Last Updated: June 25, 2026

TERBUTALINE Drug Patent Profile

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

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Which patents cover Terbutaline, and when can generic versions of Terbutaline launch?

Terbutaline is a drug marketed by Areva Pharms, Chartwell Injectable, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Hikma Farmaceutica, Impax Labs, Lannett Co Inc, and Twi Pharms. and is included in nine NDAs.

The generic ingredient in TERBUTALINE is terbutaline sulfate. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Terbutaline

A generic version of TERBUTALINE was approved as terbutaline sulfate by IMPAX LABS on June 26^th, 2001.

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Summary for TERBUTALINE

US Patents:	0
Applicants:	9
NDAs:	9
Drug Prices:	Drug price information for TERBUTALINE
DailyMed Link:	TERBUTALINE at DailyMed

Drug patent expirations by year for TERBUTALINE

US Patents and Regulatory Information for TERBUTALINE

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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
Areva Pharms	TERBUTALINE SULFATE	terbutaline sulfate	INJECTABLE;INJECTION	200122-001	Nov 8, 2013	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Impax Labs	TERBUTALINE SULFATE	terbutaline sulfate	TABLET;ORAL	075877-001	Jun 26, 2001	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Epic Pharma Llc	TERBUTALINE SULFATE	terbutaline sulfate	INJECTABLE;INJECTION	078151-001	Jan 7, 2008		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

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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.