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Last Updated: October 19, 2019

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Dronabinol - Generic Drug Details

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What are the generic sources for dronabinol and what is the scope of freedom to operate?

Dronabinol is the generic ingredient in three branded drugs marketed by Akorn Inc, Insys Therap, Lannett Co Inc, Svc Pharma, Abbvie, and Insys Dev Co Inc, and is included in six NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dronabinol has four patent family members in four countries.

There are eleven drug master file entries for dronabinol. Eight suppliers are listed for this compound.

Drug Prices for dronabinol

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Recent Clinical Trials for dronabinol

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SponsorPhase
Medical University of GrazPhase 3
Unidata GeodesignPhase 3
Arbeitsgemeinschaft medikamentoese TumortherapiePhase 3

See all dronabinol clinical trials

Recent Litigation for dronabinol

Identify potential future generic entrants

District Court Litigation
Case NameDate
Insys Therapeutics, Inc. v. Alkem Laboratories Ltd.2017-10-10
Insys Therapeutics, Inc. v. Endo Generics Holdings, Inc.2017-08-07
Insys Therapeutics, Inc. v. Par Pharmaceutical, Inc.2017-08-03

See all dronabinol litigation

Pharmacology for dronabinol
Drug ClassCannabinoid
Medical Subject Heading (MeSH) Categories for dronabinol
Synonyms for dronabinol
.delta.-9-THC
.delta.(sup9)-THC
.DELTA.1-Tetrahydrocannabinol
.DELTA.1-THC
.DELTA.9-Tetrahydrocannabinol
.DELTA.9-THC
.DELTA.9-trans-Tetrahydrocannabinol
(-)-.delta.(sup9)-trans-Tetrahydrocannabinol
(-)-.DELTA.1-Tetrahydrocannabinol
(-)-.DELTA.9-Tetrahydrocannabinol
(-)-.DELTA.9-THC
(-)-.DELTA.9-trans-Tetrahydrocannabinol
(-)-(6aR,10aR)-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol
(-)-3,4-trans-Delta1-Tetrahydrocannabinol
(-)-delta(sup 1)-3,4-trans-Tetrahydrocannabinol
(-)-delta(sup 1)-3,4-trans-Tetrahydrocannabinol(l)-delta(sup 1)-Tetrahydrocannabinol
(-)-delta1-Tetrahydrocannabinol
(-)-delta9-(trans)-Tetrahydrocannabinol
(-)-delta9-Tetrahydrocannabinol
(-)-Delta9-Tetrahydrocannabinol solution
(-)-Delta9-Tetrahydrocannabinol solution, ~1 mg/mL in ethanol, analytical standard, for drug analysis
(-)-Delta9-THC (Dronabinol) 0.1 mg/ml in Methanol
(-)-Delta9-THC (Dronabinol) 1.0 mg/ml in Methanol
(-)-Delta9-THC (Dronabinol) 5.0 mg/ml in Methanol
(-)-delta9-trans-Tetrahydrocannabinol
(-)-trans-.DELTA.9-Tetrahydrocannabinol
(-)-trans-Delta1-Tetrahydrocannabinol
(-)-trans-delta9-Tetrahydrocannabinol
(-)-trans-Delta9-THC
(-)-trans-Delta9-THC solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
(10R,10aR)-6,6,9-Trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol
(6aR-trans)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo(b,d)pyran-1-ol
(6aR-trans)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol
(6aR,10aR)-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol
(6aR,10aR)-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydrobenzo[c]chromen-1-ol
(6AR,10AR)-6,6,9-TRIMETHYL-3-PENTYL-6H,6AH,7H,8H,10AH-BENZO[C]ISOCHROMEN-1-OL
(6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo(b,d)pyran-1-ol
(6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol
(6aS,10aS)-6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol
(L)-.delta.1-Tetrahydrocannabinol
(l)-delta(sup 1)-Tetrahydrocannabinol
(l)-delta1-Tetrahydrocannabinol
(S)-6,6,9-Trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol
1-trans-.delta.(sup9)-tetrahydrocannabinol
1-trans-D9-Tetrahydrocannabinol
1-trans-delta-9-Tetrahydrocannabinol
1-trans-delta(sup 9)-Tetrahydrocannabinol
1-trans-delta(sup9)-tetrahydrocannabinol
1-trans-delta9-Tetrahydrocannabinol
124699-EP2272825A2
124699-EP2289509A2
124699-EP2295426A1
124699-EP2295427A1
1363-19-5
14146-29-3
14146-43-1
148820-EP2289509A2
14C-.DELTA.1-Tetrahydrocannabinol
1972-08-3
23623-EP2269989A1
23623-EP2275420A1
23623-EP2298764A1
23623-EP2298765A1
23623-EP2298772A1
23623-EP2308839A1
23623-EP2314298A1
23623-EP2314580A1
26108-45-2
3-Pentyl-6,6,9-trimethyl-6a,7,8,10a-tetrahydro-6H-dibenzo(b,d)pyran-1-ol
3-pentyl-6,6,9-trimethyl-6a,7,8,10a-tetrahydro-6H-dibenzo[b,d]pyran-1-ol
3ls4
5957-27-7
6,6,9-Trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol
6,6,9-Trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol(delta9-THC(delta9-tetrahydrocannabinol))
6,6,9-Trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol(DeltaE-9-THC)
6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-dibenzo[b,d]pyran-1-ol
6,6,9-Trimethyl-3-pentyl-7,8,9,10-tetrahydro-6H-dibenzo(b,d)pyran-1-ol
6,9-Trimethyl-3-pentyl-7,8,9,10-tetrahydro-6H-dibenzo[b,d]pyran-1-ol
6465-30-1
6H-Dibe nzo[b,d]pyran-1-ol,6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, (6aR-trans)-
6H-Dibenzo
6H-Dibenzo(b,d)pyran-1-ol, 6a,7,8,10a-tetrahydro-3-pentyl-6,6,9-trimethyl- (6ar-trans)-
6H-Dibenzo(b,d)pyran-1-ol, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, (6aR-trans)-
6H-Dibenzo(b,d)pyran-1-ol, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, (6aR,10aR)-
6H-Dibenzo(b,d)pyran-1-ol, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, trans-
6H-Dibenzo[b, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-
6H-Dibenzo[b, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, (6aR-trans)-
6H-Dibenzo[b, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, trans-
6H-Dibenzo[b,d]pyran-1-ol, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, (6aR-trans)-
6H-dibenzo[b,d]pyran-1-ol, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, (6aR,10aR)-
6H-Dibenzo[b,d]pyran-1-ol,6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-, (6aR-trans)-
7J8897W37S
8,8-Dimethyl-11-methylene-5-pentyl-3,4,8a,9,10,11,12,12a-octahydro-2H,8H-1,7-dioxa-benzo[c]phenanthrene
9-delta-Tetrahydrocannabinol
9-ene-Tetrahydrocannabinol
9-tetrahydrocannabinol
9-THC
Abbott 40566
AC1L277U
AC1Q2VRZ
API0002497
BDBM50007391
BDBM60994
BIDD:GT0427
C06972
Cannabinol, .DELTA.1-tetrahydro-
Cannabinol, 1-trans-.delta.(sup9)-tetrahydro-
Cannabinol, 1-trans-delta(sup 9)-tetrahydro-
Cannabinol, delta1-tetrahydro-
Cannabinol, Delta1-tetrahydro- (7CI)
Cannabinol, tetrahydro- (6CI)
Cannabis resin
CAS-1972-08-3
CAT-310
CCRIS 4726
CHEBI:66964
CHEMBL465
Compassia
CTK8D8346
CYQFCXCEBYINGO-IAGOWNOFSA-N
D00306
DB00470
DEA No. 7369
DEA No. 7370
delta 9-Tetrahydrocannabinol
delta-9 Tetrahydrocannabinol
delta-9-tetrahydrocannabinol
Delta-9-Tetrahydrocannabinol, United States Pharmacopeia (USP) Reference Standard
delta-9-THC
delta-THC
delta(1)-Tetrahydrocannabinol
delta(1)-THC
delta(9)-Tetrahydrocannabinol
delta(9)-Tetrahydrocannibinol
delta(9)-THC
delta(sup 1)-Tetrahydrocannabinol
delta(sup 1)-Thc
delta(sup 9)-Tetrahydrocannabinol
delta(sup 9)-Thc
delta1-Tetrahydrocannabinol
delta1-Tetrahydrocannabinol (VAN)
delta1-THC
delta9-Tetrahydrocannabinol
delta9-Tetrahydrocannabinol (VAN)
Delta9-Tetrahydrocannabinol solution, 1.0 mg/mL in methanol, analytical standard, for drug analysis
Delta9-Tetrahydrocannabinol solution, ethanol solution
delta9-THC
delta9-trans-Tetrahydrocannabinol
Deltanyne
DRG-0138
Drona binol
Dronabinol (USP/INN)
Dronabinol [USAN:INN]
Dronabinol [USAN:USP:INN]
Dronabinol in sesame oil and encapsulated in a soft gelatin capsule in a U.S. FDA approved drug product
Dronabinol in sesame oil in soft gelatin capsule
Dronabinolum
Dronabinolum [Latin]
DSSTox_CID_1327
DSSTox_GSID_21327
DSSTox_RID_76083
DTXSID6021327
Epitope ID:224552
Ganja
GTPL2424
Hashish
HSDB 6471
INT-0010
INT-0010/06
L-.delta.1-Tetrahydrocannabinol
L-.delta.1-trans-Tetrahydrocannabinol
L-delta(sup 1)-tetrahydrocannabinol
L-delta1-trans-Tetrahydrocannabinol
L-trans-.delta.9-Tetrahydrocannabinol
L-trans-delta9-Tetrahydrocannabinol
LS-975
Marinol
Marinol (TN)
Namisol
NSC 134454
NSC-134454
NSC134454
PDSP2_000714
QCD 84924
QCD-84924
Relivar
SCHEMBL4609
SP 104
Syndros
Synthetic THC in sesame oil / soft gelatin
Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-di benzo[b,d]pyran-1-ol
Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo(b,d)pyran-1-ol
Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol
TETRAHYDROCANNABINOL
Tetrahydrocannabinol delta9
Tetrahydrocannabinols (-)-delta1-3,4-trans-form
THC
THC-delta-9
Tox21_112616
trans-.DELTA.9-Tetrahydrocannabinol
trans-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo(b,d)pyran-1-ol
trans-delta-9-Tetrahydrocannabinol
trans-delta9-Tetrahydrocannabinol
trans-tetrahydrocannabinol
UNII-7J8897W37S
UNII-K4H93P747O component CYQFCXCEBYINGO-IAGOWNOFSA-N
US9416103, Delta9-THC
ZINC1530625

US Patents and Regulatory Information for dronabinol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Insys Dev Co Inc SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Akorn Inc DRONABINOL dronabinol CAPSULE;ORAL 079217-003 Jun 20, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc DRONABINOL dronabinol CAPSULE;ORAL 201463-003 May 18, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Insys Therap DRONABINOL dronabinol CAPSULE;ORAL 078501-002 Aug 19, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for dronabinol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie MARINOL dronabinol CAPSULE;ORAL 018651-001 May 31, 1985   Start Trial   Start Trial
Abbvie MARINOL dronabinol CAPSULE;ORAL 018651-003 May 31, 1985   Start Trial   Start Trial
Abbvie MARINOL dronabinol CAPSULE;ORAL 018651-002 May 31, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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