Last Updated: September 24, 2026

AZATADINE MALEATE - Generic Drug Details

Name: AZATADINE MALEATE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic drug sources for azatadine maleate and what is the scope of patent protection?

Azatadine maleate is the generic ingredient in two branded drugs marketed by Schering and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for AZATADINE MALEATE

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	98
DailyMed Link:	AZATADINE MALEATE at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for AZATADINE MALEATE

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for AZATADINE MALEATE

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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
Schering	TRINALIN	azatadine maleate; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	018506-001	Mar 23, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Schering	OPTIMINE	azatadine maleate	TABLET;ORAL	017601-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ 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 AZATADINE MALEATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	OPTIMINE	azatadine maleate	TABLET;ORAL	017601-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Schering	OPTIMINE	azatadine maleate	TABLET;ORAL	017601-001	Approved Prior to Jan 1, 1982	⤷ 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.