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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. One supplier is 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:	1
Raw Ingredient (Bulk) Api Vendors:	22
Patent Applications:	3,511
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

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 ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	018708-003	Feb 26, 1987	⤷ Sign Up	⤷ Sign Up
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985	⤷ Sign Up	⤷ Sign Up
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985	⤷ Sign Up	⤷ Sign Up
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985	⤷ Sign Up	⤷ Sign Up
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985	⤷ Sign Up	⤷ Sign Up
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-003	Feb 26, 1987	⤷ Sign Up	⤷ Sign Up
>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
Philippines	13540	AMINOALKYL FURAN DERIVATIVES	⤷ Sign Up
Sweden	454882	FORFARANDE FOR FRAMSTELLNING AV AMINOALKYLFURANDERIVAT MED TERAPEUTISK VERKAN	⤷ Sign Up
Netherlands	7708601		⤷ Sign Up
Austria	402069		⤷ Sign Up
Slovakia	403591	2-RANITIDINE HYDROCHLORIDE FORM, METHOD OF ITS PREPARATION AND PHARMACEUTICAL PRODUCT WITH ITS CONTENTS	⤷ Sign Up
Switzerland	642072	Process for the preparation of aminoalkylfuran derivatives	⤷ Sign Up
Denmark	167794		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration