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Last Updated: October 16, 2019

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DORAL Drug Profile

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When do Doral patents expire, and when can generic versions of Doral launch?

Doral is a drug marketed by Galt Pharms and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in DORAL is quazepam. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the quazepam profile page.

Drug patent expirations by year for DORAL
Generic Entry Opportunity Date for DORAL
Generic Entry Date for DORAL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Litigation for DORAL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Lakewood Health System v. TriWest Healthcare Alliance Corp.2007-02-07
APOTEX INC. v. FOOD AND DRUG ADMINISTRATION2006-11-06
AstraZeneca AB v. Dexcel Ltd.2006-05-30

See all DORAL litigation

Pharmacology for DORAL
Drug ClassBenzodiazepine
Synonyms for DORAL
2H-1, 7-chloro-5-(2-fluorophenyl)-1,3-dihydro-1-(2,2,2-trifluoroethyl)-
2H-1,4-Benzodiazepine-2-thione, 7-chloro-5-(2-fluorophenyl)-1,3-dihydro-1-(2,2,2-trifluoroethyl)-
36735-22-5
5-24-04-00356 (Beilstein Handbook Reference)
7-chloro-5-(2-fluorophenyl)-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2h-1,4-benzodiazepine-2-thione
7-chloro-5-(2-fluorophenyl)-1-(2,2,2-trifluoroethyl)-2,3-dihydro-1H-1,4-benzodiazepine-2-thione
7-chloro-5-(2-fluorophenyl)-1-(2,2,2-trifluoroethyl)-3H-1,4-benzodiazepine-2-thione
7-Chloro-5-(o-fluorophenyl)-1,2,2-trifluoroethyl)-2H-1,4-benzodiazepine-2-thione
7-Chloro-5-(o-fluorophenyl)-1,3-dihydro-1-(2,2,2-trifluoroethyl)-2H-1,4-benzodiazepine-2-thione
735Q225
AC1L1JE0
API0004004
BRN 0901084
C07336
C17H11ClF4N2S
Cetrane
CHEBI:8694
CHEMBL1200472
CTK6H1725
D00457
DB01589
DEA No. 2881
Doral (TN)
Doral [Sedative]
Dormalin
DTXSID60190193
EINECS 253-179-4
GTPL7288
IKMPWMZBZSAONZ-UHFFFAOYSA-N
JF8V0828ZI
LS-34123
NSC 309702
NSC-309702
NSC309702
Oniria
Prosedar
Quazapam
quazepam
Quazepam (JAN/USP/INN)
Quazepam [USAN:BAN:INN]
Quazepam [USAN:USP:INN:BAN]
Quazepam civ(200 mg)
Quazepamum
Quazepamum [INN-Latin]
Quazium
Sch 16134
Sch-161
Sch-16134
SCHEMBL29504
Selepam
UNII-JF8V0828ZI
ZINC538266

US Patents and Regulatory Information for DORAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galt Pharms DORAL quazepam TABLET;ORAL 018708-003 Feb 26, 1987 DISCN No No   See Pricing   See Pricing   See Pricing
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 RX Yes Yes   See Pricing   See Pricing   See Pricing
>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 DORAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985   See Pricing   See Pricing
Galt Pharms DORAL quazepam TABLET;ORAL 018708-003 Feb 26, 1987   See Pricing   See Pricing
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985   See Pricing   See Pricing
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985   See Pricing   See Pricing
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985   See Pricing   See Pricing
Galt Pharms DORAL quazepam TABLET;ORAL 018708-003 Feb 26, 1987   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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