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Last Updated: August 12, 2020

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Terbutaline sulfate - Generic Drug Details

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What are the generic drug sources for terbutaline sulfate and what is the scope of freedom to operate?

Terbutaline sulfate is the generic ingredient in four branded drugs marketed by Novartis, Sanofi Aventis Us, Pharmacare, Akorn, Athenex Inc, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, United Biomedcl, Ani Pharms Inc, Impax Labs, Lannett Co Inc, and Twi Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for terbutaline sulfate. Eleven suppliers are listed for this compound.

Drug Prices for terbutaline sulfate

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Recent Clinical Trials for terbutaline sulfate

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SponsorPhase
University of Mississippi Medical CenterN/A
American University of Beirut Medical CenterPhase 3

See all terbutaline sulfate clinical trials

Medical Subject Heading (MeSH) Categories for terbutaline sulfate

US Patents and Regulatory Information for terbutaline sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett Co Inc TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 077152-001 Mar 25, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Athenex Inc TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 076770-001 Apr 23, 2004 AP RX No Yes   Start Trial   Start Trial   Start Trial
Novartis BRETHAIRE terbutaline sulfate AEROSOL, METERED;INHALATION 018762-001 Aug 17, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Farmaceutica TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 078630-001 May 20, 2009 AP RX No No   Start Trial   Start Trial   Start Trial
United Biomedcl TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 200122-001 Nov 8, 2013 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 076887-001 May 26, 2004 AP RX No No   Start Trial   Start Trial   Start Trial
Twi Pharms TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 211832-002 Jun 19, 2020 AB RX 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 terbutaline sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacare BRETHINE terbutaline sulfate INJECTABLE;INJECTION 018571-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Novartis BRETHAIRE terbutaline sulfate AEROSOL, METERED;INHALATION 018762-001 Aug 17, 1984   Start Trial   Start Trial
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Sanofi Aventis Us BRICANYL terbutaline sulfate INJECTABLE;INJECTION 017466-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Ani Pharms Inc BRETHINE terbutaline sulfate TABLET;ORAL 017849-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Sanofi Aventis Us BRICANYL terbutaline sulfate AEROSOL, METERED;INHALATION 018000-001 Mar 19, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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