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cannabidiol · Jazz Pharms Res · NDA 210365

Epidiolex

Earliest generic entry, as listed
24 Sep 2042

Blocked by patent: US 12661365. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 33 unexpired

60 Orange Book listing rows for 33 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 12661365use U-4573, U-4574, U-457524 Sep 2042
US 12661365 listing rowuse U-4573 · sets the listed date24 Sep 2042
US 12661365 listing rowuse U-4574 · sets the listed date24 Sep 2042
US 12661365 listing rowuse U-4575 · sets the listed date24 Sep 2042
US 11160795use U-32331 Mar 2041
US 11406623use U-32331 Mar 2041
US 12102619use U-32331 Mar 2041
US 11207292drug substance, use U-3235, U-3236, U-327726 Apr 2039
US 11207292 listing rowdrug substance, use U-323526 Apr 2039
US 11207292 listing rowdrug substance, use U-323626 Apr 2039
US 11207292 listing rowdrug substance, use U-327726 Apr 2039
US 11865102drug substance, drug product, use U-2781, U-3236, U-327726 Apr 2039
US 11865102 listing rowdrug substance, drug product, use U-278126 Apr 2039
US 11865102 listing rowdrug substance, drug product, use U-323626 Apr 2039
US 11865102 listing rowdrug substance, drug product, use U-327726 Apr 2039
US 10918608use U-3071, U-3072, U-307313 Oct 2035
US 10918608 listing rowuse U-307113 Oct 2035
US 10918608 listing rowuse U-307213 Oct 2035
US 10918608 listing rowuse U-307313 Oct 2035
US 11065209use U-307113 Oct 2035
US 11096905drug substance, drug product, use U-2780, U-278113 Oct 2035
US 11096905 listing rowdrug substance, drug product, use U-278013 Oct 2035
US 11096905 listing rowdrug substance, drug product, use U-278113 Oct 2035
US 11400055use U-307113 Oct 2035
US 10092525use U-242717 Jun 2035
US 10111840use U-2442, U-244317 Jun 2035
US 10111840 listing rowuse U-244217 Jun 2035
US 10111840 listing rowuse U-244317 Jun 2035
US 10137095use U-2454, U-245517 Jun 2035
US 10137095 listing rowuse U-245417 Jun 2035
US 10137095 listing rowuse U-245517 Jun 2035
US 10603288use U-2780, U-2781, U-2782, U-278317 Jun 2035
US 10603288 listing rowuse U-278017 Jun 2035
US 10603288 listing rowuse U-278117 Jun 2035
US 10603288 listing rowuse U-278217 Jun 2035
US 10603288 listing rowuse U-278317 Jun 2035
US 10709671use U-286217 Jun 2035
US 10709673drug product17 Jun 2035
US 10709674use U-2780, U-278117 Jun 2035
US 10709674 listing rowuse U-278017 Jun 2035
US 10709674 listing rowuse U-278117 Jun 2035
US 10849860use U-2427, U-245417 Jun 2035
US 10849860 listing rowuse U-242717 Jun 2035
US 10849860 listing rowuse U-245417 Jun 2035
US 10966939drug product, use U-2780, U-278117 Jun 2035
US 10966939 listing rowdrug product, use U-278017 Jun 2035
US 10966939 listing rowdrug product, use U-278117 Jun 2035
US 11154516use U-3235, U-323617 Jun 2035
US 11154516 listing rowuse U-323517 Jun 2035
US 11154516 listing rowuse U-323617 Jun 2035
US 11311498use U-3375, U-337617 Jun 2035
US 11311498 listing rowuse U-337517 Jun 2035
US 11311498 listing rowuse U-337617 Jun 2035
US 11357741use U-286217 Jun 2035
US 11446258use U-2780, U-2781, U-307117 Jun 2035
US 11446258 listing rowuse U-278017 Jun 2035
US 11446258 listing rowuse U-278117 Jun 2035
US 11446258 listing rowuse U-307117 Jun 2035
US 11633369drug product, use U-2780, U-2781, U-307117 Jun 2035
US 11633369 listing rowdrug product, use U-278017 Jun 2035
US 11633369 listing rowdrug product, use U-278117 Jun 2035
US 11633369 listing rowdrug product, use U-307117 Jun 2035
US 11701330use U-2780, U-278117 Jun 2035
US 11701330 listing rowuse U-278017 Jun 2035
US 11701330 listing rowuse U-278117 Jun 2035
US 11766411use U-278117 Jun 2035
US 11963937use U-2780, U-278117 Jun 2035
US 11963937 listing rowuse U-278017 Jun 2035
US 11963937 listing rowuse U-278117 Jun 2035
US 12064399use U-3988, U-398917 Jun 2035
US 12064399 listing rowuse U-398817 Jun 2035
US 12064399 listing rowuse U-398917 Jun 2035
US 9949937use U-242117 Jun 2035
US 9956183use U-2422, U-242317 Jun 2035
US 9956183 listing rowuse U-242217 Jun 2035
US 9956183 listing rowuse U-242317 Jun 2035
US 9956184use U-242417 Jun 2035
US 9956185use U-242517 Jun 2035
US 9956186use U-242617 Jun 2035

Exclusivities · 2 unexpired

ODE-326orphan drug (7 years)31 Jul 2027
ODE-332orphan drug (7 years)31 Jul 2027

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
210365 · 001 · RLDsolution, oral100MG/ML24 Sep 2042
Expired or delisted (1)
  • M-270 · 20 Oct 2026