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Orange Book drug · Brand (NDA)

Epidiolex

Cannabidiol

RLDNDA 210365 Jazz Pharms Res
Approved
Sep 28, 2018
Strengths
1
Listed patents
32

What does the FDA Orange Book show for Epidiolex?

Epidiolex contains Cannabidiol and is the new drug FDA Orange Book record for NDA 210365. The application has 1 presentation with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 210365

New drug application identity from the Orange Book snapshot.

Application holder
Jazz Pharmaceuticals Research UK Ltd

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
32

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
3

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001100MG/MLSOLUTIONORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Jazz Pharmaceuticals Research UK Ltd

The Orange Book identifies this organization as the applicant responsible for NDA 210365.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

32 listed patent expirations and 3 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Mar 01, 2041. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 210365 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Oral

Cannabidiol

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-210365

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 210365
RLDRS
Strength
100MG/ML
Dosage form
SOLUTION
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    7 yr 11 mo ago

  2. Today

  3. Exclusivity ends · M-270

    New use / labeling-change exclusivity (3 years)

    in 3 mo

  4. Exclusivity ends · ODE-326

    Orphan-drug exclusivity (7 years)

    in 1 yr

  5. Exclusivity ends · ODE-332

    Orphan-drug exclusivity (7 years)

    in 1 yr

  6. Patent 10092525 expires

    Listed method-of-use patent (U-2427) expiration.

    in 9 yr

  7. Patent 10111840 expires

    Listed method-of-use patent (U-2443) expiration.

    in 9 yr

  8. Patent 10111840 expires

    Listed method-of-use patent (U-2442) expiration.

    in 9 yr

  9. Patent 10137095 expires

    Listed method-of-use patent (U-2454) expiration.

    in 9 yr

  10. Patent 10137095 expires

    Listed method-of-use patent (U-2455) expiration.

    in 9 yr

  11. Patent 10603288 expires

    Listed method-of-use patent (U-2780) expiration.

    in 9 yr

  12. Patent 10603288 expires

    Listed method-of-use patent (U-2781) expiration.

    in 9 yr

  13. Patent 10603288 expires

    Listed method-of-use patent (U-2782) expiration.

    in 9 yr

  14. Patent 10603288 expires

    Listed method-of-use patent (U-2783) expiration.

    in 9 yr

  15. Patent 10709671 expires

    Listed method-of-use patent (U-2862) expiration.

    in 9 yr

  16. Patent 10709673 expires

    Listed drug product patent expiration.

    in 9 yr

  17. Patent 10709674 expires

    Listed method-of-use patent (U-2781) expiration.

    in 9 yr

  18. Patent 10709674 expires

    Listed method-of-use patent (U-2780) expiration.

    in 9 yr

  19. Patent 10849860 expires

    Listed method-of-use patent (U-2427) expiration.

    in 9 yr

  20. Patent 10849860 expires

    Listed method-of-use patent (U-2454) expiration.

    in 9 yr

  21. Patent 10966939 expires

    Listed drug product patent expiration.

    in 9 yr

  22. Patent 10966939 expires

    Listed drug product patent expiration.

    in 9 yr

  23. Patent 11154516 expires

    Listed method-of-use patent (U-3235) expiration.

    in 9 yr

  24. Patent 11154516 expires

    Listed method-of-use patent (U-3236) expiration.

    in 9 yr

  25. Patent 11311498 expires

    Listed method-of-use patent (U-3375) expiration.

    in 9 yr

  26. Patent 11311498 expires

    Listed method-of-use patent (U-3376) expiration.

    in 9 yr

  27. Patent 11357741 expires

    Listed method-of-use patent (U-2862) expiration.

    in 9 yr

  28. Patent 11446258 expires

    Listed method-of-use patent (U-2780) expiration.

    in 9 yr

  29. Patent 11446258 expires

    Listed method-of-use patent (U-2781) expiration.

    in 9 yr

  30. Patent 11446258 expires

    Listed method-of-use patent (U-3071) expiration.

    in 9 yr

  31. Patent 11633369 expires

    Listed drug product patent expiration.

    in 9 yr

  32. Patent 11633369 expires

    Listed drug product patent expiration.

    in 9 yr

  33. Patent 11633369 expires

    Listed drug product patent expiration.

    in 9 yr

  34. Patent 11701330 expires

    Listed method-of-use patent (U-2780) expiration.

    in 9 yr

  35. Patent 11701330 expires

    Listed method-of-use patent (U-2781) expiration.

    in 9 yr

  36. Patent 11766411 expires

    Listed method-of-use patent (U-2781) expiration.

    in 9 yr

  37. Patent 11963937 expires

    Listed method-of-use patent (U-2780) expiration.

    in 9 yr

  38. Patent 11963937 expires

    Listed method-of-use patent (U-2781) expiration.

    in 9 yr

  39. Patent 12064399 expires

    Listed method-of-use patent (U-3988) expiration.

    in 9 yr

  40. Patent 12064399 expires

    Listed method-of-use patent (U-3989) expiration.

    in 9 yr

  41. Patent 9949937 expires

    Listed method-of-use patent (U-2421) expiration.

    in 9 yr

  42. Patent 9956183 expires

    Listed method-of-use patent (U-2422) expiration.

    in 9 yr

  43. Patent 9956183 expires

    Listed method-of-use patent (U-2423) expiration.

    in 9 yr

  44. Patent 9956184 expires

    Listed method-of-use patent (U-2424) expiration.

    in 9 yr

  45. Patent 9956185 expires

    Listed method-of-use patent (U-2425) expiration.

    in 9 yr

  46. Patent 9956186 expires

    Listed method-of-use patent (U-2426) expiration.

    in 9 yr

  47. Patent 10918608 expires

    Listed method-of-use patent (U-3072) expiration.

    in 9 yr 4 mo

  48. Patent 10918608 expires

    Listed method-of-use patent (U-3071) expiration.

    in 9 yr 4 mo

  49. Patent 10918608 expires

    Listed method-of-use patent (U-3073) expiration.

    in 9 yr 4 mo

  50. Patent 11065209 expires

    Listed method-of-use patent (U-3071) expiration.

    in 9 yr 4 mo

  51. Patent 11096905 expires

    Listed drug substance patent expiration.

    in 9 yr 4 mo

  52. Patent 11096905 expires

    Listed drug substance patent expiration.

    in 9 yr 4 mo

  53. Patent 11400055 expires

    Listed method-of-use patent (U-3071) expiration.

    in 9 yr 4 mo

  54. Patent 11207292 expires

    Listed drug substance patent expiration.

    in 12 yr 11 mo

  55. Patent 11207292 expires

    Listed drug substance patent expiration.

    in 12 yr 11 mo

  56. Patent 11207292 expires

    Listed drug substance patent expiration.

    in 12 yr 11 mo

  57. Patent 11865102 expires

    Listed drug substance patent expiration.

    in 12 yr 11 mo

  58. Patent 11865102 expires

    Listed drug substance patent expiration.

    in 12 yr 11 mo

  59. Patent 11865102 expires

    Listed drug substance patent expiration.

    in 12 yr 11 mo

  60. Patent 11160795 expires

    Listed method-of-use patent (U-3233) expiration.

    in 14 yr 10 mo

  61. Patent 11406623 expires

    Listed method-of-use patent (U-3233) expiration.

    in 14 yr 10 mo

  62. Patent 12102619 expires

    Listed method-of-use patent (U-3233) expiration.

    in 14 yr 10 mo

Patent & exclusivity timeline

Protection horizon
202620282030203220342036203820402042TodayExclusivity M-270: 2026-10-20Exclusivity M-270Exclusivity ODE-326: 2027-07-31Exclusivity ODE-326Exclusivity ODE-332: 2027-07-31Exclusivity ODE-332Patent 10092525: 2035-06-17Patent 10092525Patent 10111840: 2035-06-17Patent 10111840Patent 10111840: 2035-06-17Patent 10111840Patent 10137095: 2035-06-17Patent 10137095Patent 10137095: 2035-06-17Patent 10137095Patent 10603288: 2035-06-17Patent 10603288Patent 10603288: 2035-06-17Patent 10603288Patent 10603288: 2035-06-17Patent 10603288Patent 10603288: 2035-06-17Patent 10603288Patent 10709671: 2035-06-17Patent 10709671Patent 10709673: 2035-06-17Patent 10709673Patent 10709674: 2035-06-17Patent 10709674Patent 10709674: 2035-06-17Patent 10709674Patent 10849860: 2035-06-17Patent 10849860Patent 10849860: 2035-06-17Patent 10849860Patent 10966939: 2035-06-17Patent 10966939Patent 10966939: 2035-06-17Patent 10966939Patent 11154516: 2035-06-17Patent 11154516Patent 11154516: 2035-06-17Patent 11154516Patent 11311498: 2035-06-17Patent 11311498Patent 11311498: 2035-06-17Patent 11311498Patent 11357741: 2035-06-17Patent 11357741Patent 11446258: 2035-06-17Patent 11446258Patent 11446258: 2035-06-17Patent 11446258Patent 11446258: 2035-06-17Patent 11446258Patent 11633369: 2035-06-17Patent 11633369Patent 11633369: 2035-06-17Patent 11633369Patent 11633369: 2035-06-17Patent 11633369Patent 11701330: 2035-06-17Patent 11701330Patent 11701330: 2035-06-17Patent 11701330Patent 11766411: 2035-06-17Patent 11766411Patent 11963937: 2035-06-17Patent 11963937Patent 11963937: 2035-06-17Patent 11963937Patent 12064399: 2035-06-17Patent 12064399Patent 12064399: 2035-06-17Patent 12064399Patent 9949937: 2035-06-17Patent 9949937Patent 9956183: 2035-06-17Patent 9956183Patent 9956183: 2035-06-17Patent 9956183Patent 9956184: 2035-06-17Patent 9956184Patent 9956185: 2035-06-17Patent 9956185Patent 9956186: 2035-06-17Patent 9956186Patent 10918608: 2035-10-13Patent 10918608Patent 10918608: 2035-10-13Patent 10918608Patent 10918608: 2035-10-13Patent 10918608Patent 11065209: 2035-10-13Patent 11065209Patent 11096905: 2035-10-13Patent 11096905Patent 11096905: 2035-10-13Patent 11096905Patent 11400055: 2035-10-13Patent 11400055Patent 11207292: 2039-04-26Patent 11207292Patent 11207292: 2039-04-26Patent 11207292Patent 11207292: 2039-04-26Patent 11207292Patent 11865102: 2039-04-26Patent 11865102Patent 11865102: 2039-04-26Patent 11865102Patent 11865102: 2039-04-26Patent 11865102Patent 11160795: 2041-03-01Patent 11160795Patent 11406623: 2041-03-01Patent 11406623Patent 12102619: 2041-03-01Patent 12102619
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

CANNABIDIOL

Strength

100MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 210365

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

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

    in 3 mo

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

    in 1 yr

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

    in 1 yr

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10092525in 9 yr
U-2427
10111840in 9 yr
U-2443
10111840in 9 yr
U-2442
10137095in 9 yr
U-2454
10137095in 9 yr
U-2455
10603288in 9 yr
U-2780
10603288in 9 yr
U-2781
10603288in 9 yr
U-2782
10603288in 9 yr
U-2783
10709671in 9 yr
U-2862
10709673in 9 yr
Product
10709674in 9 yr
U-2781
10709674in 9 yr
U-2780
10849860in 9 yr
U-2427
10849860in 9 yr
U-2454
10966939in 9 yr
ProductU-2780
10966939in 9 yr
ProductU-2781
11154516in 9 yr
U-3235
11154516in 9 yr
U-3236
11311498in 9 yr
U-3375
11311498in 9 yr
U-3376
11357741in 9 yr
U-2862
11446258in 9 yr
U-2780
11446258in 9 yr
U-2781
11446258in 9 yr
U-3071
11633369in 9 yr
ProductU-2780
11633369in 9 yr
ProductU-3071
11633369in 9 yr
ProductU-2781
11701330in 9 yr
U-2780
11701330in 9 yr
U-2781
11766411in 9 yr
U-2781
11963937in 9 yr
U-2780
11963937in 9 yr
U-2781
12064399in 9 yr
U-3988
12064399in 9 yr
U-3989
9949937in 9 yr
U-2421
9956183in 9 yr
U-2422
9956183in 9 yr
U-2423
9956184in 9 yr
U-2424
9956185in 9 yr
U-2425
9956186in 9 yr
U-2426
10918608in 9 yr 4 mo
U-3072
10918608in 9 yr 4 mo
U-3071
10918608in 9 yr 4 mo
U-3073
11065209in 9 yr 4 mo
U-3071
11096905in 9 yr 4 mo
SubstanceProductU-2780
11096905in 9 yr 4 mo
SubstanceProductU-2781
11400055in 9 yr 4 mo
U-3071
11207292in 12 yr 11 mo
SubstanceU-3235
11207292in 12 yr 11 mo
SubstanceU-3277
11207292in 12 yr 11 mo
SubstanceU-3236
11865102in 12 yr 11 mo
SubstanceProductU-2781
11865102in 12 yr 11 mo
SubstanceProductU-3236
11865102in 12 yr 11 mo
SubstanceProductU-3277
11160795in 14 yr 10 mo
U-3233
11406623in 14 yr 10 mo
U-3233
12102619in 14 yr 10 mo
U-3233

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Cannabidiol family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Epidiolex: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 210365 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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