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Last Updated: December 14, 2019

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SYNDROS Drug Profile

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Which patents cover Syndros, and what generic alternatives are available?

Syndros is a drug marketed by Insys Dev Co Inc and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has four patent family members in four countries.

The generic ingredient in SYNDROS is dronabinol. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dronabinol profile page.

US ANDA Litigation and Generic Entry Outlook for Syndros

A generic version of SYNDROS was launched as dronabinol by SVC PHARMA on December 14th, 2019.

Drug patent expirations by year for SYNDROS
Drug Prices for SYNDROS

See drug prices for SYNDROS

Recent Clinical Trials for SYNDROS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ArizonaEarly Phase 1

See all SYNDROS clinical trials

Recent Litigation for SYNDROS

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 SYNDROS litigation

Synonyms for SYNDROS
.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
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
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 SYNDROS

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
Insys Dev Co Inc SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Insys Dev Co Inc SYNDROS dronabinol SOLUTION;ORAL 205525-001 Mar 23, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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