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Last Updated: August 15, 2020

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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. One supplier is listed for this compound. Additional details are available on the quazepam profile page.

US ANDA Litigation and Generic Entry Outlook for Doral

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 3, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DORAL
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 16
Patent Applications: 1,944
DailyMed Link:DORAL at DailyMed
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.

Pharmacology for DORAL
Drug ClassBenzodiazepine

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   Start Trial   Start Trial   Start Trial
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 RX Yes Yes   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 DORAL

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.