-1649
12447139Dec 21, 2041in 15 yr 9 mo
U-1649
12194150Dec 21, 2041in 15 yr 9 mo
U-219
12370163Dec 21, 2041in 15 yr 9 mo
U-1649

Carbidopa; levodopa — 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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