Viewing data from:

MARINOL

NDA

DRONABINOL | N018651 | ALKEM LABORATORIES LTD

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Summit Biosciences, Inc., et al (K&L Gates, LLC) - Citizen Petition FDA-2010-P-0353 · 6 docket documents Summit Biosciences Inc. and an unnamed Kentucky university filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine a new nasal spray dosage form of dronabinol (synthetic delta-9-tetrahydrocannabinol) is suitable for filing unde	Other	2010-07-06	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

75 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 54 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Influence of a Medicinal Cannabinoid Agonist on Responses to Food Images and Food Intake NCT02310347	N/A	Active	Universitaire Ziekenhuizen KU Leuven	18	2014-12 → 2025-10
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III NCT02710331	Phase 1	Active	Yale University	40	2016-03 → 2026-12
Effects of Dronabinol in Opioid Maintained Patients NCT04025359	Early Phase 1	Recruiting	Yale University	36	2019-05-31 → 2026-09-01
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I NCT02811510	Phase 1	Recruiting	Yale University	40	2016-06 → 2026-12
Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain NCT01318369	Phase 2	Completed	Radboud University Medical Center	24	2011-10 → 2013-05
Comparison of the Analgesic Effects of Dronabinol and Smoked Marijuana in Daily Marijuana Smokers NCT00743119	Phase 2	Completed	New York State Psychiatric Institute	34	2008-06 → 2013-05
Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse NCT00373503	Phase 2	Completed	New York State Psychiatric Institute	8	2005-08 → 2008-09
Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)NCT00812851	N/A	Completed	Cantonal Hospital of St. Gallen	24	2005-04 → 2008-04
A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome NCT00000737	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	56	—
Effects of Delta-9 Tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R61 Study NCT03008005	Phase 4	Completed	Wayne State University	46	2017-06-01 → 2019-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$26.69

Highest Price

$535.46

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
53097-0571-60MARINOL 2.5MG CAP	$535.46	FSS	Ascend Laboratories, LLC	02/29/2028
67877-0754-60DRONABINOL 5MG CAP	$34.11	FSS	Ascend Laboratories, LLC	02/29/2028
67877-0753-60DRONABINOL 2.5MG CAP	$26.69	FSS	Ascend Laboratories, LLC	02/29/2028
67877-0755-60DRONABINOL 10MG CAP	$69.74	FSS	Ascend Laboratories, LLC	02/29/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain5 active DMFs7 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

S AND B PHARMA LLC DBA NORAC PHARMADRONABINOL

DMF 150822000

BENUVIA OPERATIONS LLCDRONABINOL USP

DMF 192072006

PURISYS LLCDRONABINOL DRUG SUBSTANCE IN SESAME OIL

DMF 206822007

S AND B PHARMA INC DBA NORAC PHARMADRONABINOL USP

DMF 301962016

PURISYS LLCDRONABINOL DRUG SUBSTANCE

DMF 362202021

MALLINCKRODT INCInactiveDRONABINOL IN SESAME OIL

DMF 176292004

RESOLUTION CHEMICALS LTDInactiveDRONABINOL USP

DMF 187312005

PURISYS LLCInactiveDRONABINOL, 10% IN SESAME OIL

DMF 193352006

CURIA NEW YORK INCInactiveDRONABINOL IN SESAME OIL DRUG SUBSTANCE

DMF 205962007

BIONORICAInactiveDRONABINOL USP

DMF 208232007

CATALENT PHARMA SOLUTIONS LLCInactiveDRONABINOL CAPSULES USP 2.5MG, 5.0MG, 10.0MG (CIII) SA

DMF 238422010

CURIA NEW YORK INCInactiveDRONABINOL IN ETHANOL DRUG SUBSTANCE

DMF 300942015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Mar 27, 2026	SUPPL -36	View Letter (PDF)
Jan 18, 2023	SUPPL -33	View Letter (PDF)
Aug 30, 2017	SUPPL -29	View Letter (PDF)
Jun 28, 2006	SUPPL -25	View Letter (PDF)
Jun 28, 2006	SUPPL -26	View Letter (PDF)
Apr 28, 2005	SUPPL -21	View Letter (PDF)
May 29, 2003	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 31, 1985

No patent or exclusivity listings for this strength.

#002 — 5MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 31, 1985

#003 — 10MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 31, 1985