FDA Orange Book · active-ingredient family
Dronabinol
Dronabinol: 2 brands, 5 generics; first approved May 31, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
5
Listed patents
4
Next patent expiry
Aug 06, 2028
in 2 yr
Brand (NDA) products
Originator applications
- SYNDROSRLDWELLHOUSE PHARMANDA 2055252017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML SOLUTION ORAL Discontinued — - MARINOLRLDALKEM LABS LTDNDA 01865119853 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB
Generic (ANDA) products (5)
Abbreviated applications
- DRONABINOLASCENT PHARMS INCANDA 20742120203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Rx AB 5MG CAPSULE ORAL Rx AB 10MG CAPSULE ORAL Rx AB - DRONABINOLLANNETT CO INCANDA 20146320183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Discontinued — 5MG CAPSULE ORAL Discontinued — 10MG CAPSULE ORAL Discontinued — - DRONABINOLHIKMAANDA 07921720143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Discontinued — 5MG CAPSULE ORAL Discontinued — 10MG CAPSULE ORAL Discontinued — - DRONABINOLINSYS THERAPANDA 07850120113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Discontinued — 5MG CAPSULE ORAL Discontinued — 10MG CAPSULE ORAL Discontinued — - DRONABINOLRHODESANDA 07829220083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG CAPSULE ORAL Discontinued — 5MG CAPSULE ORAL Discontinued — 10MG CAPSULE ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10265293 | in 2 yr | SubstanceProduct | |
| 9345771 | in 2 yr | SubstanceProduct | |
| 11253472 | in 2 yr | SubstanceProduct | |
| 8222292 | in 2 yr | SubstanceProduct |
Approval history
FDA approval span
First approval
41 yr 10 mo ago
Most recent approval
6 yr 8 mo ago
Approvals span 1985–2020 across 7 FDA applications.
Brand (NDA) 229%
Generic (ANDA) 571%
Dronabinol: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
