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FDA Orange Book · active-ingredient family

Cannabidiol

Cannabidiol is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:EPIDIOLEX · NDA 210365

1

Brand (NDA)

0

Generics (ANDA)

32

Listed patents

3

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
EPIDIOLEXRLDJAZZ PHARMS RESNDA 210365—Sep 28, 2018

Marketing exclusivity (3)

  • M-270New use / labeling-change exclusivity (3 years)

    Oct 20, 2026

    in 4 mo

  • ODE-326Orphan-drug exclusivity (7 years)

    Jul 31, 2027

    in 1 yr 2 mo

  • ODE-332Orphan-drug exclusivity (7 years)

    Jul 31, 2027

    in 1 yr 2 mo

Listed patents (32)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9956186Jun 17, 2035in 9 yr 2 mo
U-2426
10092525Jun 17, 2035in 9 yr 2 mo
U-2427
9956183Jun 17, 2035in 9 yr 2 mo
U-2422
9949937Jun 17, 2035in 9 yr 2 mo
U-2421
10111840Jun 17, 2035in 9 yr 2 mo
U-2443
10137095Jun 17, 2035in 9 yr 2 mo
U-2454
11633369Jun 17, 2035in 9 yr 2 mo
ProductU-2780
10603288Jun 17, 2035in 9 yr 2 mo
U-2780
11357741Jun 17, 2035in 9 yr 2 mo
U-2862
10709671Jun 17, 2035in 9 yr 2 mo
U-2862
10709674Jun 17, 2035in 9 yr 2 mo
U-2781
9956184Jun 17, 2035in 9 yr 2 mo
U-2424
11963937Jun 17, 2035in 9 yr 2 mo
U-2780
9956185Jun 17, 2035in 9 yr 2 mo
U-2425
12064399Jun 17, 2035in 9 yr 2 mo
U-3988
11766411Jun 17, 2035in 9 yr 2 mo
U-2781
11154516Jun 17, 2035in 9 yr 2 mo
U-3235
10849860Jun 17, 2035in 9 yr 2 mo
U-2427
11311498Jun 17, 2035in 9 yr 2 mo
U-3375
10966939Jun 17, 2035in 9 yr 2 mo
ProductU-2780
11446258Jun 17, 2035in 9 yr 2 mo
U-2780
11701330Jun 17, 2035in 9 yr 2 mo
U-2780
10709673Jun 17, 2035in 9 yr 2 mo
Product
11065209Oct 13, 2035in 9 yr 5 mo
U-3071
10918608Oct 13, 2035in 9 yr 5 mo
U-3072
11400055Oct 13, 2035in 9 yr 5 mo
U-3071
11096905Oct 13, 2035in 9 yr 5 mo
SubstanceProductU-2780
11207292Apr 26, 2039in 13 yr
SubstanceU-3235
11865102Apr 26, 2039in 13 yr
SubstanceProductU-2781
12102619Mar 01, 2041in 14 yr 11 mo
U-3233
11160795Mar 01, 2041in 14 yr 11 mo
U-3233
11406623Mar 01, 2041in 14 yr 11 mo
U-3233

Cannabidiol — 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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