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DORAL Drug Patent 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.

DrugPatentWatch^® 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	22
Patent Applications:	3,676
What excipients (inactive ingredients) are in DORAL?	DORAL excipients list
DailyMed Link:	DORAL at DailyMed

Drug patent expirations by year for DORAL

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DORAL

Generic Entry Date for DORAL^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 018708 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 Class	Benzodiazepine

Anatomical Therapeutic Chemical (ATC) Classes for DORAL

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for DORAL

DORAL is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DORAL is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DORAL

Methods for reducing the risk of an adverse drug interaction in a patient suffering from insomnia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION

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Glossary

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

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

International Patents for DORAL

See the table below for patents covering DORAL around the world.

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Country	Patent Number	Title	Estimated Expiration
Ireland	51604	AMINOALKYL FURAN DERIVATIVE	⤷ Try a Trial
Switzerland	652122	DERIVE D'AMINOALCOYL FURANNE, PROCEDE POUR SA PREPARATION ET COMPOSITION PHARMACEUTIQUE COMPRENANT CE DERIVE.	⤷ Try a Trial
Italy	1143237	DERIVATO DI AMMINOALCHILFURANO PROCEDIMENTO PER PRODURLO E COMPOSIZIONE FARMACEUTICA CHE LO CONTIENE	⤷ Try a Trial
Japan	H0443070		⤷ Try a Trial
Denmark	427182		⤷ Try a Trial
Slovakia	277922		⤷ Try a Trial
Denmark	33792		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration