FDA Orange Book
Is there a generic for Epidiolex?
Epidiolex contains cannabidiol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Epidiolex (cannabidiol). The Orange Book shows its last listed patent expires September 24, 2042 and its last listed exclusivity ends July 31, 2027.
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Epidiolex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 100MG/ML | Marketed (Rx) | None | 0 | None |
NDA 210365, held by JAZZ PHARMACEUTICALS RESEARCH UK LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Epidiolex patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9956186 | June 17, 2035 | Method of use | U-2426 | 210365 |
| 10092525 | June 17, 2035 | Method of use | U-2427 | 210365 |
| 9956183 | June 17, 2035 | Method of use | U-2422 | 210365 |
| 9949937 | June 17, 2035 | Method of use | U-2421 | 210365 |
| 10111840 | June 17, 2035 | Method of use | U-2443 | 210365 |
| 10137095 | June 17, 2035 | Method of use | U-2454 | 210365 |
| 10111840 | June 17, 2035 | Method of use | U-2442 | 210365 |
| 11633369 | June 17, 2035 | Drug product | U-2780 | 210365 |
| 11633369 | June 17, 2035 | Drug product | U-3071 | 210365 |
| 11633369 | June 17, 2035 | Drug product | U-2781 | 210365 |
| 10603288 | June 17, 2035 | Method of use | U-2780 | 210365 |
| 10603288 | June 17, 2035 | Method of use | U-2781 | 210365 |
| 10603288 | June 17, 2035 | Method of use | U-2782 | 210365 |
| 10603288 | June 17, 2035 | Method of use | U-2783 | 210365 |
| 11357741 | June 17, 2035 | Method of use | U-2862 | 210365 |
| 10709671 | June 17, 2035 | Method of use | U-2862 | 210365 |
| 10709674 | June 17, 2035 | Method of use | U-2781 | 210365 |
| 10709674 | June 17, 2035 | Method of use | U-2780 | 210365 |
| 9956183 | June 17, 2035 | Method of use | U-2423 | 210365 |
| 9956184 | June 17, 2035 | Method of use | U-2424 | 210365 |
| 11963937 | June 17, 2035 | Method of use | U-2780 | 210365 |
| 11963937 | June 17, 2035 | Method of use | U-2781 | 210365 |
| 9956185 | June 17, 2035 | Method of use | U-2425 | 210365 |
| 12064399 | June 17, 2035 | Method of use | U-3988 | 210365 |
| 12064399 | June 17, 2035 | Method of use | U-3989 | 210365 |
| 10137095 | June 17, 2035 | Method of use | U-2455 | 210365 |
| 11766411 | June 17, 2035 | Method of use | U-2781 | 210365 |
| 11154516 | June 17, 2035 | Method of use | U-3235 | 210365 |
| 11154516 | June 17, 2035 | Method of use | U-3236 | 210365 |
| 10849860 | June 17, 2035 | Method of use | U-2427 | 210365 |
| 10849860 | June 17, 2035 | Method of use | U-2454 | 210365 |
| 11311498 | June 17, 2035 | Method of use | U-3375 | 210365 |
| 11311498 | June 17, 2035 | Method of use | U-3376 | 210365 |
| 10966939 | June 17, 2035 | Drug product | U-2780 | 210365 |
| 10966939 | June 17, 2035 | Drug product | U-2781 | 210365 |
| 11446258 | June 17, 2035 | Method of use | U-2780 | 210365 |
| 11446258 | June 17, 2035 | Method of use | U-2781 | 210365 |
| 11446258 | June 17, 2035 | Method of use | U-3071 | 210365 |
| 11701330 | June 17, 2035 | Method of use | U-2780 | 210365 |
| 11701330 | June 17, 2035 | Method of use | U-2781 | 210365 |
| 10709673 | June 17, 2035 | Drug product | None | 210365 |
| 11065209 | October 13, 2035 | Method of use | U-3071 | 210365 |
| 10918608 | October 13, 2035 | Method of use | U-3072 | 210365 |
| 10918608 | October 13, 2035 | Method of use | U-3071 | 210365 |
| 10918608 | October 13, 2035 | Method of use | U-3073 | 210365 |
| 11400055 | October 13, 2035 | Method of use | U-3071 | 210365 |
| 11096905 | October 13, 2035 | Drug substance, Drug product | U-2780 | 210365 |
| 11096905 | October 13, 2035 | Drug substance, Drug product | U-2781 | 210365 |
| 11207292 | April 26, 2039 | Drug substance | U-3235 | 210365 |
| 11207292 | April 26, 2039 | Drug substance | U-3277 | 210365 |
| 11207292 | April 26, 2039 | Drug substance | U-3236 | 210365 |
| 11865102 | April 26, 2039 | Drug substance, Drug product | U-2781 | 210365 |
| 11865102 | April 26, 2039 | Drug substance, Drug product | U-3236 | 210365 |
| 11865102 | April 26, 2039 | Drug substance, Drug product | U-3277 | 210365 |
| 12102619 | March 1, 2041 | Method of use | U-3233 | 210365 |
| 11160795 | March 1, 2041 | Method of use | U-3233 | 210365 |
| 11406623 | March 1, 2041 | Method of use | U-3233 | 210365 |
| 12661365 | September 24, 2042 | Method of use | U-4573 | 210365 |
| 12661365 | September 24, 2042 | Method of use | U-4574 | 210365 |
| 12661365 | September 24, 2042 | Method of use | U-4575 | 210365 |
Epidiolex exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-270 | Miscellaneous | October 20, 2026 | 210365 |
| ODE-326 | Orphan drug exclusivity | July 31, 2027 | 210365 |
| ODE-332 | Orphan drug exclusivity | July 31, 2027 | 210365 |
Epidiolex NDC codes
Questions
Is there a generic for Epidiolex?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Epidiolex (cannabidiol). The Orange Book shows its last listed patent expires September 24, 2042 and its last listed exclusivity ends July 31, 2027.
What is the generic name for Epidiolex?
The active ingredient in Epidiolex is cannabidiol, per the FDA Orange Book.
When does the Epidiolex patent expire?
The last patent listed for Epidiolex in the Orange Book expires September 24, 2042. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.