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Last Updated: August 4, 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 patent protection?

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, and Lannett Co Inc, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for terbutaline sulfate. Ten 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

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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
Impax Labs TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 075877-002 Jun 26, 2001 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
Akorn TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 078151-001 Jan 7, 2008 AP 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
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-001 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
Pharmacare BRETHINE terbutaline sulfate INJECTABLE;INJECTION 018571-001 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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